JAK2 V617F mutation detection

Transport arrangements

Specimens should be kept at room temperature and sent directly to the laboratory as soon as possible by first class post.

Sample storage arrangements

Specimens must NOT be frozen. If a delay in sending a specimen is unavoidable it must be refrigerated overnight.

How to request

Request form/ TRAK request.

Availability

Test not available during restricted service.

Anticipated turnaround

21 days

What happens if the result is positive or abnormal

Genetic results will not be telephoned. They can be emailed if secure addresses are verified.

Static information/disclaimer

This test is accredited to ISO 15189:2022

General additional information

The presence of the JAK2 V617F mutation is associated with myeloproliferative neoplasms, including polycythaemia vera, essential thrombocythaemia and myelofibrosis. This variant should not be present in normal individuals. See the relevant BCSH guidelines for further information.

Citrated anticoagulated venous blood or 150µl DNA may be sent instead of an EDTA specimen

Container_Adult1
Volume - Adult 1

​2.7ml

Additive - Adult 1

​EDTA

Viral Haemorrhagic Fever testing

Transport arrangements
Arranged by SNVTS –
The local hospital team/ laboratory should provide SNVTS by telephone with details of the sample shipment (driver identity, vehicle registration, courier organisation, tracking number, contact telephone number and estimated time of arrival at the Royal Infirmary of Edinburgh). If SNVTS instructs collection directly (see above), the test service will gather such data from the courier.
 

​Please refer to the Scottish Viral Haemorrhagic Test Service Brief User Guide

Sample storage arrangements

​​Special precautions: If processing is delayed, storage at ambient temperature is preferred. Delays of over 24 hrs are undesirable.

Special instructions for collection
Samples required
2 x EDTA blood (minimum 2ml ) e.g in 2.7ml tube
and 1 x Clotted blood (minimum 2ml) e.g in 4.9 ml tube
and if possible 1 x urine ( minimum 1ml)
 

Please refer to the Scottish Viral Haemorrhagic Test Service Brief User Guide

How to request

​Use appropriate request form: SNVHF Test Form



Forms must be fully completed with Patient Identifier Number (CHI), Forename, Surname, Date of birth, Gender and location of patient.

Availability

​7 days a week, 24 hours a day.

Anticipated turnaround

​1 day

What happens if the result is positive or abnormal

​All results conveyed to the Duty Virologist or On-Call Virologist.

General additional information
Specific information: Please note that samples to be sent to SNVTS for testing should NOT be processed in any manner by the local hospitalteam/ laboratory. Instead, the samples above should be sent intact and unprocessed. There is no cost incurred to Scottish Health Boards for VHF testing at SNVTS.
 
Factors known to significantly affect the results: Haemolysis
 
Clinical information: This test is only performed on patients where there is prior agreement from IFS that testing is appropriate.

Levetiracetam

Anticipated turnaround

​28 days

General additional information

​For gel tubes, separate serum/plasma ASAP.

Container_Adult1
Container_Adult2
Container_Adult3
Container_Child1
Volume - Child 1

​1mL

Additive - Child 1

​Lithium-heparin

Volume - Adult 1

​1mL

Volume - Adult 2

​1mL

Volume - Adult 3

​1mL

Additive - Adult 1

​Lithium-heparin

Additive - Adult 2

​None

Additive - Adult 3

​K-EDTA

Hyaluronic acid

Availability

​Test only available to the following specialties: GI, dermatology and rheumatology

Anticipated turnaround

​7 days

General additional information

Background

Hyaluronic acid (HA) is an unbranched glycosaminoglycan, produced mainly in mesenchymal cells and is widely distributed in connective tissue throughout the body.1,2 Liver is an significant source of HA.  It has several physiological functions, e.g. lubrication in joints, prevention from bacterial invasion and internal body hydration.  In patients with developing fibrotic liver disease, serum levels of HA increase.  Serum concentration of HA is consistent with stage of fibrosis, and also decreases with a response to interferon therapy in patients with HCV chronic infection.3‑9  It therefore has very useful clinical utility as a non-invasive marker to exclude cirrhosis. 10  HA has been available in Lothian for many years. Testing was originally carried out by the Hepatology laboratory at the University of Edinburgh, before the service transferred in 2019 to NHS Lothian Department of Clinical Biochemistry.  The service is available to gastroenterology, dermatology and rheumatology with cross charging arrangements in place.

 

Laboratory Clinical Interpretation

In NHS Lothian a reference range of <60 ng/mL is used.  At this cut-off concentration of 60 ng/mL, HA typically shows a negative predictive value of up to 100% and a positive predictive value of 61% for cirrhosis.11, 12  In practice, values over 100 ng/mL are suggestive of cirrhosis however values normally exceed this.  In contrast, values less than 60 ng/mL are very reassuring, especially if combined with a normal Fibroscan and FIB4 score.  The lower analytical limit of the assay has been revised to 50 ng/mL from August 2021 due to inadequate performance below this level. This means a result of less than 50 will now appear on reports as “<50 ng/mL” and is unlikely to be clinical significant.

 

Serum HA concentrations in patients with conditions such as rheumatoid arthritis, osteoarthritis and systemic lupus erythematosis need to be interpreted with the knowledge that these conditions may also cause elevated results.11 Values of 50-100 ng/mL are common in the elderly and most likely reflect joint damage.

 

How often is monitoring hyaluronic acid required?

Colleagues in Hepatology (NHS Lothian) suggest monitoring more frequently than once every 2 years is unlikely to be helpful in most cases.  Repeat requests within 18 months will no longer be processed (unless it is to confirm a new result >60 ng/mL).

 

Indications for Fibroscan and hepatology referral

For individuals with a newly elevated hyaluronic acid (i.e. >60 ng/mL), suggest repeat and if >60ng/mL on repeat specimen, refer for Fibroscan.

 

For individuals with a new finding of hyaluronic acid >100 ng/mL, suggest repeat and if >100ng/mL on repeat specimen, refer for Fibroscan and a hepatology referral.

 

References

1. Stryer T., et al.: Biochemistry (Third Edition). 1988; 275-277.

2. Laurent T.C., et al.: Ciba foundation Symposium. 1986; 124: 9–29.

3. Oberti F., et al.: Gastroenterology. 1997; 113(5): 1609-1616.

4. Plevris J.N., et al.: Eur J Gastroenterol Hepatol. 2000; 12(10): 1121-1127.

5. Guéchot J., et al.: J Hepatol. 1995; 22 (2 Suppl): 103-106.

6. Pares A., et al.: Hepatology. 1996; 24 (6): 1399-1403.

7. Yamada M., et al.: J Gastroenterol Hepatol. 1996; 11(7): 646-651.

8. Sandra J., et al.: Hepatology. 2004; 40 (4): 1200, 687A.

9. Suzuki A., et al.: Liver Int. 2005; 25 (4): 779-786.

10. Gudowska M., et al.: Acta Biochim Pol. 2017; 64(3): 451-457.

11. Frébourg T. et al.: Hepatology. 1986; 6(3):392-395.

12. Majid M. et al.: Ann Rheum Dis. 2004; 63: 1166-1168.

Container_Adult1
Volume - Child 1

​1 mL

Additive - Child 1

​None

Volume - Adult 1

​1 mL

Additive - Adult 1

​None

Myositis Screen

Special instructions for collection

Serum samples only please.

How to request

​All requests for this test must be made through Clinical Immunology and on a Clinical Immunology request form.

Specialist test must be cleared by Consultant Immunologist.

Availability

​Normal working hours Mon to Fri 9am to 5pm.

Anticipated turnaround

​21 Days

General additional information

​Please refer to Dundee Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Anti-Ganglioside

Special instructions for collection

Serum samples only please.

How to request

​All requests for this test must be made through Clinical Immunology and on a Clinical Immunology request form.

 

Availability

​Normal working hours Mon to Fri 9am to 5pm.

Anticipated turnaround

21 Days

General additional information

​Please refer to Glasgow Neuroimmunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Pemphigoid/Pemphigus

Special instructions for collection

Serum samples only please.

How to request

​All requests for this test must be made through Clinical Immunology and on a Clinical Immunology request form.

 

Availability

​Normal working hours Mon to Fri 9am to 5pm.

Anticipated turnaround

​21 Days

General additional information

​Please refer to Sheffield Immunology Laboratory for current accreditation information and reference ranges.

 

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Insulin Antibody

Special instructions for collection

Serum samples only please.

How to request

​All requests for this test must be made through Clinical Immunology and on a Clinical Immunology request form.

 

Availability

​Normal working hours Mon to Fri 9am to 5pm.

Anticipated turnaround

​21 Days

General additional information

​Please refer to Sheffield Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Histone Antibodies

Special instructions for collection

Serum samples only please.

How to request

​All requests for this test must be made through Clinical Immunology and on a Clinical Immunology request form.

Availability

​Normal working hours Mon to Fri 9am to 5pm.

Anticipated turnaround

​21 Days

General additional information

​Please refer to Sheffield Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Adrenal, Ovary & Testes Antibodies

Special instructions for collection

Serum samples only please.

How to request

​All requests for this test must be made through Clinical Immunology and on a Clinical Immunology request form.

 

Availability

​Normal working hours Mon to Fri 9am to 5pm.

Anticipated turnaround

​21 Days

General additional information

​Please refer to Sheffield Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

C1Q Antibody

Special instructions for collection

Serum samples only please.

How to request

​All requests for this test must be made through Clinical Immunology and on a Clinical Immunology request form.

Specialist test must be cleared by Consultant Immunologist.

Availability

​Normal working hours Mon to Fri 9am to 5pm

Anticipated turnaround

​21 Days

General additional information

​Please refer to Sheffield Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

C1Q Level

Transport arrangements

Special instructions for collection

Serum samples only please.

​Sample must be received in the laboratory within 2 hours of venesection, and by prior arrangement.

How to request

​All requests for this test must be made through Clinical Immunology and on a Clinical Immunology request form.

Specialist test must be cleared by Consultant Immunologist.

Availability

​Normal working hours Mon to Fri 9am to 5pm

Anticipated turnaround

​21 Days

General additional information

​Please refer to Sheffield Immunology Laboratory for current accreditation information and reference ranges.

 

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

AP50/AP100 (Alternative Complement Pathway)

Transport arrangements

​ 

Special instructions for collection

​Sample must be received in the laboratory within 2 hours of venesection, and by prior arrangement.

Serum samples only please.

How to request

​All requests for this test must be made through Clinical Immunology and on a Clinical Immunology request form.

Specialist test must be cleared by Consultant Immunologist.

Availability

​Normal working hours Mon to Fri 9am to 5pm.

Anticipated turnaround

​21 Days

General additional information

​Please refer to Sheffield Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

CH50 (Classic Complement Pathway)

Special instructions for collection

​Sample must be received in the laboratory within 2 hours of venesection, and by prior arrangement.

Serum samples only please.

How to request

​All requests for this test must be made through Clinical immunology and on a Clinical Immunology request form.

Specialist test must be cleared by Consultant Immunologist.

Availability

​Normal Working hours Mon to Fri 9am to 5pm.

Anticipated turnaround

​21 Days

General additional information

​Please refer to Sheffield Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

C1 Esterase Inhibitor Function & Level

Transport arrangements

.

Special instructions for collection

​Sample must be received in the laboratory within 4 hours of venesection, and by prior arrangement.

Serum samples only please.

How to request

​All requests for this test must be made through Clinical Immunology email at ImmunologyLabs@nhslothian.scot.nhs.uk

Availability

​Normal working hours Mon to Fri 9am to 5pm.

Anticipated turnaround

​21 Days

General additional information

​Please refer to Sheffield Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

LGI1/CASPR2 Antibodies

Special instructions for collection

Can be performed on both serum and CSF.

How to request

​All requests for this test must be made through Clinical Immunology on a Clinical Immunology request form.

 

Availability

​Normal working hours Mon to Fri 9am to 5pm

Anticipated turnaround

​21 Days

General additional information

​Please refer to Oxford Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Voltage Gated K+ Channel (VGKC)

Special instructions for collection

Can be performed on both serum and CSF.

How to request

​All requests for this test must be made through Clinical Immunology on a Clinical Immunology request form.

 

 

 

Availability

​Normal working hours Mon to Fri 9am to 5pm

Anticipated turnaround

​21 Days

General additional information

​Please refer to Oxford Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Voltage Gated Ca+ Channel (VGCC)

Special instructions for collection

Can be performed on both serum and plasma samples.

How to request

​All requests for this test must be made through Clinical Immunology on a Clinical Immunology request form.

Availability

​Normal working hours Mon to Fri 9am to 5pm

Anticipated turnaround

​21 Days

General additional information

​Please refer to Oxford Immunology laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Fixed and Live NMDA Receptor Antibodies

Special instructions for collection

​Can be performed on both serum and CSF

How to request

​All requests for this test must be made through Clinical Immunology on a Clinical Immunology request form.

 

Availability

​Normal working hours Mon to Fri 9am to 5pm

Anticipated turnaround

​21 Days

General additional information

​Please refer to Oxford Immunology Laboratory for current accreditation information and reference ranges.

 

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Anti-MUSK Antibodies

Special instructions for collection

Serum samples only please.

How to request

​All requests for this test must be made through Clinical Immunology on a Clinical Immunology request form.

 

Availability

​Normal working hours Mon to Fri 9am to 5pm

Anticipated turnaround

​21 Days

General additional information

​Please refer to Oxford Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Myelin Oligodendrocyte Glycoprotein Antibodies (MOG)

Special instructions for collection

Can be performed on both serum and CSF.

How to request

​All requests for this test must be made through Clinical Immunology on a Clinical Immunology request form.

Availability

​Normal working hours Mon to Fri 9am to 5pm

Anticipated turnaround

​21 Days

General additional information

​Please refer to Oxford Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Myelin Associated Glycoprotein (MAG)

Special instructions for collection

Serum samples only please.

How to request

​All requests for this test must be made through Clinical Immunology on a Clinical Immunology request form.

 

Availability

​Normal working hours Mon to Fri 9am to 5pm

Anticipated turnaround

​21 Days

General additional information

​Please refer to Oxford Immunology laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Glycine Receptor Antibodies

Special instructions for collection

Can be performed on both serum and CSF.

How to request

​All requests for this test must be made through Clinical Immunology on a Clinical Immunology request form.

 

Availability

​Normal working hours Mon to Fri 9am to 5pm

Anticipated turnaround

​21 Days

General additional information

​Please refer to Oxford Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

GABA/AMP1/AMP2

Special instructions for collection

Can be performed on both serum and CSF.

How to request

​All requests for this test must be made through Clinical Immunology on a Clinical Immunology request form.

 

Availability

​Normal working hours Mon to Fri 9am to 5pm

Anticipated turnaround

​21 Days

General additional information

​Please refer to Oxford Immunology laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Aquaporin 4 Antibody

Special instructions for collection

Serum or CSF can be used.

How to request

​All requests for this test must be made through Clinical Immunology on a Clinical Immunology request form.

 

Availability

​Normal working hours Mon to Fri 9am to 5pm

Anticipated turnaround

​21 Days

General additional information

​Please refer to Oxford Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Anti-Yo, Hu and Ri (Paraneoplastic/Neuronal Antibodies)

Special instructions for collection

Serum or CSF samples can be used.

How to request

​All requests for this test must be made through Clinical Immunology on a Clinical Immunology request form.

 

Availability

​Normal working hours Mon to Fri 9am to 5pm

Anticipated turnaround

​21 Days

General additional information

​Please refer to Oxford Immunology Laboratory for current accreditation information and reference ranges.

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Acetyl Choline Receptor Antibodies (ACH)

Special instructions for collection

Serum samples only please.

How to request

​All Requests for this test must be made through Clinical Immunology on a Clinical Immunology request form.

 

Availability

​Normal Working hours Mon to Fri 9am to 5pm.

Anticipated turnaround

​21 Days

General additional information

​Please refer to Oxford Immunology Laboratory for current accreditation information and reference ranges.

 

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

HIT Assay (HIT IgG)

Transport arrangements

​This is an URGENT test - samples must be transported to the laboratoy as soon as possible (by taxi or courier, where appropriate).

Sample storage arrangements

​None required.

Special instructions for collection

​None required.

Please note: BOTH plasma and serum samples are required for HIT testing.

How to request

​This test MUST be arranged via the Haematology medical staff.

Availability

​24/7

Anticipated turnaround

​24 hours

What happens if the result is positive or abnormal

​All results are telephoned to the haematology Registrar and referred to the consultant Haematologist for comments.

Container_Adult1
Container_Child1
Volume - Child 1

1.1mL brown gel paediatric tube

Additive - Child 2

​Sodium Citrate

Volume - Adult 1

4.9ml Sarstedt tube

Additive - Adult 2

​Sodium Citrate

Urea (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is accredited to ISO15189 for peritoneal and drain fluid.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

Container_Adult1
Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

Osmolality (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is currently unaccredited to ISO 15189 for fluid analysis.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

Container_Adult1
Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

Urate (fluid)

Transport arrangements

If patient is on rasburicase transport to the laboratory on ice immediately.

Anticipated turnaround

1 day

Static information/disclaimer

This test is currently unaccredited to ISO 15189 for fluid analysis.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

Container_Adult1
Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

Triglycerides (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is accredited to ISO 15189 for pleural and peritoneal fluid.

General additional information

Main indication: query chylothorax.

If cloudy after centrifugation, inspection for chylomicrons may be required.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

Container_Adult1
Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

Protein, total (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is accredited to ISO15189 for pleural and peritoneal fluid.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

Container_Adult1
Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

Sodium (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is currently unaccredited to ISO 15189 for fluid analysis.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

Container_Adult1
Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

Potassium (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is currently unaccredited to ISO 15189 for fluid analysis.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

Container_Adult1
Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

pH (fluid)

Special instructions for collection

Should be collected anaerobically - expel air bubbles from the syringe.

Anticipated turnaround

1 day

Static information/disclaimer

This test is currently unaccredited to ISO 15189 for fluid analysis.

General additional information

All fluids must be free from particles. Measured on a blood gas analyser using a clot filter.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

Container_Adult1
Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​Heparin

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​Heparin

Magnesium (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is currently unaccredited to ISO 15189 for fluid analysis.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

Container_Adult1
Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

Lactate dehydrogenase (LDH, fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is accredited to ISO 15189 for pleural and peritoneal fluid.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

Container_Adult1
Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

Glucose (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is accredited to ISO 15189 for pleural, peritoneal and drain fluid.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

Container_Adult1
Container_Child1
Volume - Child 1

​0.2 mL

Additive - Child 1

​F-EDTA

Volume - Adult 1

​0.2 mL

Additive - Adult 1

​F-EDTA

Creatinine (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is accredited to ISO 15189 for peritoneal and drain fluid.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

Container_Adult1
Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

Cholesterol (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is accredited to ISO 15189 for pleural fluid.

General additional information

Main indication: query chylothorax.

If cloudy after centrifugation, inspection for chylomicrons may be required.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

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Volume - Child 1

​0.2 mL

Additive - Child 1

​None

Volume - Adult 1

​0.2 mL

Additive - Adult 1

​None

Chloride (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is currently unaccredited to ISO 15189 for fluid analysis.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

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Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

Calcium (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is currently unaccredited to ISO 15189 for fluid analysis.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

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Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

Amylase (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is accredited to ISO 15189 for peritoneal and drain fluid.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.
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Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

Albumin (fluid)

Anticipated turnaround

1 day

Static information/disclaimer

This test is accredited to ISO 15189 for pleural and peritoneal fluid.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines for interpretation of fluid biochemistry and indication for testing.

 

Container_Adult1
Container_Child1
Volume - Child 1

​0.1 mL

Additive - Child 1

​None

Volume - Adult 1

​0.1 mL

Additive - Adult 1

​None

α-Fetoprotein (AFP, fluid)

Anticipated turnaround

4 days

Static information/disclaimer

This test is currently unaccredited to ISO 15189 for fluid analysis.

General additional information

All fluids must be centrifuged and then analysed only if free from particles.

Please see the ACBI guidelines ‘The biochemistry of body fluids’ for interpretation of fluid biochemistry and indication for testing.

Container_Adult1
Container_Child1
Volume - Child 1

​0.4 mL

Additive - Child 1

​None

Volume - Adult 1

0.4 mL

Additive - Adult 1

​None

Throat swab for culture for pharyngitis

Transport arrangements

​Transport as soon as practicable.

Sample storage arrangements

If delay in transporting, store in fridge (4-6°C).

Special instructions for collection

Useful if:

  • Patient is part of an outbreak as notified by Health Protection Team
  • Patient is a healthcare worker or in regular contact with vulnerable individuals such as the immunocompromised, the comorbid, or those with compromised skin integrity
  • Patient is treated with an antibiotic other than a penicillin or cephalosporin. (Locally in children approximately 90% and in adults 80% of Strep pyogenes are sensitive to clarithromycin/ azithromycin. )
  • Treatment failure and recurrent/persistent tonsillitis
  • Quinsy
  • Penicillin allergy
  • Tonsillitis with rash
  • Clinical suspicion of Diphtheria


Please let us know about the following information as it may alter specimen processing:
• Treatment failure and recurrent tonsillitis, or tonsillitis with rash – we will look for Arcanobacterium haemolyticum.
• Persistent sore throat or Quinsy – we will look for Fusobacterium necrophorum.

If your patient has any of the following clinical details, please contact the Duty Microbiologist as it influences sampling, and which tests will be carried out on samples.

Testing for Corynebacterium species (C. diphtheriae and C. ulcerans, the causative agents of diphtheria) will be carried out on samples from patients where any of the following clinical details are provided.  

• Membranous or pseudomembranous pharyngitis/tonsillitis 
• Contact with a confirmed case of diphtheria within the last 10 days 
• Travel abroad (or contact with anyone who has travelled) to a high risk area for diphtheria within the last 10 days 
• Contact with any animals (including household pets, visiting a farm or petting zoo) within the last 10 days 
• Recent consumption of any type of unpasteurised milk or dairy products 
• Patient works in a clinical microbiology laboratory, or similar occupation, where Corynebacterium species may be handled.

How to request

GP order comms, or via Trak ("C&S - Swabs" and change site to "Swab, throat"), or request form.

Availability

Samples are processed between 0900-2000 (RIE) and 0900-1700 (SJH). Samples taken outwith these hours will be processed the following morning.

Anticipated turnaround

​Up to 5 days.

What happens if the result is positive or abnormal

Result will automatically appear on TRAK and may be telephoned to originating location if required.

General additional information

Please let us know about the following information as it may alter specimen processing:

  • Treatment failure and recurrent tonsillitis, or tonsillitis with rash – we will look for Arcanobacterium haemolyticum
  • Persistent sore throat or Quinsy – we will look for Fusobacterium necrophorum.
  • Please indicate in the clinical details if Diphtheria testing is required.

Diphtheria

Classic respiratory Diphtheria is now rare in the UK and no longer easily recognised. Mild respiratory cases resemble Streptococcal pharyngitis and classical pseudomembrane may not develop, particularly in vaccinated individuals.

Diphtheria is a clinical and public health emergency. A strong clinical suspicion of infection needs urgent secondary care referral. Please indicate in the clinical details if Diphtheria testing is required.

Indications for testing a throat swab for Diphtheria

  • Membranous or pseudomembranous pharyngitis/tonsillitis
  • Contact with a confirmed case of diphtheria within the last 10 days
  • Travel abroad (or contact with anyone who has travelled) to a high-risk area for diphtheria within the last 10 days
  • Recent consumption of any type of unpasteurised milk or dairy products
  • Occupational exposure through working in a laboratory where Corynebacterium species may be handled
  • Exposure to unwell animals with ulcers that might be cutaneous diphtheria
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Neonatal Rapid QF-PCR (Blood)

Transport arrangements

​Courier. Taxi

Sample storage arrangements

​Fridge.

How to request

​Referral form available from Laboratory main website

Anticipated turnaround

​3d

What happens if the result is positive or abnormal

​Result reported to referring clinician

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Volume - Child 1

​1-2ml

Platelet Nucleotides

Special instructions for collection
Sample tubes are provided directly from the Specialist Haemostasis Laboratory. Contact the Laboratory on 0131 242 6837

 

How to request

​Must be discussed and arranged with Haematology medical staff.

Availability

​Wednesday 09:00 - 13:00

For alternative times, contact the laboratory for special arrangement.
Anticipated turnaround

21 days

What happens if the result is positive or abnormal

​Results are not phoned. This test is only available by direct requesting from Haematology medical staff.

Static information/disclaimer

​​This test is not accredited to ISO15189 at the Royal Infirmary of Edinburgh.

Volume - Adult 1

​Tubes are provided within the Haemophilia centre.

Beta 2- Glycoprotein IgM

Transport arrangements

​Specimen must be transported within a plastic sealable bag or other suitable container. Samples should be transported to the laboratory ASAP

Special instructions for collection

​The coagulation samples (green top) MUST be filled to the green line indicated on the tube.

How to request

​This tests is only availble by special arrangement with the Haeamatology medical staff.

Availability

​Monday - Friday: routine service 9:00 - 17:00. Test not available during restricted service.

Anticipated turnaround

​10 days

Volume - Adult 1

​3ml - fill to line

Additive - Adult 1

​Sodium Citrate

Beta 2- Glycoprotein IgG

Transport arrangements

​Specimen must be transported within a plastic sealable bag or other suitable container. Samples should be transported to the laboratory ASAP

Sample storage arrangements

​​

Special instructions for collection

​The coagulation samples (green top) MUST be filled to the green line indicated on the tube.

How to request

​This tests is only availble by special arrangement with the Haeamatology medical staff.

Availability

​Monday - Friday: routine service 9:00 - 17:00. Test not available during restricted service.

Anticipated turnaround

​10 days

Volume - Adult 1

​3ml - fill to line.

Additive - Adult 1

​Citrate

Hepatitis Delta Serology

Transport arrangements

​Ambient temperature via porter, courier, Royal Mail or DX. Compliant with IATA packing instruction 650

Sample storage arrangements

​If processing is delayed, refrigeration is preferable to storage at ambient temperature. Delays of over 48 h are undesirable

Special instructions for collection

Minimum volume of sample: 1 mL

Specimen type: Venous blood or serum​​

4.7 mL clotted blood tube or 1 mL serum

Availability

​Monday - Friday

Anticipated turnaround

10 days

General additional information

​Specific information: HBsAg status

Factors known to significantly affect the results: Haemolysis

Clinical information: This test is only performed on patients who are HBsAg positive and if a patient is found to be delta antibody positive the sample is referred for Hepatitis Delta virus PCR to determine viraemia status.

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Volume - Adult 1

​4.7 ml

Volume - Adult 2

1.0 ml

HCV Resistance

Sample storage arrangements

​Plasma should be stored at 4°C and dispatched as soon as possible

Special instructions for collection

Minimum volume: 1ml

​Stored frozen plasma (1ml) at -20oC or lower

How to request

​All requests must be emailed to loth.bbvsequencing@nhslothian.scot.nhs.uk to discuss prior to sending of samples.

Availability

​Monday - Friday

Anticipated turnaround

10 days

General additional information

Special precautions: Haemolysed specimens can be inhibitory

Clinical information
Testing may be indicated at baseline and treatment failure depending on the DAA regimen

HCV resistance testing is only performed when there is evidence of treatment failure on direct acting agents and where it is helpful to select future HCV treatment options

All samples tested should be genotype 1a HCV with viral load >100,000 IU/ml

For tests requested on samples already held in the NHS Lothian laboratory email loth.bbvsequencing@nhslothian.scot.nhs.uk

 

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Volume - Adult 1

​Clean molecular grade 2 ml vial

HCV Genotyping

Special instructions for collection

Minimum volume: 1ml​

Stored frozen plasma (1ml) at -20oC or lower

How to request

​​HCV genotyping is only carried out if there is evidence of ongoing HCV viraemia

Availability

​Monday - Friday

Anticipated turnaround

10 days

General additional information

​Clinical information: HCV viral load of sample being sent and current HCV risk status

Special precautions: Haemolysed specimens can be inhibitory

For tests requested on samples already held in the NHS Lothian Laboratory email loth.bbvsequencing@nhslothian.scot.nhs.uk

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Volume - Adult 1

​Clean molecular grade 2 ml vial

HIV Tropism

Transport arrangements

​Blood to arrive at the laboratory within 4 hours of being drawn and not later than 4 pm to allow time for processing.

Special instructions for collection
Minimum volume: 6ml
 
Freshly drawn whole blood in EDTA
 
Collection container (including preservatives): CE marked leak proof container
How to request

Prior to sending, contact lab to discuss.

Availability

​Monday - Friday

Anticipated turnaround

​14 days

General additional information

​​​Clinical information: Ensure request form is completed in full as genotypic tropism determination is based on a bioinformatic tool that requires the data requested to produce a satisfactory result

Special precautions: Transport should not be delayed, samples will not be accepted

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Volume - Adult 1

​6 ml

HIV Resistance

Transport arrangements

​Ambient temperature via courier or DX. Compliant with IATA packing instruction 650

Special instructions for collection

Minimum volume: 1ml​

Stored frozen plasma (1ml) at -20oC or lower

Availability

​Monday - Friday

Anticipated turnaround

10 days

General additional information

Clinical information: Complete treatment history of the patient, results of previous tests if carried out elsewhere, viral load if carried out elsewhere.

If tests are requested on stored samples already held in the NHS Lothian Laboratory requests should be emailed to loth.bbvsequencing@nhslothian.scot.nhs.uk
 
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Volume - Adult 1

Clean molecular grade 2 ml vial

HIV Avidity

Transport arrangements

​Ambient temperature via porter, courier, Royal Mail or DX. Compliant with IATA packing instruction 650

Sample storage arrangements

​If processing is delayed, refrigeration is preferable to storage at ambient temperature. Delays of over 48 h are undesirable.

Special instructions for collection

Minimum volume of sample: 0.5 mL

Specimen type: Venous blood or serum​

4.7 mL clotted blood tube or 0.5 mL serum from clotted blood

How to request

This test is only performed on new HIV diagnoses and not on transfers of care. Note this test will be carried out automatically on samples from new diagnoses confirmed in Lothian

Availability

​Monday - Friday

Anticipated turnaround

30 days

Static information/disclaimer

​This test is not currently accredited to ISO15189.

General additional information

Clinical Information: Baseline HIV viral load should be provided.

Factors known to significantly affect the results: Haemolysis

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Volume - Adult 1

​4.7 mL

HIV Confirmation

Transport arrangements

​Ambient temperature via porter, courier, Royal Mail or DX. Compliant with IATA packing instruction 650

Sample storage arrangements

​If processing is delayed, refrigeration is preferable to storage at ambient temperature. Delays of over 48 h are undesirable

Special instructions for collection

​4.7 mL clotted blood tube or 1ml serum (small sterile container)

Availability

​Monday-Friday.

Anticipated turnaround

​2 days

General additional information

Specific information: Initial screening results with index and type of assay used including manufacturer

Factors known to significantly affect the results: Haemolysis
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Volume - Adult 1

​4.7 ml

Vitamin B6

Sample storage arrangements

Protect sample from light.

Special instructions for collection

Fasting sample or 8 hours after supplementation is recommended.

Anticipated turnaround

​28 days

General additional information
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Volume - Child 1

​2.0 mL

Additive - Child 1

​Lithium heparin

Volume - Adult 1

​2.0 mL

Volume - Adult 2

​2.0 mL

Additive - Adult 1

​Lithium heparin (non gel)

Additive - Adult 2

​Potassium EDTA

Vitamin B2

Sample storage arrangements

Protect sample from light.

Special instructions for collection

Fasting sample or 8 hours after supplementation is recommended.

Anticipated turnaround

​28 days

General additional information
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Container_Adult2
Container_Child1
Volume - Child 1

​2 mL

Volume - Adult 1

​2 mL

Volume - Adult 2

​2 mL

Additive - Adult 1

​Lithium heparin (non gel)

Additive - Adult 2

​Potassium EDTA

IDH1 and IDH2 mutation analysis

Transport arrangements

​Referral specimens should be sent directly to Molecular Pathology at the above address (see transport recommendations). For patients with pathology specimens held within NHS Lothian there is no need to arrange transport of specimens.

How to request

Testing for NHS Lothian patients can be requested by email to molecular.pathology@nhslothian.scot.nhs.uk. Referral requests must be accompanied by a completed request form.

 
 
Please also refer to our detailed requesting instructions.
Availability

​​Monday - Friday. 09:00 – 17:00

Anticipated turnaround

​​An integrated Molecular Pathology report should be available within 10 working days. See results.

Static information/disclaimer

The pyrosequencing test is accredited to ISO 15189.  This NGS test is also accredited to ISO 15189:2012.

Please note: alternative methodologies may be used. Full details will be included in all reports.

 
General additional information
​The 2016 World Health Organisation Classification of Tumours of the Central Nervous System (CNS) requires the classification of CNS tumours using a broad range of molecular tests; accurate classification is essential for selection of appropriate treatment modalities. Detection of mutations in IDH1 and IDH2 assists the differential diagnosis of gliomas and provides key diagnostic and prognostic information: IDH mutation status is a definitive marker of secondary glioblastoma; astrocytomas and oligodendrogliomas can contain mutations in IDH1 or IDH2, whereas other CNS tumours usually do not contain these mutations.
 

IDH1 and IDH2 mutation analysis is carried out by NGSand pyrosequencing. The pyrosequencing assay detects and differentiates 5 different “hot spot” mutations within IDH1 and 6 different mutations within the IDH2 gene.  These regions account for 99.7% of reported mutations in the IDH1 and IDH2 genes.  For further details of the NGS assay, including regions assessed, click here.  

For clinical advice on appropriate investigations, please contact our Molecular Pathology team.

 

ROS1 gene rearrangement

Transport arrangements

Referral specimens should be sent directly to Molecular Pathology at the above address (see transport recommendations). For patients with pathology specimens held within NHS Lothian there is no need to arrange transport of specimens.

How to request

ROS1 gene rearrangement analysis can be requested individually or as part of the lung cancer panel.

Testing for NHS Lothian patients can be requested by email to molecular.pathology@nhslothian.scot.nhs.uk. Referral requests must be accompanied by a completed request form.
 
 
 
Please also refer to our detailed requesting instructions.
Availability

Monday - Friday. 09:00 – 17:00

Anticipated turnaround

An integrated Molecular Pathology report should be available within 10 working days. See results.

Static information/disclaimer

ROS1 FISH is accredited to ISO15189.

ROS1 Immunohistochemistry is not currently accredited to ISO15189.

Please note: alternative methodologies may be used. Full details will be included in all reports.

General additional information
​The ROS proto-oncogene 1, receptor tyrosine kinase, encoded by the ROS1 gene, is structurally similar to the anaplastic lymphoma kinase (ALK) protein. ROS1 gene rearrangements involving a range of fusion partners have been described in 1-2% of non-small cell lung cancers, resulting in abnormal expression of the ROS1 protein. The presence of ROS1 gene rearrangement predicts response to the same classes of tyrosine kinase inhibitors used to treat ALK-positive lung cancers.

Immunohistochemistry is carried out to detect aberrant ROS1 protein expression using the D4D6 clone (Cell Signaling). ROS1 gene rearrangement analysis is carried out by fluorescence in-situ hybridization (FISH).

Analysis of the ROS1 gene is carried out as part of the lung cancer testing panel, which also includes EGFR and KRAS mutation analysis, PD-L1 expression and detection of ALK gene rearrangments.

For clinical advice on appropriate investigations, please contact our Molecular Pathology team.

β-d-glucan

Transport arrangements

​​As soon as practicable

Sample storage arrangements

​Refrigerate at 4 to 6 degrees

How to request

By request form.

Availability

​This is a referred test so should be sent Monday-Friday 9am-5pm.

Anticipated turnaround

​14 days

General additional information

This test is sent to the Mycology Reference Laboratory in Manchester. EDTA bloods are NOT suitable

Guidance on use of fungal antigen tests is available from IDSA

https://academic.oup.com/cid/article/63/4/e1/2595039

For chronic pulmonary forms of aspergillosis, Aspergillus antibodies are used instead of galactomannan and β-D-glucan tests. These tests are available from the Immunology laboratory.

For chronic cavitary pulmonary aspergillosis and aspergilloma, request Aspergillus IgG antibody test:

https://www.edinburghlabmed.co.uk/TestDirectory/Pages/Display.aspx?tID=4590

For allergic bronchopulmonary aspergillosis (ABPA), request Aspergillus IgE antibody and total IgE tests:

https://www.edinburghlabmed.co.uk/TestDirectory/Pages/Display.aspx?tID=4589

Serum and BAL galactomannan is recommended as an accurate marker for the diagnosis of Invasive Aspergillosis  (IA)  in adult and paediatric patients when used in certain patient subpopulations (haematologic malignancy, HSCT) (strong recommendation; high-quality evidence).

Galactomannan is not recommended for routine blood screening in patients receiving mould-active antifungal therapy or prophylaxis, but can be applied to bronchoscopy specimens from those patients (strong recommendation; high-quality evidence).

Where patients not on mould – active therapy are being screened, samples should be tested twice a week. Galactomannan is not recommended for screening in SOT recipients or patients with CGD (strong recommendation; high-quality evidence).

Serial monitoring of serum galactomannan can be used in the appropriate patient subpopulations (haematologic malignancy, HSCT) who have an elevated galactomannan at baseline, to monitor disease progression and therapeutic response, and predict outcome (strong recommendation; moderate-quality evidence).

Serum assays for β-D-glucan are recommended for diagnosing IA in high-risk patients (haematologic malignancy, allogeneic HSCT), but are not specific for Aspergillus (strong recommendation; moderate-quality evidence)

β-D-glucan has not been extensively studied in IA to predict outcome (weak recommendation; low-quality evidence

Endocarditis   Galactomannan and β-D-glucan tests may be used for diagnosis of invasive fungal infections such as endocarditis. Please discuss such cases with a Medical Microbiologist before ordering the test.

Pneumocystis pneumonia   β-D-glucan may be used for confirming the diagnosis of Pneumocystis pneumonia when pulmonary samples are not available. Please discuss such cases with a Medical Microbiologist before ordering the test.

Severe influenza infection   Patients with severe influenza are at increased risk for IA. Consider galactomannan testing of BAL in patients with influenza admitted to critical care. Serum galactomannan testing is also indicated but is less sensitive. A negative galactomannan result does not exclude IA. β-D-glucan testing of serum is a sensitive but non-specific test for invasive fungal infection, positive β-D-glucan tests unrelated to fungal infection are more likely during the first few days on the ICU and in patients with sepsis or receiving blood products or immunoglobulin therapy.

Please see current PHE guidance at:  https://www.gov.uk/government/publications/seasonal-influenza-managing-cases-in-critical-care-units

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Volume - Child 1

5ml

Volume - Child 2

5ml 

Volume - Child 3

Bronchoalveolar lavage fluid

Volume - Adult 1

​5ml

Volume - Adult 2

​5ml

Volume - Adult 3

Bronchoalveolar lavage fluid

Cytomegalovirus Avidity

Transport arrangements
Inter-site van shuttle service, GP van service, External hospital van service, Couriers, Hospital porter collection (refer to collection times posted in wards / departments), Hospital Pneumatic Tube System (PTS)
Sample storage arrangements
Specimen transport arrangements must be in accordance with current postal and transport regulations. Samples should be transported to the laboratory without delay. If processing is delayed, refrigeration at 2-8 oC is preferable to storage at room temperature for all samples, with the exception of EDTA blood samples. EDTA blood samples must be stored at room temperature (19-23 oC). Patient samples can be transported at ambient temperature.
Special instructions for collection
Specimen transport arrangements must be in accordance with current postal and transport regulations. Samples should be transported to the laboratory without delay. If processing is delayed, refrigeration at 2-8 oC is preferable to storage at room temperature for all samples, with the exception of EDTA blood samples. EDTA blood samples must be stored at room temperature (19-23 oC). Patient samples can be transported at ambient temperature.
How to request
​This is not a test that can be requested by user. This test is done as part of CMV diagnostic algorithm, often on stored samples in the Laboratory. Please contact Virology to request testing virology.advice@nhslothian.scot.nhs.uk
Availability
​Weekdays 08.30 - 17.00
Anticipated turnaround
​5 days
What happens if the result is positive or abnormal
Low avidity samples in Pregnant women would be phoned to relevant obstetrician. Referring hospital would be contacted with low avidity result to ensure clinical context is understood.
Static information/disclaimer

​False negative results may occur for a variety of reasons including: inappropriate timing of sample collection, inappropriate sample type, inappropriate sample storage and presence of virus below the detectable limit of the assay. New and emerging variants may also occur which may not be detected by specific assays. Towards the limit of detection of an assay sampling variation will result in lower reproducibility. Haemolysed or lipaemic samples can also cause interference with assay results.

General additional information
​Please contact virologyadvice@nhslothian.scot.nhs.uk for all non-urgent clinical enquiries.
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Volume - Child 1

​1-2ml

Volume - Adult 1

​4.9ml

PNH Screen

Transport arrangements

​Sample MUST be received within 48 hours of collection

Sample storage arrangements

​Room Temperature

How to request

​TRAK/Request Form

Availability

​Monday-Friday (Samples must arrive by 3PM on a Friday)

Anticipated turnaround

​14 days

What happens if the result is positive or abnormal

​Requesting clinician will be contacted via telephone or email. Please ensure details are included on request.

Static information/disclaimer

This test is not currently accredited to ISO 15189:2012

Additive - Adult 1

​EDTA

CD4/CD8 Counts

Transport arrangements

​Sample MUST be received within 48 hours of collection

Sample storage arrangements

​Room Temperature

How to request

​TRAK/Request Form

Availability

Samples are batched Tuesday-Friday afternoons.  Samples MUST arrive in WGH immunophenotyping laboratory by 1pm on a Friday to ensure appropriate processing.

Anticipated turnaround

​48 Hours

What happens if the result is positive or abnormal

​Requesting clinician will be contacted via telephone or email. Please ensure details are included on request.

Static information/disclaimer

This test is accredited to ISO 15189:2012

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Volume - Adult 1

​2.7ml Peripheral blood

Additive - Adult 1

​EDTA

CD19 Count

Transport arrangements

​Sample MUST be received within 48 hours of collection

Sample storage arrangements

​Room Temperature

How to request

Request Form

Availability

Samples are batched Tuesday-Friday afternoons.  Samples MUST arrive in WGH immunophenotyping laboratory by 1pm on a Friday to ensure appropriate processing.

Anticipated turnaround

​48 Hours

Static information/disclaimer

This test is accredited to ISO 15189:2012

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Volume - Adult 1

2.7 ml Peripheral blood

Additive - Adult 1

​EDTA

Lymphocyte Subsets

Transport arrangements

​Sample MUST be received within 48 hours of collection

Sample storage arrangements

​Room Temperature

How to request

​TRAK/Request Form

Availability

Samples are batched Tuesday-Friday afternoons.  Samples MUST arrive in WGH immunophenotyping laboratory by 1pm on a Friday to ensure appropriate processing.

Anticipated turnaround

​48 Hours

What happens if the result is positive or abnormal

​Requesting clinician will be contacted via telephone or email. Please ensure details are included on request.

Static information/disclaimer

This test is accredited to ISO 15189:2012

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Volume - Adult 1

​2.7ml Peripheral blood

Additive - Adult 1

​EDTA

Lymphoid Panel

Transport arrangements

Sample MUST be received within 48 hours of collection

Sample storage arrangements

​Room Temperature

How to request

​Request form

Availability

​Monday-Friday (Samples must arrive by 3PM on a Friday)

Anticipated turnaround

​14 days

What happens if the result is positive or abnormal

​Requesting clinician will be contacted via telephone or email if requested. Please ensure details are included on request form.

Static information/disclaimer

This test is accredited to ISO 15189:2012

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Volume - Adult 1

​4-5ml Bone marrow

Volume - Adult 2

​2.7 ml Peripheral blood

Volume - Adult 3

​2ml Minimum volume (CSF, Pleural or Ascitic Fluid)

Additive - Adult 1

​EDTA

Additive - Adult 2

​EDTA

Additive - Adult 3

​No additive

Acute Leukaemia Panel

Transport arrangements

​Sample MUST be received within 48 hours of collection

Sample storage arrangements

​Room Temperature

How to request

​Request form

Availability

​Monday-Friday (Samples must arrive by 3PM on a Friday)

Anticipated turnaround

​14 days

What happens if the result is positive or abnormal

​Requesting clinician will be contacted via telephone or email. Please ensure details are included on request form.

Static information/disclaimer

This test is accredited to ISO 15189:2012

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Volume - Adult 1

​4-5ml Bone marrow

Volume - Adult 2

​2.7ml Peripheral blood

Additive - Adult 1

​EDTA

Additive - Adult 2

​EDTA

Kleihauer

Transport arrangements
​No special transport arrangements are required. If part of an Rh programme / suitability testing, a sample from the baby should be sent at the same time.
Sample storage arrangements
​Stored at 4°;c
Special instructions for collection

​If part of an Rh programme / Suitability testing, the maternal sample should be taken after a period of 40 minutes post delivery to allow the feotal red cells to be fully distributed within the maternal circulation. If a Group and Save is also required, two maternal samples must be sent as the sample intended for Kleihauer testing cannot be centrifuged.

 

NHS Lothian operates a Zero Tolerance approach in relation to blood sample acceptance criteria. Errors in patient identification and sample labelling may lead to ABO-incompatible transfusions.

The demographics on the samples MUST be hand written, legible and MUST match exactly to the accompanying request form. Samples labelled with an addressograph or where evidence of an addressograph have been attached will be discarded. Samples with errors or where patient core identifiers have been obliterated will be discarded.

Sample Labelling

The following patient identifying data and sampler signature is mandatory -

  • CHI number (or Hospital Number where no CHI number is available - See CHI exceptions)*
  • Surname
  • Forename
  • Date of Birth
  • Signature

Sample Labelling for Unknown Patients

  • Surname / Forename = UNKNOWN
  • Temporary Identification Number = beginning with 700
  • Gender
  • Sample dated and signed

Once patients details become known, a new sample must be sent to the laboratory

Request Form Labelling

Addressograph labels are acceptable for request forms. If the form is handwritten then the information must be clear, legible and MUST contain the following data identifiers -

  • Surname
  • Forename
  • Date of Birth
  • CHI Number (See CHI exceptions)*
  • Name and signature of the person taking the sample
  • Name of the requesting clinician. (For component requests, this is the Doctor or authorised Nurse that has prescribed the transfusion)
  • Clinical details are desirable but are not essential

*CHI Exceptions

Not all patients will have a CHI number. If the patient is a genuine CHI exception then the Hospital number is acceptable and MUST be used. A CHI number may not be available in the following circumstances -

  • Foreign visitors
  • Patients from England, Wales and Ireland
  • Patients not registered with a GP in Scotland
  • Patients currently remanded within Her Majesty's Prisons
  • Patients in the armed forces
  • Newborn infants <3 days old.

A MINIMUM of 2.0ml of blood is required for adult specimens. For paediatric patients, please refer to the link below for specimen types and volume ranges.

 

 

 

How to request

​Electronic ordering is not available for Blood Transfusion tests. All tests are ordered via request form which must then be sent to the laboratory along with the appropriate sample(s).

Request forms can be obtained from the Blood Transfusion Laboratory.

Availability

Tests can be received 24/7 into the blood sciences / Blood Transfusion laboratory

Anticipated turnaround
​Maximum of 72 hours
What happens if the result is positive or abnormal

​The amount of Anti-D Immunoglobulin required post FMH is dependant upon the volume of foetal red cells determined to be present in the maternal circulation. The number of foetal and maternal cells are counted and reported as < or > 2mls.

FMH of >2mL are forwarded to SNBTS Gartnavel for confirmation by Flow Cytometry. If the FMH is >4.0mL, a second sample will be requested at 72 hours post IM administration of Anti-D Immunoglobulin or 48 hours post IV administration.

If a patient is discharged before the result of the Kleihauer is available then a standard dose of Anti-D can be issued. If further anti-D is required, the clinical team will be contacted.

 

General additional information
  • ​False positive results may be obtained where a woman has a high level of foetal haemoglobin (HbF).

  • Decisions made regarding the dosage of Anti-D Ig required in cases of massive Feto-Maternal Haemorrhage should be made once the result has been confirmed by Flow Cytometry.

  • Seperate samples should be received for maternal blood grouping / antibody screening and Kleihauer testing.

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Container_Child1
Volume - Child 1

​4.5mL

Additive - Child 1

​EDTA

Volume - Adult 1

4.5ml

Additive - Adult 1

​EDTA

NPM1

Transport arrangements

Specimens should ideally arrive within 24 hours of collection (maximum of 48 hours) and should be sent to the following address:

Western General Hospital

Haematology/Biochemistry Combined Reception

Immunophenotyping Laboratory

Crewe Road

Edinburgh

EH4 2XU​

 

See also Specimen transportation.

Sample storage arrangements

Samples should be stored at room temperature. See specimen requirements.​

How to request

Please refer to our detailed requesting ​instructions.  The HMDS request form can be located here.​

 

Availability

​Monday-Friday 9am-5pm

Anticipated turnaround

Results should be expected within 3 working days.  See results.

Static information/disclaimer

Identification of the presence of an NPM1 mutation is accredited to ISO15189. 

Characterisation of the NPM1 mutation by Sanger sequencing is accredited to ISO15189. However, part of this procedure now makes use of an automated pipetting system which has been separately validated but is not currently accredited to ISO 15189.

General additional information

NPM1 gene mutation analysis performed for all patients diagnosed with AML based on immunophenotyping results via a reflex testing strategy.


Mutation in the NPM1 gene is observed in approximately 30% of AML cases and is frequently associated with a normal karyotype. The presence of an NPM1 mutation in the absence of a FLT3 internal tandem duplication  is associated with a more favourable prognosis in AML.


FLT3 (ITD and D835) mutation detection is also available for AML patients at diagnosis. 


For patients carrying an NPM1 mutation for whom molecular monitoring will be required, identification of the mutation type will be determined by next generation sequencing or Sanger sequencing.


Molecular monitoring for NPM1 positive AML is available for types A, B & D.

For NPM1 MRD monitoring, refer to the separate entry in the test directory, found here


For clinical advice on appropriate investigations and advice for the interpretation of test results, please contact us.

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Volume - Adult 1

2 x 9ml peripheral blood, bone marrow specimen or FFPE tissue.

Total volume required is 10-15mL.  Sample tube can be any size as long as it is EDTA anti-coagulated.

Additive - Adult 1

​EDTA

FLT3

Transport arrangements

Specimens should ideally arrive within 24 hours of collection (maximum of 48 hours) and should be sent to the following address:

Western General Hospital

Haematology/ Biochemistry Combined Reception

Immunophenotyping Laboratory

Crewe Road

Edinburgh

EH4 2XU​

See also Specimen transportation.​

Sample storage arrangements

Samples should be stored at room temperature. See specimen requirements.

How to request

Please refer to our detailed requesting ​instructions.  The HMDS request form can be located here.​ 

 

Testing may be performed by reflex from immunophenotyping.

Availability

​Monday-Friday 9am-5pm

Anticipated turnaround

Results should be expected within 3 working days. See results.

Static information/disclaimer

This test is accredited to ISO 15189:2012

General additional information

FLT3 (both ITD and point mutation D835) gene mutation analysis performed for all patients diagnosed with AML based on immunophenotyping results via a reflex testing strategy.  

FLT3 mutation is not a reliable marker for MRD monitoring within AML

FLT3 is the most commonly mutated gene in AML and detected in one third of AML cases. Internal tandem duplications (ITDs) in the juxtamembrane domain of FLT3 are seen in 25% of AML cases, while others show mutations in the tyrosine kinase domain of FLT3 gene.

Where FLT3 ITD mutation detected, the mutant allele ratio of the ITD mutation can be calculated. The presence of a high level of FLT3 ITD mutation in the absence of a NPM1 mutation is associated with an adverse prognosis in AML.

NPM1 mutation detection​ is also available for AML patients at diagnosis.

For clinical advice on appropriate investigations and advice for the interpretation of test results, please contact us​.​

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Volume - Adult 1

2 x 9ml peripheral blood, bone marrow specimen or FFPE tissue.

Total volume required is 10-15mL.  Sample tube can be any size as long as it is EDTA anti-coagulated

Additive - Adult 1

​EDTA

MYD88 p.L265P Mutation testing

Transport arrangements

Blood and bone marrow specimens should ideally arrive within 24 hours of collection (maximum of 48 hours).  There is no time limit for FFPE samples.  Samples should be sent to the following address:

Western General Hospital

Haematology/Biochemistry Combined Reception

Immunophenotyping Laboratory

Crewe Road

Edinburgh

EH4 2XU​

 

See also Specimen transportation.

Sample storage arrangements

Samples should be stored at room temperature. See specimen requirements.​

How to request

Please refer to our detailed requesting ​instructions.  The HMDS request form can be located here.​

 

Requests for testing FFPE tissue should be sent to the Molecular Pathology Service at RIE with a completed HMDS test request form. 

Availability

​Monday-Friday 9am-5pm

Anticipated turnaround

Results should be expected within 10 working days.  See results.

Static information/disclaimer

All sample with a CLL score <2 via Immunophenotyping will be tested for MYD88 p.L265P mutations via a reflex testing strategy

General additional information

This test uses an allele specific real time PCR for the identification of the MYD88 p.L265P variant to help aid in the differentiation of low grade B Cell lymphoplasmacytic lymphoma (LPL), Waldenström Macroglobulinaemia (WM) and IgM monoclonal gammopathy of undetermined significance (MGUS) from marginal zone lymphomas. The MYD88 p.L265P mutation can also be used to distinguish the different sub-types of diffuse large B cell lyphomas (DLBCL); the L265P mutation being found in activated B cell like DLBCL, but rarely in the germinal centre like DLBCL. See testing.

This test is accredited to ISO 15189:2012

For clinical advice on appropriate investigations and advice for the interpretation of test results, please see contact us​.

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Volume - Adult 1

​5ml peripheral blood, bone marrow specimen or FFPE tissue

Additive - Adult 1

​EDTA

MRD monitoring TCF3::PBX1

Transport arrangements

Blood and bone marrow specimens should ideally arrive within 24 hours of collection (maximum of 48 hours).  Specimens should arrive no later than 3.30pm on Friday.  Samples should be sent to the following address:

Western General Hospital

Haematology/Biochemistry Combined Reception

Immunophenotyping Laboratory

Crewe Road

Edinburgh

EH4 2XU​

 

See also Specimen transportation.

Sample storage arrangements

Samples should be stored at room temperature. See specimen requirements.

How to request

Please refer to our detailed requesting ​instructions.  The HMDS request form can be located here.​

 

Availability

​Monday-Friday 9am-5pm

Anticipated turnaround

Results should be expected within 10 working days.  See results.

Static information/disclaimer

This test is accredited to ISO 15189:2012

General additional information

This assay is for MRD monitoring and only suitable if the TCF1::PBX1 fusion has previously been detected.

Please see ALL panel testing for diagnostic samples.

For clinical advice on appropriate investigations and advice for the interpretation of test results, please contact us​.

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Volume - Adult 1

​10-15ml Peripheral blood or bone marrow specimen

Additive - Adult 1

​EDTA

MRD monitoring ETV6::RUNX1

Transport arrangements

Blood and bone marrow specimens should ideally arrive within 24 hours of collection (maximum of 48 hours).  Specimens should arrive no later than 3.30pm on Friday.  Samples should be sent to the following address:

Western General Hospital

Haematology/Biochemistry Combined Reception

Immunophenotyping Laboratory

Crewe Road

Edinburgh

EH4 2XU​

 

See also Specimen transportation.

Sample storage arrangements

Samples should be stored at room temperature. See specimen requirements.

How to request

Please refer to our detailed requesting ​instructions.  The HMDS request form can be located here.

 

Availability

​Monday-Friday 9am-5pm

Anticipated turnaround

Results should be expected within 10 working days. See results.

Static information/disclaimer

This test is accredited to ISO 15189:2012

General additional information

This assay is for MRD monitoring and only suitable if the ETV6::RUNX1 fusion has previously been detected.

Please see ALL panel testing for diagnostic samples.

For clinical advice on appropriate investigations and advice for the interpretation of test results, please contact us.​

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Volume - Adult 1

​10-15ml Peripheral blood or bone marrow specimen

Additive - Adult 1

​EDTA

MRD monitoring CBFB::MYH11

Transport arrangements

Blood and bone marrow specimens should ideally arrive within 24 hours of collection (maximum of 48 hours).  Specimens should arrive no later than 3.30pm on Friday.  Samples should be sent to the following address:

Western General Hospital

Haematology/Biochemistry Combined Reception

Immunophenotyping Laboratory

Crewe Road

Edinburgh

EH4 2XU​

 

See also Specimen transportation.

Sample storage arrangements

Samples should be stored at ​room temperature. See specimen requirements.

How to request

​Please refer to our detailed requesting instructions. The HMDS request form can be located here.

 

Availability

​Monday-Friday 9am-5pm

Anticipated turnaround

Results should be expected within 10 working days. See results.

Static information/disclaimer

This test is accredited to ISO 15189:2012

General additional information

This assay is for MRD monitoring and only suitable if the CBFB::MYH11 fusion has previously been detected.

Please see AML panel testing for diagnostic samples.

For clinical advice on appropriate investigations and advice for the interpretation of test results, please contact us​.

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Volume - Adult 1

​10-15ml Peripheral blood or bone marrow specimen

Additive - Adult 1

​EDTA

MRD monitoring PML::RARA

Transport arrangements

Blood and bone marrow specimens should ideally arrive within 24 hours of collection (maximum of 48 hours).  Specimens should arrive no later than 3.30pm on Friday.  Samples should be sent to the following address:

Western General Hospital

Haematology/Biochemistry Combined Reception

Immunophenotyping Laboratory

Crewe Road

Edinburgh

EH4 2XU​

 

See also Specimen transportation.

Sample storage arrangements

Samples should be stored at room temperature. See specimen requirements.

How to request

Please refer to our detailed requesting instructions. The HMDS request form can be located here.

 

Availability

​Monday-Friday 9am-5pm

Anticipated turnaround

Results should be expected within 10 working days. See results.

Static information/disclaimer

This test is accredited to ISO 15189:2012

General additional information

This assay is for MRD monitoring and only suitable if the PML::RARA fusion has previously been detected.

Please see AML panel testing for diagnostic samples.

For clinical advice on appropriate investigations and advice for the interpretation of test results, please contact us.

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Volume - Adult 1

​10-15ml Peripheral blood or bone marrow specimen

Additive - Adult 1

​EDTA

ZnT8

How to request

​Trak, ICE, Clinical Immunology request form.

Diabetic screen tests can only be requested via Hospital referrals.

Availability

​Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround

​21 Days

 

General additional information

ZNT8 is a major autoantigen in development of autoimmunity against pancreatic β-cells leading to type 1 diabetes (T1D) in children and young adults (Wenzlau et al., 2007). A high amount of ZNT8 autoantibodies are frequently detected in the early stage of T1D. With disease progression, ZNT8 autoantibody titers drop significantly.

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

MRD monitoring RUNX1::RUNXT1

Transport arrangements

Blood and bone marrow specimens should ideally arrive within 24 hours of collection (maximum of 48 hours).  Specimens should arrive no later than 3.30pm on Friday.  Samples should be sent to the following address:

Western General Hospital

Haematology/Biochemistry Combined Reception

Immunophenotyping Laboratory

Crewe Road

Edinburgh

EH4 2XU

See also Specimen transportation.​

Sample storage arrangements

Samples should be stored at room temperature. See specimen requirements.​

How to request

Please refer to our detailed requesting ​instructions.  The HMDS request form can be located here.​

 

Availability

​Monday - Friday 9am-5pm

Anticipated turnaround

​Results should be expected within 10 working days.  See results.

Static information/disclaimer

This test is accredited to ISO 15189:2012

General additional information

This assay is for MRD monitoring and only suitable if the RUNX1::RUNX1T1 fusion has previously been detected.

Please see AML panel testing for diagnostic samples.

For clinical advice on appropriate investigations and advice for the interpretation of test results, please contact us

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Volume - Adult 1

​12 ml Peripheral blood or bone marrow specimen

Additive - Adult 1

​EDTA

TP53 mutation analysis

Transport arrangements

Fresh (peripheral blood / bone marrow aspirate) samples should ideally arrive within 24 hours of collection (maximum of 48 hours) and should be sent to the following address:


Western General Hospital
Haematology/Biochemistry Combined Reception
Immunophenotyping Laboratory
Crewe Road
Edinburgh
EH4 2XU


See also Specimen transportation.

FFPE specimens should sent directly to Molecular Pathology at the following address (see transport recommendations).

Molecular Pathology
Department of Laboratory Medicine
Royal Infirmary of Edinburgh
51 Little France Crescent
Old Dalkeith Road
Edinburgh
EH16 4SA

For patients with pathology specimens held within NHS Lothian there is no need to arrange transport of specimens.
If DNA has already been extracted from FFPE specimens, this may be sent to Molecular Pathology/HMDS at the WGH site.

Sample storage arrangements

Samples should be store at room temperature. See specimen requirements.

How to request

For Blood and Bone marrow samples: 

please refer to our detailed requesting instructions. The HMDS request form can be located here.

For FFPE samples: 

Testing for NHS Lothian patients can be requested by email to molecular.pathoogy@nhslothian.scot.nhs.uk.

Referral requests must be accompanied by a completed request form.

Please also refer to our detailed requesting instructions.

 

Availability

​Monday-Friday 9am-5pm

Anticipated turnaround

For Blood and bone marrow samples [CLL], results should be expected within 15 working days. See results.

For FFPE samples, an integrated Molecular Pathology report should be available within 10 working days. See results.

What happens if the result is positive or abnormal

​Requesting clinician will be contacted via telephone or email. Please ensure details are included on request form.

Static information/disclaimer

This test has been accredited to ISO15189. However, part of the procedure now makes use of an automated pipetting system which has been separately validated but is not currently accredited to ISO 15189.

General additional information

For assessment of TP53 loss (del17p) by FISH, please refer to the South East Scotland Cytogenetics Service.

CLL samples contain a mixture of leukaemia and non-leukaemia cells.  Since TP53 mutations are acquired within leukaemia cells, they will not be present within non-CLL cells within the sample. Therefore, it is important to be aware of the approximate percentage of leukaemia cells within the sample. The assay carries a limit of detection of 15% and therefore a low level TP53 mutation may not be detected by this approach.

For samples with a likely low level leukaemia percentage, Lymphoprep isolation of mononuclear cells will be performed. Hence, please inform the laboratory, where possible, of the total lymphocyte count and total white cell count in the sample

​TP53 mutation assessment is performed using Sanger sequencing to assess and identify sequence variants in exons 2a, 2d, 3, 4b, 5, 6, 7, 8, 10 and 11 of the TP53 gene (LRG_321 specific exon numbering). In most cases, a TP53 mutation is associated with loss of chromosome 17p [del17p]. However, some patients may carry a TP53 mutation without accompanying loss of chromosome 17p. Mutations in the TP53 gene are associated with chemotherapy resistance and poor prognosis in patients with CLL.

Assessment of the IGHV mutation status can also be performed.

For clinical advice on appropriate investigations and advice for the interpretation of test results, please contact us​.

Assessment of TP53 by Sanger sequencing is available for patients with endometrial carcinoma and to aid the diagnosis of high grade serous ovarian carcinoma. Where necessary, this may be supplemented by the use of next generation sequencing. Refer to Molecular Pathology Testing for further details

 

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Volume - Adult 1

2 x 2.7ml peripheral blood or bone marrow specimen

Additive - Adult 1

​EDTA

Nutritional screen

General additional information

​Nutritional / micronutrient screen includes: copper, manganese, selenium, zinc and vitamins A, B1, B2, B6, E.

Please send 2x lithium heparin NON GEL tubes (or special trace metal tubes) to perform the full screen.

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Legionella Spp

Transport arrangements

​Inter -site van shuttle service, GP van service, External Hospital van service, Couriers, Hospital porter collection, (refer to collection times posted in wards / departments), Hospital Pneumatic Tube System (PTS).

Sample storage arrangements

​Specimen transport arrangements must be in accordance with current postal and transport regulations. Samples should be transported to the laboratory without delay. If processing is delayed, refrigeration at 2 - 8 oC is preferrable to storage at room temperature. Patient samples can be transported at ambient temperature.

Special instructions for collection

​Clinical samples must be collected into leak-proof containers and placed into a sealed bag with absorbant material. Patient samples must be individually packaged and not mixed with other patient samples. Any appropriate hazard labelling should be clearly visible on the sample bag / sample.

How to request

​Use appropriate Virology Request Form or TRAK referral letter. Forms must be fully completed with Patient Identifier Number (CHI), Forename, Surname, Date of Birth, Gender and Location of patient (hospital and ward or primary care centre).

Availability

​Weekdays 08.30 - 17.00

Weekends 09.00 - 16.00

Anticipated turnaround

​2 days

What happens if the result is positive or abnormal

​Positive results are notified to the Duty Bacteriologist to inform relevant team and are available in the patient's records.

General additional information

​Test is available 7 days per week. Same day results are available when sample is received into the laboratory by 09.00.

Please contact virologyadvice@nhslothian.scot.nhs.uk for all non-urgent clinical enquiries.

Volume - Child 1

​2 mls

Additive - Child 1

​Sputum to be taken into sterile universal container

Volume - Adult 1

​2 mls

Additive - Adult 1

​Sputum to be taken into sterile universal container

Chlamydia Spp (Respiratory)

Transport arrangements

​Inter-site van shuttle service, GP van service, External hospital van service, Couriers, Hospital porter collection (refer to collection times posted in wards / departments), Hospital Pneumatic Tube System (PTS).

Sample storage arrangements

​Specimen transport arrangements must be in accordance with current postal and transport regulations. Samples should be transported to the laboratory without delay. If processing is delayed, refrigeration at 2-8 oC is preferable to storage at room temperature. Patient samples can be transported at ambient temperature.

Special instructions for collection

​Clinical samples must be collected into leak-proof containers and placed into a sealed bag with absorbant material. Patient samples must be individually packaged and not mixed with other patient samples. Any appropriate hazard labelling should be clearly visible on the sample bag / sample.

How to request

NHS Lothian users: Use appropriate TRAK or ICE barcode labels which include Patient Identifier Number (CHI), Forename, Surname, Date of Birth, Gender and Location of patient (hospital and ward or primary care centre). 

Use specific request form only if TRAK or ICE ordering system is unavailable.

 

 

Users outside NHS Lothian, use NPEx or request form:

 

 

 

Availability

​Weekdays 08.30 - 17.00

Weekends 09.00 - 16.00

Anticipated turnaround

​2 days

What happens if the result is positive or abnormal

NHS Lothian- Duty Microbiologist will contact the clinical team to discuss the result and any infection control related issues where appropriate.​

Users outside NHS Lothian- result released by the BMS to local Clinical Microbiology Team for action.

All positive results are confirmed by PCR and sequencing to determine Chlamydia Spp.

General additional information

​Test available 7 days per week. Same day results available when sample is received into the laboratory by 09.00.

Please contact loth.molmicro@nhs.scot for all non-urgent clinical enquiries.

Volume - Child 1

​2 mls

Additive - Child 1

Nasopharyngeal Secretions taken into Conical Centrifuge Tube

Volume - Adult 1

​2 mls

Additive - Adult 1

​Sputum to be taken into sterile universal container

Mycoplasma genitalium or Ureaplasma spp

Transport arrangements

Mycoplasma genitalium is a sexually transmitted infection that is often asymptomatic. In a minority of people, it can cause dysuria, discharge, itch, pain and bleeding. Urogenital Ureaplasma colonisation or infection is usually asymptomatic there is no testing available. 

Transport as soon as is practicable.

Sample storage arrangements

If delay in transporting, store in the fridge (4-6°C).

Special instructions for collection

High vaginal swabs – Send to RIE Molecular lab for M. genitalium PCR; must be swab in CT / GC Transport Medium (not VTM or charcoal/gel swab) - no other Mycoplasma spp/Ureaplasma spp testing is possible in Scotland, or at national reference laboratory, on genital samples.


Urine – Do not send for testing from females – not possible to test anywhere. Mycoplasma genitalium testing from male urines only by RIE Molecular lab.


Neonate respiratory samples – Send neat sample to UKHSA Colindale for M. hominis/Ureaplasma spp PCR


Sterile site fluids e.g. pelvic abscess fluid – Send neat sample to GOSH for 16S which will pick up Mycoplasma/Ureaplasma spp plus any other bacteria present. If Mycoplasma/Ureaplasma specifically sought ONLY in a sterile site fluid – discuss with UKHSA Colindale ref lab.

How to request

Via Trak ("Mycoplasma genitalium PCR"), or by request form. 

Availability

Monday - Friday 0900-1700 (RIE)

Anticipated turnaround

Up to 7 working days

What happens if the result is positive or abnormal

​All positive samples are referred to Scottish STI Reference Laboratory (based at the RIE) for determination of antibiotic resistance by sequencing.

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Container_Child1
Volume - Child 1

​As adult

Volume - Child 2

​As adult

Additive - Child 2

​as adult

Volume - Adult 1

​> 0.5 ml ​Urine (for males only)

Volume - Adult 2

​Vaginal swab in Chlamydia/Gonorrhoea medium (for females)

Additive - Adult 2

​Liquid included in container should be retained

Metadrenaline /metanephrine (plasma)

Transport arrangements

UNSTABLE HORMONES: Bloods should be placed on ice and transported to the laboratory immediately.

Special instructions for collection

Patient preparation: Ideally patients should be seated or supine (30minutes) prior to sampling. Dietary catecholamine intake has little effect on metanephrine and normetanephrine but may have significant impact on 3-methoxytyramine. Overnight fasting and avoidance of catcholamine rich foods (eg bananas, plums, pineapples, walnuts, tomatoes, avocados, aubergine, alcoholic drinks, vinegar) is advised if measurement of 2-methoxytyramine is likely to be important as a marker of dopamine secretion.

How to request

​Please notify the laboratory prior to sample collection.

Availability

​Normal working hours only.

Anticipated turnaround

Please see Glasgow website for details.

General additional information

Plasma Metanephrine includes normetanephrine, metanephrine and 3-methoxytyramine. A local assay for 24 hour Urinary Metadrenaline is available and for most patients this should be requested in the first instance. Urinary and plasma metadrenalines have similar specificity and sensitivity for phaeochromocytoma.

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Container_Child1
Volume - Adult 1

​2.7 mL

Acquired FISH (PETS)

Transport arrangements

​Courier or Taxi or pre-arranged drop off

Sample storage arrangements

Fridge

How to request

​Referral form from laboratory main website

Availability

​Mon-Fri

Anticipated turnaround

​10-28d

What happens if the result is positive or abnormal

​All reports sent to referring clinician

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Leptospira serology and PCR

Transport arrangements

Useful: This test is performed at the Rare and Imported Pathogens laboratory (RIPL). They provide a panel of testing based on geography of travel and clinical symptoms so it is imperative these are provided at the time of requesting, otherwise these samples will not be processed. Unless you have a specific reason for testing for a single agent like Leptospirosis, or are very familiar with current disease prevalence, we suggest that you provide as many clinical and travel details as possible and allow RIPL to select the appropriate panel of tests. 

​Transport as soon as is practicable.

Sample storage arrangements

If delay in transporting, store in the fridge (4-6°C).

Special instructions for collection
If the sample is taken within 7 days of symptom onset, Leptospira PCR can be done on the same serology sample.
 
You can also request a Leptospira PCR on a urine sample in a universal container (not Boric acid) up to 21 days after symptom onset, though it must be accompanied by a serum/clotted blood sample (in a brown tube). EDTA blood (red tube) is not required for Leptospira PCR.
How to request

Via Trak ("Microbiology serology") then specify in clinical details re: Leptospirosis serology and PCR, or by  request form. Ensure date of onset of symptoms, travel details and dates and clinical symptoms are supplied in the request.

Availability

Monday - Friday 0900-1700 (RIE). Will be processed and sent to reference lab.

Anticipated turnaround

From receipt in RIPL: PCR - 5 working days. Serology - 7 working days. Microscopic agglutination test - 12 working days.

What happens if the result is positive or abnormal

​A report will be issued. The result may be telephoned or e-mailed if clinically appropriate.

General additional information

Note that Leptospirosis testing will always be performed routinely on returning travellers where travel and clinical details compatible with Leptospirosis are provided to RIPL. Therefore, for returning travellers, it is not necessary to submit a Leptospirosis request form in addition to the standard RIPL request form (P1). For further information please refer to the RIPL Manual.

Container_Adult1
Container_Child1
Volume - Child 1

​1 - 2 mls

Volume - Adult 1

​4.9 mls

Galactomannan

Transport arrangements

​As soon as practicable

Sample storage arrangements

Refrigerated at 4 to 6 degrees

How to request

​Via TRAK, request form or GP order comms

Availability

This is a referred test so should be sent Monday - Friday 9am to 5 pm.

Anticipated turnaround

​14 days.

General additional information

This test is sent to the Mycology Reference Laboratory in Manchester. EDTA bloods are NOT suitable.

Guidance on use of  fungal antigen tests is available from IDSA:  

https://academic.oup.com/cid/article/63/4/e1/2595039

For chronic pulmonary forms of aspergillosis, Aspergillus antibodies are used instead of galactomannan and β-D-glucan tests. These tests are available from the Immunology laboratory.

For chronic cavitary pulmonary aspergillosis and aspergilloma, request Aspergillus IgG antibody test:

https://www.edinburghlabmed.co.uk/TestDirectory/Pages/Display.aspx?tID=4590

For allergic bronchopulmonary aspergillosis (ABPA), request Aspergillus IgE antibody and total IgE tests:

https://www.edinburghlabmed.co.uk/TestDirectory/Pages/Display.aspx?tID=4589

Serum and BAL galactomannan is recommended as an accurate marker for the diagnosis of Invasive Aspergillosis  (IA)  in adult and paediatric patients when used in certain patient subpopulations (haematologic malignancy, HSCT) (strong recommendation; high-quality evidence).

Galactomannan is not recommended for routine blood screening in patients receiving mould-active antifungal therapy or prophylaxis, but can be applied to bronchoscopy specimens from those patients (strong recommendation; high-quality evidence).

Where patients not on mould – active therapy are being screened, samples should be tested twice a week. Galactomannan is not recommended for screening in SOT recipients or patients with CGD (strong recommendation; high-quality evidence).

Serial monitoring of serum galactomannan can be used in the appropriate patient subpopulations (haematologic malignancy, HSCT) who have an elevated galactomannan at baseline, to monitor disease progression and therapeutic response, and predict outcome (strong recommendation; moderate-quality evidence).

Serum assays for β-D-glucan are recommended for diagnosing IA in high-risk patients (haematologic malignancy, allogeneic HSCT), but are not specific for Aspergillus (strong recommendation; moderate-quality evidence)

β-D-glucan has not been extensively studied in IA to predict outcome (weak recommendation; low-quality evidence

Endocarditis   Galactomannan and β-D-glucan tests may be used for diagnosis of invasive fungal infections such as endocarditis. Please discuss such cases with a Medical Microbiologist before ordering the test.

Pneumocystis pneumonia   β-D-glucan may be used for confirming the diagnosis of Pneumocystis pneumonia when pulmonary samples are not available. Please discuss such cases with a Medical Microbiologist before ordering the test.

Severe influenza infection   Patients with severe influenza are at increased risk for IA. Consider galactomannan testing of BAL in patients with influenza admitted to critical care. Serum galactomannan testing is also indicated but is less sensitive. A negative galactomannan result does not exclude IA. β-D-glucan testing of serum is a sensitive but non-specific test for invasive fungal infection, positive β-D-glucan tests unrelated to fungal infection are more likely during the first few days on the ICU and in patients with sepsis or receiving blood products or immunoglobulin therapy.

Please see current PHE guidance at:   

https://www.gov.uk/government/publications/seasonal-influenza-managing-cases-in-critical-care-units

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Volume - Child 1

5ml

Volume - Child 2

5ml

Volume - Child 3

Bronchoalveolar lavage fluid

Volume - Adult 1

5ml

Volume - Adult 2

​5ml

Volume - Adult 3

Bronchoalveolar lavage fluid

Adalimumab and antibody level

How to request

​Please send a completed 'Adalimumab Therapeutic Monitoring Request' form to the laboratory to ensure processing.

Anticipated turnaround

​21 days

General additional information

​An antidrug antibody level will be provided with the drug level.

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Infliximab and antibody level

How to request

Please send a completed 'Infliximab Therapeutic Monitoring Request' form to the laboratory to ensure processing.

Anticipated turnaround

​21 days

General additional information

​An antidrug antibody level will be provided with the drug level.

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Borrelia Serology

Transport arrangements

​No Special Requirements

Sample storage arrangements

​​No Special Requirements

Special instructions for collection

​On the rare occasions where investigation of CSF for Lyme disease is required there must be a paired serum and CSF sample taken on the same day to allow comparison of antibody levels. The sample must not be bloody. Please also send CSF for cell counts and protein and glucose. Please send at least 1 ml of CSF to Bacteriology.

How to request

Test can be orderd on TRAK or ICE or by form

Availability

Lyme antibodies are not detectable before 3 weeks post exposure and may take up to 10 weeks post exposure to develop.

Patients who present with symptoms consistent with Lyme disease (excluding recognised erythema migrans, see below) or non-specific symptoms after tick bite/exposure should be tested.

In order to avoid inappropriate testing which can lead to false positive results and poor management of patients, the following testing criteria are suggested by the Scottish Lyme Disease and Tick-borne Infections Laboratory (SLDTRL).

The following samples should NOT be tested:

1) No clinical details – results for samples with no clinical details cannot be interpreted.


2) Asymptomatic tick bite/ tick bite only – seek medical advice if become symptomatic.


3) Post treatment - monitor clinically. Serology cannot be used to assess treatment success.


4) Erythema migrans- treat empirically (as per NICE Guidelines). If there is doubt about the presentation of erythema migrans, please refer a serum sample for testing. Some clinicians are not familiar with the presentation of the rash and in these cases serology may be useful.

Anticipated turnaround

​3 Weeks

What happens if the result is positive or abnormal

​Patients with positive results from an NHS laboratory can be treated if uncomplicated Lyme disease. Complicated patients such as those requiring IV therapy for Lyme disease, or positive results from a non-NHS laboratory, or query chronic Lyme disease can be referred to the Regional Infectious Diseases Unit (RIDU, WGH) for advice on management.

General additional information

The SLDTRL Handbook is available on the Link below.

There is also useful guidance on the PHE website
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TB Quantiferon Gold 4 tube Assay

Transport arrangements

Utility: Quantiferon Gold is an interferon gamma release assay​. They are only useful to identify latent (non-active) TB infection. IGRAs measure interferon gamma released from sensitised cells on exposure to PPD. They are a measure of prior infection with MTB. They are more sensitive than the TB skin test as they are specific to certain antigens so don't respond to previous BCG vaccination or most non-tuberculous mycobacteria.

However it can't:

  • Rule in active TB (not specific enough)
  • Rule out active TB (not sensitive enough)
  • Differentiate between active and latent infection (positive in both)
  • Risk stratify likelihood of developing active TB in latent infection
  • Be used to assess treatment

Please see Respiratory TB Guidance for further information.

 Inter-site van shuttle service, GP van service, External hospital van service, Couriers, Hospital porter collection (refer to collection times posted in wards / departments), Hospital Pneumatic Tube System (PTS)

Sample storage arrangements

​Specimen transport arrangements must be in accordance with current postal and transport regulations. Samples should be transported to the laboratory without delay. If processing is delayed, store at room temperature. Patient samples can be transported at ambient temperature. Samples must be received into the lab within 16 hours of being taken. 

When samples are taken at Western General Hospital (WGH) or St John's Hospital (SJH), please deliver samples directly to your local laboratory where they will be incubated and then transferred to the Royal Infirmary of Edinburgh (RIE).

Special instructions for collection

​To order tubes via PECOS the product number is 622222.

Gently invert each tube 10 times. Samples should reach laboratory within 16 hours of being taken. Alternatively, samples should be incubated upright at 37oC +- 1 for 16-24 hours. After incubation, samples may be held between 4 and 27oC for up to 3 days prior to centrifugation.

Clinical samples must be collected into leak-proof containers and placed into a sealed bag with absorbent material. Patient samples must be individually packaged and not mixed with other patient samples. Any appropriate hazard labelling should be clearly visible on the sample bag / sample.

How to request

Via Trak ("Quantiferon Gold") or by request form. Forms must be fully completed with Patient Identifier Number (CHI), Forename, Surname, Date of Birth, Gender and Location of patient (hospital and ward or primary care centre).

Availability

Samples can be received into the Blood Sciences lab on any NHS Lothian site, which are open 24/7. They will then be transported to the testing site after the samples have been stabilised for processing.

Anticipated turnaround

​10 days

What happens if the result is positive or abnormal

Positive results are notified to the TB Bacteriologist and are available in the patient’s records.

Static information/disclaimer

​False negative results may occur for a variety of reasons including: inappropriate timing of sample collection, inappropriate sample type, inappropriate sample storage and incorrect volume of blood in each Quantiferon collection tube. New and emerging variants may also occur which may not be detected by specific assays. Towards the limit of detection of an assay sampling variation will result in lower reproducibility. Haemolysed or lipaemic samples can also cause interference with assay results.

General additional information

Only indicated for diagnosis of latent TB infection.

Please contact loth.microbiologyoffice@nhslothian.scot.nhs.uk for all non-urgent clinical enquiries.
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Volume - Child 1

​0.8 -1.0 ml

Volume - Adult 1

​0.8 - 1.0 ml

Everolimus

Special instructions for collection

​Collect sample just before next dose.

Anticipated turnaround

​<28 days.

General additional information

​Available by prior arrangement with the laboratory only.

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Volume - Child 1

​1 mL

Additive - Child 1

​Potassium EDTA

Volume - Adult 1

​1 mL

Additive - Adult 1

​Potassium EDTA

Anti-Mullerian hormone (AMH)

How to request

​Paper request form

Availability

​Test run twice per week in batches.

Anticipated turnaround

​<5 days

General additional information

​Test available for certain patient groups only, by prior arrangement with the laboratory.

For further information on the potential for biotin interference please click here.

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Volume - Child 1

​0.5 mL

Additive - Child 1

​Lithium-heparin

Volume - Adult 1

​0.5 mL

Volume - Adult 2

​0.5 mL

Additive - Adult 1

​None

Additive - Adult 2

​Lithium-heparin

Apixaban Assay

Transport arrangements

Specimen must be transported within a plastic sealable bag or other suitable container. Samples should be transported to the laboratory ASAP

Special instructions for collection

The coagulation samples (green top) MUST be filled to the green line indicated on the tube.

How to request

Request form or Trak. Note: this assay must be arranged through Haematology medical staff.

Availability

Monday - Friday: routine service 09:00 - 17:00. Saturday - Sunday: routine service 09:00 - 13:00

Please contact the laboratory for urgent samples outside of routine hours.

Anticipated turnaround

​1 day

What happens if the result is positive or abnormal

The laboratory will telephone abnormal results where it appears that these are likely to be clinically significant. Please provide telelphone/ bleep number.

Static information/disclaimer

This test is currently unaccredited by UKAS

General additional information

This assay must be arranged through the Haematology medical team. The results will be returned to the Haematology medical team for interpretation.

Additive - Child 1

​Sodium citrate

Additive - Adult 1

​Sodium citrate

Familial amyloid polyneuropathy

Transport arrangements

​Lab van or 1st class post

Sample storage arrangements

Refrigerate - DO NOT FREEZE. For additional sample packaging and transport information see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

Anticipated turnaround
Static information/disclaimer

This test is currently unaccredited to ISO 15189. 

General additional information

For referral criteria and gene list please see SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

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Volume - Child 1

1ml

Volume - Child 2

1ml

Volume - Adult 1

3ml

Volume - Adult 2

3ml

Factor XIII Deficiency Genetic Testing

Transport arrangements

​Lab van or 1st class post

Sample storage arrangements

Refrigerate - DO NOT FREEZE. For additional sample packaging and transport information see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

How to request

Molecular Haematology request form available via

https://services.nhslothian.scot/geneticservice/request-forms/

Anticipated turnaround
Static information/disclaimer

This test is currently unaccredited to ISO 15189. 

General additional information

For referral criteria and gene list please see SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

 

Volume - Child 2

1ml

Volume - Adult 1

Volume - Adult 2

3ml

Coagulation & Fibrinolysis Genetic testing

Transport arrangements

​Lab van or 1st class post

Sample storage arrangements

Refrigerate - DO NOT FREEZE. For additional sample packaging and transport information see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

 

How to request

Molecular Haematology request form available via https://services.nhslothian.scot/geneticservice/request-forms/

Anticipated turnaround
Static information/disclaimer

This test is currently unaccredited to ISO 15189. 

General additional information

For referral criteria and gene list please see SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

An information sheet is also available for this test: https://services.nhslothian.scot/geneticservice/molecular-genetic-test-information-sheets/

Volume - Child 2

1ml

Volume - Adult 1

​​​

Volume - Adult 2

3ml

Bernard-Soulier Syndrome Genetic Testing

Transport arrangements

​Lab van or 1st class post

Sample storage arrangements

Refrigerate - DO NOT FREEZE. For additional sample packaging and transport information see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

How to request

Molecular Haematology request form available via https://services.nhslothian.scot/geneticservice/request-forms/

Anticipated turnaround
Static information/disclaimer

This test is currently unaccredited to ISO 15189. 

General additional information

For referral criteria and gene list please see SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

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Volume - Child 1

1ml

Volume - Child 2

1ml

Volume - Adult 1

3ml​

Volume - Adult 2

3ml

NT-proBNP

Availability

​Normal working hours only.

Anticipated turnaround

2 weeks

General additional information

​The use of this test is currently being piloted in NHS Lothian by the heart failure team. Please note that NT-proBNP requests will only be processed during this pilot period if they have been authorised by the heart failure team. For any queries, please contact the Duty Biochemist to discuss.

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Volume - Adult 1

0.5 mL

Volume - Adult 2

0.5 mL

Volume - Adult 3

0.5 mL

Additive - Adult 1

​None

Additive - Adult 2

​Lithium-heparin

Additive - Adult 3

​Potassium-EDTA

EMA Binding

How to request

​Must be discussed and arranged with Haematology medical staff. Contact the Haematology Registrar on bleep #6466

Anticipated turnaround

​48 hours

What happens if the result is positive or abnormal

​Results are not phoned.

General additional information

​​This test is not accredited to ISO15189 at the Royal Infirmary of Edinburgh.

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Volume - Child 1

​1mL

Additive - Child 1

​EDTA

Volume - Adult 1

​2 x tubes, each with >1.5mls

Additive - Adult 1

​EDTA

PD-L1 immunohistochemistry

Transport arrangements

​Referral specimens should be sent directly to Molecular Pathology at the above address (see transport recommendations). For patients with pathology specimens held within NHS Lothian there is no need to arrange transport of specimens.

How to request

​​​EGFR mutation analysis can be requested individually or as part of the lung cancer panel.

 
Testing for NHS Lothian patients can be requested by email to molecular.pathology@nhslothian.scot.nhs.uk.
 

Referral requests must be accompanied by a completed 

 
PD-L1 immunohistochemistry has not been fully validated for use on cytology specimens. Biopsy material is preferred, however FNA specimens may be used if they are received fixed in formalin. Cytology specimens fixed in CytoLyt are not suitable for PD-L1 immunohistochemistry.
 
Please also refer to our detailed requesting instructions.
Availability

​​​Monday - Friday. 09:00 – 17:00

Anticipated turnaround

​​​An integrated Molecular Pathology report should be available within 14 days. See results.

Static information/disclaimer

This test is accredited to ISO 15189.

Please note: alternative methodologies may be used. Full details will be included in all reports.

General additional information

​Programmed death 1 (PD-1) is an immune inhibitory receptor that is widely expressed by cells of the immune system, especially cytotoxic T lymphocytes. Upregulation of the ligand PD-L1 prevents T-cell activation and contributes the evasion of tumour cells from immune recognition. Immune checkpoint inhibitors such as nivolumab and pembrolizumab are monoclonal antibody therapies that target PD-1 on the patient’s T-cells, thereby blocking PD-1/PD-L1 interaction and preventing tumour cells from inactivating the local cytotoxic T-cell response.

Upregulation of PD-L1 expression in tumour cells is demonstrated by immunohistochemistry. The resulting tumour percentage score (TPS) is used to estimate the likelihood of a patient’s tumour responding to first line pembrolizumab therapy.

Analysis of PD-L1 expression is carried out as an extension to the lung cancer testing panel, which also includes EGFR and KRAS mutation and ALK and ROS1 gene rearrangement analysis.

For clinical advice on appropriate investigations, please contact our Immunohistochemistry team 0131 242 7167.

EGFR mutation analysis (blood)

Transport arrangements

​Referral specimens should be sent directly to Molecular Pathology at the above address (see transport recommendations). Please be aware that blood samples for cfDNA analysis must not be refrigerated and that any tube other than those specified above cannot be accepted for analysis.

Appropriate tubes, request forms and instructions for collection are available on request.

How to request

​All requestors, both internal and external to NHS Lothian, will need to provide a completed request form for cfDNA analysis.

 

Please note that this test is primarily for EGFR mutation analysis for confirmation of TKI resistance mutations but may also be requested where biopsy is not possible. For EGFR mutation analysis for stratification of patients for first line EGFR tyrosine kinase inhibitor therapy, please see EGFR mutation analysis (FFPE).

Please also refer to our detailed requesting instructions.
Availability

​Monday - Friday. 09:00 – 17:00

Anticipated turnaround

​An integrated Molecular Pathology report should be available within 5 working days. See results.

Static information/disclaimer

This test is accredited to ISO 15189:2012

Please note, alternative methodologies may be used. Full details will be included in all reports.

General additional information

​Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are currently used as first line treatment for patients with advanced metastatic non-small cell lung cancer (NSCLC). Somatic mutations in exons 18 to 21 of the EGFR gene are used to predict response to EGFR TKI therapy.

Often following a period of EGFR TKI therapy, patients will relapse as a result of emergence of mutations conferring resistance, in particular a c.2369C>T p.T790M mutation in exon 20 of the EGFR gene. Patients whose tumours harbour this T790M mutation are eligible for treatment with the third-generation TKI osimertinib and a change in therapeutic strategy may be indicated. Although biopsy remains the preferred material for EGFR mutation analysis, it is possible to detect mutations in cell-free tumour DNA (cfDNA) extracted from peripheral blood; but with reduced sensitivity. Due to the lower sensitivity a negative result cannot exclude the presence of a mutation and a biopsy is strongly recommended if clinically appropriate.

Molecular Pathology use the COBAS® EGFR mutation kit (Roche Diagnostics), which can detect 41 mutations in exons 18-21 of the EGFR gene: 30 deletions and complex mutations in exon 19; c.2369C>T p.(Thr790Met); c.2303G>T p.(Ser768Ile); c.2573T>G or c.2573_2574delTGinsGT p.(Leu858Arg); c.2155G>A p.(Gly719Ser); c.2156G>C p.(Gly719Ala); c.2155G>T p.(Gly719Cys); and 4 insertions in exon 20. The assay detects 86.7% of known mutations in exons 18 to 21 as listed in the Catalogue of Somatic Mutations in Cancer.

EGFR mutation analysis (of FFPE tissue samples) is also carried out as part of the lung cancer testing panel, which also includes KRAS mutation analysis, PD-L1 expression and detection of ALK and ROS1 gene rearrangements.

 
For clinical advice on appropriate investigations, please contact our Molecular Pathology team.
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​2 x 8.5ml 

Antenatal Haemoglobinopathy Screen

Transport arrangements

Specimen must be transported within a plastic sealable bag or other suitable container. Sample MUST be recieved within 24 hours of collection

Special instructions for collection

A Full Blood Count is always performed alongside the Haemoglobinopathy screen.

How to request

​The Family Origin Questionairre (FOQ) form MUST be completed

Availability

Monday - Friday: routine service 09:00 - 17:00. Test not available during restricted service.

Anticipated turnaround

5 days

What happens if the result is positive or abnormal

The Laboratory will inform the Foetal Medicine Midwives any abnormal results, for approriate follow-up.

General additional information

Blood transfusion may make interpretation unreliable. If a haemoglobinopathy cannot be characterised then further studies may be undertaken.

This assay detects the presence of the abnormal haemoglobins, HbC, HbD, HbE, HbS and other rarer variants. The quantitation will be reported as appropriate. ​

Volume - Adult 1

>1.5ml

BK PCR

Transport arrangements
Inter-site van shuttle service, GP van service, External hospital van service, Couriers, Hospital porter collection (refer to collection times posted in wards / departments), Hospital Pneumatic Tube System (PTS)
 
Sample storage arrangements

Specimen transport arrangements must be in accordance with current postal and transport regulations. Samples should be transported to the laboratory without delay. If processing is delayed, refrigeration at 2-8 oC is preferable to storage at room temperature for all samples, with the exception of EDTA blood samples. EDTA blood samples must be stored at room temperature (19-23 oC). Patient samples can be transported at ambient temperature

Special instructions for collection

​Specimen transport arrangements must be in accordance with current postal and transport regulations. Samples should be transported to the laboratory without delay. If processing is delayed, refrigeration at 2-8 oc is preferable to storage at room temperature for all samples, with the exception of EDTA blood samples. EDTA blood samples must be stored at room temperature (19-23 oC). Patient samples can be transported at ambient temperature.

How to request

Use appropriate TRAK or ICE barcode labels which include Patient Identifier Number (CHI), Forename, Surname, Date of Birth, Gender and Location of patient (hospital and ward or primary care centre). Use Virology Request Form only if TRAK or ICE ordering system is unavailable.

Availability

Weekdays 08.30 - 17.00
 
Anticipated turnaround

7 days

What happens if the result is positive or abnormal

​Result authorised in Apex; significant results phoned by Duty Virologist

Static information/disclaimer

​False negative results may occur for a variety of reasons including: inappropriate timing of sample collection, inappropriate sample type, inappropriate sample storage and presence of virus below the detectable limit of the assay. New and emerging variants may also occur which may not be detected by specific assays. Towards the limit of detection of an assay sampling variation will result in lower reproducibility. Haemolysed or lipaemic samples can also cause interference with assay results.
 

General additional information

Please contact virologyadvice@nhslothian.scot.nhs.uk for all non-urgent clinical enquiries.

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Volume - Child 1

​1-2mls

Seasonal Corona Virus PCR (OC43, HKU1, NL63, 229E)

Transport arrangements

Inter-site van shuttle service, GP van service, External hospital van service, Couriers, Hospital porter collection (refer to collection times posted in wards / departments), Hospital Pneumatic Tube System (PTS)

Sample storage arrangements

​Specimen transport arrangements must be in accordance with current postal and transport regulations. Samples should be transported to the laboratory without delay. If processing is delayed, refrigeration at 2-8 oC is preferable to storage at room temperature for all samples, with the exception of EDTA blood samples. EDTA blood samples must be stored at room temperature (19-23 oC). Patient samples can be transported at ambient temperature.

Special instructions for collection

​Clinical samples must be collected into leak-proof containers and placed into a sealed bag with absorbent material. Patient samples must be individually packaged and not mixed with other patient samples. Any appropriate hazard labelling should be clearly visible on the sample bag / sample.

How to request

se appropriate TRAK or ICE barcode labels which include Patient Identifier Number (CHI), Forename, Surname, Date of Birth, Gender and Location of patient (hospital and ward or primary care centre). Use Virology Request Form only if TRAK or ICE ordering system is unavailable.

Availability

​Test carried out once per week on selected populations of patients

Anticipated turnaround

​8 days

What happens if the result is positive or abnormal

Positive results are notified to the Duty Virologist and are available in the patient’s records.

Static information/disclaimer

​False negative results may occur for a variety of reasons including: inappropriate timing of sample collection, inappropriate sample type, inappropriate sample storage and presence of virus below the detectable limit of the assay. New and emerging variants may also occur which may not be detected by specific assays. Towards the limit of detection of an assay sampling variation will result in lower reproducibility. Haemolysed or lipaemic samples can also cause interference with assay results.

General additional information

Please contact virologyadvice@nhslothian.scot.nhs.uk for all non-urgent clinical enquiries.

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Volume - Child 1

​Throat swab

Preferred sample

Volume - Child 2
Bronchoalveolar lavage taken into a 20ml Sterile Universal Conainer
Volume - Child 3
​Nasopharyngeal Secretions taken into Conical Centrifuge Tube

Parvovirus B19 PCR

Transport arrangements
Inter-site van shuttle service, GP van service, External hospital van service, Couriers, Hospital porter collection (refer to collection times posted in wards / departments), Hospital Pneumatic Tube System (PTS)
Sample storage arrangements

Specimen transport arrangements must be in accordance with current postal and transport regulations. Samples should be transported to the laboratory without delay. If processing is delayed, refrigeration at 2-8 oC is preferable to storage at room temperature for all samples, with the exception of EDTA blood samples. EDTA blood samples must be stored at room temperature (19-23 oC). Patient samples can be transported at ambient temperature.

Special instructions for collection

​Clinical samples must be collected into leak-proof containers and placed into a sealed bag with absorbent material. Patient samples must be individually packaged and not mixed with other patient samples. Any appropriate hazard labelling should be clearly visible on the sample bag / sample.

How to request

Use appropriate TRAK or ICE barcode labels which include Patient Identifier Number (CHI), Forename, Surname, Date of Birth, Gender and Location of patient (hospital and ward or primary care centre). Use Virology Request Form only if TRAK or ICE ordering system is unavailable.

Availability
Weekdays 08.30 - 17.00
 
Weekends 9.00 - 16.00
Anticipated turnaround

​7 days

What happens if the result is positive or abnormal

Positive results are notified to the Duty Virologist and are available in the patient’s records.

Static information/disclaimer

​False negative results may occur for a variety of reasons including: inappropriate timing of sample collection, inappropriate sample type, inappropriate sample storage and presence of virus below the detectable limit of the assay. New and emerging variants may also occur which may not be detected by specific assays. Towards the limit of detection of an assay sampling variation will result in lower reproducibility. Haemolysed or lipaemic samples can also cause interference with assay results.

General additional information

​Please contact virologyadvice@nhslothian.scot.nhs.uk for all non-urgent clinical enquiries.

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Volume - Child 1

​1-2mls

Bocavirus PCR

Transport arrangements
Inter-site van shuttle service, GP van service, External hospital van service, Couriers, Hospital porter collection (refer to collection times posted in wards / departments), Hospital Pneumatic Tube System (PTS)
Sample storage arrangements

​Specimen transport arrangements must be in accordance with current postal and transport regulations. Samples should be transported to the laboratory without delay. If processing is delayed, refrigeration at 2-8 oC is preferable to storage at room temperature for all samples, with the exception of EDTA blood samples. EDTA blood samples must be stored at room temperature (19-23 oC). Patient samples can be transported at ambient temperature.

Special instructions for collection

​Clinical samples must be collected into leak-proof containers and placed into a sealed bag with absorbent material. Patient samples must be individually packaged and not mixed with other patient samples. Any appropriate hazard labelling should be clearly visible on the sample bag / sample.

How to request

Use appropriate TRAK or ICE barcode labels which include Patient Identifier Number (CHI), Forename, Surname, Date of Birth, Gender and Location of patient (hospital and ward or primary care centre). Use Virology Request Form only if TRAK or ICE ordering system is unavailable.

Availability

Weekdays 08.30 - 17.00 Weekends 9.00 - 16.00

Anticipated turnaround

​2 days

What happens if the result is positive or abnormal

​Positive results are notified to the Duty Virologist and are available in the patient’s records.

Static information/disclaimer

False negative results may occur for a variety of reasons including: inappropriate timing of sample collection, inappropriate sample type, inappropriate sample storage and presence of virus below the detectable limit of the assay. New and emerging variants may also occur which may not be detected by specific assays. Towards the limit of detection of an assay sampling variation will result in lower reproducibility. Haemolysed or lipaemic samples can also cause interference with assay results.

General additional information

Please contact virologyadvice@nhslothian.scot.nhs.uk for all non-urgent clinical enquiries.

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Volume - Child 1

​Throat swab

Preferred sample.

Volume - Child 2
​​Bronchoalveolar lavage taken into a 20ml Sterile Universal Conainer
Volume - Child 3
​Nasopharyngeal Secretions taken into Conical Centrifuge Tube

BRAF mutation analysis

Transport arrangements

​Referral specimens should be sent directly to Molecular Pathology at the above address (see transport recommendations). For patients with pathology specimens held within NHS Lothian there is no need to arrange transport of specimens.

How to request
Testing for NHS Lothian patients can be requested by email to molecular.pathoogy@nhslothian.scot.nhs.uk. Referral requests must be accompanied by a completed request form.
 
Please also refer to our detailed requesting instructions.
Availability

​​​Monday - Friday. 09:00 – 17:00

Anticipated turnaround

​​​An integrated Molecular Pathology report should be available within 10 working days. See results.

Static information/disclaimer

Analysis by NGS and Pyrosequencing are all accredited to ISO 15189.

Please note, alternative methodologies may be used. Full details will be included in all reports.

General additional information

​​BRAF codon 600 mutations are present in 37 to 50% of melanomas. BRAF inhibitors (e.g. vemurafenib, dabrafenib) and/or MEK inhibitors have been approved for patients with metastatic melanomas harbouring BRAF codon 600 mutations.

There are two methods available for the detection of mutations in codon 600 of the BRAF oncogene: Next generation sequencing (NGS) and  PCR followed by pyrosequencing. The pyrosequencing assay can detect any somatic mutations in codons 600 and 601 of the BRAF oncogene. The NGS panel assesses a larger region of the BRAF gene, for the full regions covered by the NGS panel, click here

Melanin is a known inhibitor of PCR reactions which may lead to a higher than expected test failure rate in melanoma specimens (see factors known to affect Molecular Pathology testing).

BRAF mutation analysis is also used in colorectal cancer specimens as a prognostic indicator and to differentiate sporadic mismatch repair defects from inherited forms in screening for Lynch Syndrome, as well as in the diagnosis of thyroid cancer for cases with indeterminate cytology results.

For clinical advice on appropriate investigations, please contact our Molecular Pathology team.

Mismatch repair testing

Transport arrangements

Referral specimens should be sent directly to Molecular Pathology at the above address (see transport recommendations). For patients with pathology specimens held within NHS Lothian there is no need to arrange transport of specimens.

How to request

Mismatch repair testing can be requested individually or will be performed reflexively for colorectal cancer patients as indicated below.

Testing for NHS Lothian patients can be requested by email molecular.pathology@nhslothian.scot.nhs.uk. Referral requests must be accompanied by a completed request form.

 

Please also refer to our detailed requesting instructions.

 

Availability

​​Monday - Friday. 09:00 – 17:00

Anticipated turnaround

​​An integrated Molecular Pathology report should be available within 42 days (Lynch syndrome investigations), or 14 days for histological diagnosis or treatment stratification. See results.

Static information/disclaimer

Mismatch repair immunohistochemistry is accredited to ISO 15189.  Microsatellite instability analysis and MLH1 promoter methylation are currently undergoing accreditation to ISO 15189:2012

Please note: alternative methodologies may be used. Full details will be included in all reports.

General additional information

A defective DNA mismatch repair pathway is one mechanism of carcinogenesis in colorectal cancer. Such defects may be sporadic or inherited.  One well characterised inherited condition, known as Lynch Syndrome, results in predisposition to the development of colorectal and other cancers at a comparatively young age. Patients with Lynch Syndrome have a 40-80% chance of developing colorectal cancer, in most cases before the age of 50 and affected women have a 40-60% risk of developing endometrial cancers and 10-12% risk of developing ovarian cancer.

Although the risk of developing cancer in Lynch Syndrome is high, knowing the risks and getting appropriate treatment can save lives. Mismatch repair analysis can also inform treatment options and, in the case of tumours showing medullary morphology, be a useful adjunct to the histopathological diagnosis.

Analysis for a mismatch repair pathway defect is performed in all newly diagnosed colorectal cancer (CRC) patients in Scotland.  Additionally, analysis of mismatch repair pathway defects may be performed on endometrial or ovarian cancers.  Where a patient presents to clinical genetics and Lynch Syndrome is suspected, assessment for mismatch repair defects may be performed on other cancer types.   The test used is dependent on the neoplastic content of the specimen; i.e. a sample with <20% tumour cells is assessed using immunohistochemistry (IHC) for four mismatch repair proteins (MLH1, PMS2, MHS2, MSH6).  Samples with >20% neoplastic cell content will be assessed for microsatellite instability (MSI).  MMR IHC will also be carried out to confirm equivocal MSI results as well as to determine which MMR proteins are affected.  Both MMR IHC and MSI will be carried out on patient samples referred from Clinical Genetics where there is a strong clinical suspicion of Lynch Syndrome.

Patients whose cancers are found to have a defect within MSH2 & MSH6, PMS2 or MSH6 should be referred to clinical genetics for further assessment.  CRC specimens that have a loss of MLH1 expression are further assessed for the presence of a BRAF V600E mutation.  Coexistence of loss of MLH1 protein expression and the presence of a BRAF V600E mutation in CRC is indicative of a sporadic tumour, rather than one associated with Lynch syndrome, and thus these patients are not routinely referred to clinical genetics.

Where loss of MLH1 protein expression is identified (and no BRAF V600E mutation within CRC cases), assessment of the methylation status of the MLH1 promoter region is performed using a methylation specific ligation-dependent probe amplification (MS-MLPA) assay.  Methylation of the promoter region of MLH1 is indicative of a sporadic tumour while a lack of methylation is interpreted as being suspicious of Lynch Syndrome.  Therefore, if methylation is detected within the MLH1 promoter region, referral to clinical genetics is not advised.  Where no methylation of the MLH1 promoter region is identified but loss of MLH1 protein expression exists, the patient should referred to clinical genetics for further investigation.

In recent years rare cases of constitutional MLH1 hypermethylation together with a somatic mutation in the functional allele have been reported in Lynch Syndrome.  In situations where MLH1 methylation is detected in somatic tissue, MLH1 promoter methylation analysis is performed on “normal” (non tumour) DNA from the patient (when available) to determine whether the methylation is constitutional in nature.

For clinical advice on appropriate investigations, please contact our Molecular Pathology team.

 

KIT and PDGFRA mutation analysis

Transport arrangements

​Referral specimens should be sent directly to Molecular Pathology at the above address (see transport recommendations). For patients with pathology specimens held within NHS Lothian there is no need to arrange transport of specimens.

How to request
Testing for NHS Lothian patients can be requested by email to molecular.pathology@nhslothian.scot.nhs.uk. Referral requests must be accompanied by a completed request form.
 
 
 
Please also refer to our detailed requesting instructions.
Availability

​​Monday - Friday. 09:00 – 17:00

Anticipated turnaround

​​An integrated Molecular Pathology report should be available within 10 working days. See results.

Static information/disclaimer

Analysis by Sanger sequencing is accredited to ISO 15189.

The NGS test is accredited to ISO 15189.

Please note: alternative methodologies may be used. Full details will be included in all reports.

General additional information

​In gastrointestinal stromal tumours (GIST), the identification of KIT (exons 9, 11, 13 and 17) and PDGFRA (exons 12, 14, 18) mutations can aid histopathological diagnosis. In addition, KIT and PDGFRA mutations can help predict response to therapies including imatinib and sunitinib. KIT and PDGFRA mutation analysis is carried out by NGS or by Sanger sequencing.

A proportion of melanomas, most commonly acral and mucosal melanomas, also exhibit mutations in exons 9, 11, 13 and 17 of the KIT gene.

For clinical advice on appropriate investigations, please contact our Molecular Pathology team.

NRAS mutation analysis

Transport arrangements

​Referral specimens should be sent directly to Molecular Pathology at the above address (see transport recommendations). For patients with pathology specimens held within NHS Lothian there is no need to arrange transport of specimens.

How to request

NRAS mutation analysis can be requested individually or as part of the colorectal cancer panel.

Testing for NHS Lothian patients can be requested by email to molecular.pathology@nhslothian.scot.nhs.uk. Referral requests must be accompanied by a completed request form.

 

Please also refer to our detailed requesting instructions.
Availability

​​Monday - Friday. 09:00 – 17:00

Anticipated turnaround

​​An integrated Molecular Pathology report should be available within 10 working days. See results.

Static information/disclaimer

This pyrosequencing assay is accredited to ISO 15189. The NGS test is also accredited to ISO 15189:2012

Please note: alternative methodologies may be used. Full details will be included in all reports.

General additional information

NRAS is member of the RAS family of small GTPases and is related to KRAS. Like KRAS, the NRAS gene can be mutated in a number of different cancer types. NRAS mutation analysis is carried out using NGS or pyrosequencing to detect mutations in exons 2 or 3 (codons 12, 13, 59 and 61) of the NRAS oncogene, which account for the majority of clinically relevant ‘hot-spot’ mutations in colorectal cancer and some melanomas.

For clinical advice on appropriate investigations, please contact our Molecular Pathology team.

MGMT promoter methylation analysis

Transport arrangements

​Referral specimens should be sent directly to Molecular Pathology at the above address (see transport recommendations). For patients with pathology specimens held within NHS Lothian there is no need to arrange transport of specimens.

How to request

Testing for NHS Lothian patients can be requested by email to molecular.pathology@nhslothian.scot.nhs.uk. Referral requests must be accompanied by a completed request form.

 

Please also refer to our detailed requesting instructions.
Availability

​​Monday - Friday. 09:00 – 17:00

Anticipated turnaround

​​An integrated Molecular Pathology report should be available within 7 days. See results.

Static information/disclaimer

This test is accredited to ISO 15189.

Please note: alternative methodologies may be used. Full details will be included in all reports.

General additional information

​O6-Methylguanine-DNA-methyltranferase (MGMT) is a DNA repair enzyme which is thought to repair DNA damage caused by alkylating chemotherapeutic agents such as temozolomide. Methylation of the MGMT gene promoter decreases its expression and has been found to correlate with longer survival of patients with high grade gliomas treated with temozolomide. MGMT promoter methylation is therefore measured in high grade gliomas to help predict a patient’s response to therapy.

MGMT promoter methylation analysis is carried out by PCR and pyrosequencing following bisulphite conversion of unmethylated DNA. The reported result is an estimate derived from the mean percentage of methylation at CpG sites 76 to 79.

For clinical advice on appropriate investigations, please contact our Molecular Pathology team.

KRAS mutation analysis

Transport arrangements

Referral specimens should be sent directly to Molecular Pathology at the above address (see transport recommendations). For patients with pathology specimens held within NHS Lothian there is no need to arrange transport of specimens.

How to request

KRAS mutation analysis can be requested individually or as part of either the lung cancer panel or the colorectal cancer panel.

Testing for NHS Lothian patients can be requested by email to molecular.pathology@nhslothian.scot.nhs.uk. Referral requests must be accompanied by a completed request form.

 
Please also refer to our detailed requesting instructions.
Availability

​​Monday - Friday. 09:00 – 17:00

Anticipated turnaround

​​An integrated Molecular Pathology report should be available within 10 working days. See results.

Static information/disclaimer

The pyrosequencing test is accredited to ISO 15189.  The NGS test is also accredited to ISO 15189:2012

Please note: alternative methodologies may be used. Full details will be included in all reports.

General additional information

​The KRAS protein is a small GTPase involved in regulation of cellular proliferation, survival and differentiation. It frequently occurs as a mutated activated form in a number of different cancer types. KRAS mutation analysis is carried out as part of the colorectal cancer and lung cancer testing panels.

KRAS mutation analysis is carried out using PCR followed by pyrosequencing or NGS to detect mutations in exons 2, 3 or 4 (codons 12, 13, 61, 117 and 146) of the KRAS oncogene, which account for the majority of clinically relevant ‘hot-spot’ mutations. In colorectal cancer KRAS mutation analysis is usually carried out in a panel with NRAS mutation analysis.

In lung cancer, codons 12, 13 and 61 account for the majority of clinically relevant KRAS mutations and are most commonly associated with adenocarcinomas from patients with a smoking history (approximately 40% incidence).

For clinical advice on appropriate investigations, please contact our Molecular Pathology team.

HER2 gene amplification

Transport arrangements

Referral specimens should be sent directly to Molecular Pathology at the above address (see transport recommendations). For patients with pathology specimens held within NHS Lothian there is no need to arrange transport of specimens.

How to request
Testing for NHS Lothian patients can be requested by email to molecular.pathology@nhslothian.scot.nhs.uk. Referral requests must be accompanied by a completed request form.
 
 
Please also refer to our detailed requesting instructions.
Availability

​​Monday - Friday. 09:00 – 17:00

Anticipated turnaround

​​An integrated Molecular Pathology report should be available within 10 working days. See results.

Static information/disclaimer

This test is accredited to ISO 15189.

Please note: alternative methodologies may be used. Full details will be included in all reports.

General additional information

​Trastuzumab, in combination with cisplatin and capecitabine or 5-fluorouracil, is recommended as an option for the treatment of people with human epidermal growth factor receptor 2 (HER2) amplified metastatic adenocarcinoma of the stomach or gastro-oesophageal junction, who have not received prior treatment for their metastatic disease, and who have tumours expressing high levels of HER2 protein or with amplification of the HER2 gene.

HER2 expression is assessed by immunohistochemistry (IHC) using the Leica Oracle HER2 IHC system. Tumours exhibiting equivocal HER2 expression proceed to FISH analysis using a Vysis PathVysion HER2 DNA probe (Abbott Molecular) to identify HER2 gene amplification.

HER2 status is also used within Pathology to assess eligibility for trastuzumab therapy in breast cancer patients.

For clinical advice on appropriate investigations, please contact our Molecular Pathology team.

EGFR mutation analysis (FFPE)

Transport arrangements

Referral specimens should be sent directly to Molecular Pathology at the above address (see transport recommendations). For patients with pathology specimens held within NHS Lothian there is no need to arrange transport of specimens.

How to request

​​EGFR mutation analysis can be requested individually or as part of the lung cancer panel. EGFR mutation analysis may, in some circumstances, also be performed on cell-free tumour DNA (cfDNA) isolated from blood.

Testing for NHS Lothian patients can be requested by email to molecular.pathology@nhslothian.scot.nhs.uk. Referral requests must be accompanied by a completed request form.
 
 
Please also refer to our detailed requesting instructions.
Availability

​​Monday - Friday. 09:00 – 17:00

Anticipated turnaround

​​An integrated Molecular Pathology report should be available within 10 working days. See results.

Static information/disclaimer

NGS and analysis by COBAS EGFR test are both accredited to ISO 15189.  

Please note, alternative methodologies may be used. Full details will be included in all reports.

General additional information

​Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are currently used as first line treatment for patients with advanced metastatic non-small cell lung cancer (NSCLC). Somatic mutations in exons 18 to 21 of the EGFR gene are used to predict response to EGFR TKIs.

Molecular Pathology use an NGS panel or the COBAS® EGFR mutation kit (Roche Diagnostics) for the detection of EGFR variants.  Further details of the NGS panel and regions analysed can be found here.  The COBAS EGFR mutation kit  can detect 41 mutations in exons 18-21 of the EGFR gene: 30 deletions and complex mutations in exon 19; c.2369C>T p.(Thr790Met); c.2303G>T p.(Ser768Ile); c.2573T>G or c.2573_2574delTGinsGT p.(Leu858Arg); c.2155G>A p.(Gly719Ser); c.2156G>C p.(Gly719Ala); c.2155G>T p.(Gly719Cys); and 4 insertions in exon 20. The assay detects 86.7% of known mutations in exons 18 to 21 as listed in the Catalogue of Somatic Mutations in Cancer.

EGFR mutation analysis is carried out as part of the lung cancer testing panel, which also includes KRAS mutation analysis, PD-L1 expression and detection of ALK and ROS1 gene rearrangements.

For clinical advice on appropriate investigations, please contact our Molecular Pathology team.

ALK gene rearrangement

Transport arrangements
Referral specimens should be sent directly to Molecular Pathology at the above address (see transport recommendations). For patients with pathology specimens held within NHS Lothian there is no need to arrange transport of specimens.
How to request

​ALK gene rearrangement analysis can be requested individually or as part of the lung cancer panel.

Testing for NHS Lothian patients can be requested by email to molecular.pathology@nhslothian.scot.nhs.uk.
 
Referral requests must be accompanied by a completed
 
Please also refer to our detailed requesting instructions.
Availability

​Monday - Friday. 09:00 – 17:00

Anticipated turnaround

​An integrated Molecular Pathology report should be available within 10 working days. See results.

Static information/disclaimer

ALK FISH is accredited to ISO15189.

ALK Immunohistochemistry is not currently accredited to ISO15189.

Please note, alternative methodologies may be used. Full details will be included in all reports.

General additional information

​The anaplastic lymphoma kinase (ALK) gene encodes a tyrosine kinase normally expressed in neuronal cells. The ALK gene can, by deletion or translocation, form a fusion protein, which is abnormally expressed in approximately 2 to 5% of patients with non-small cell lung cancer. The presence of ALK gene rearrangement predicts response to ALK inhibitor therapy.

Immunohistochemistry is carried out to detect the ALK fusion protein using the D5F3 clone (Cell Signaling). ALK gene rearrangement analysis is carried out by fluorescence in-situ hybridization (FISH).

Analysis of the ALK gene is carried out as part of the lung cancer testing panel, which also includes EGFR and KRAS mutation analysis, PD-L1 expression and detection of ROS1 gene rearrangments.

​For clinical advice on appropriate investigations, please contact our Molecular Pathology team.

Sweat Test

Special instructions for collection

Sweat collection
Arrange sweat tests with the Department of Respiratory Medicine. Sweat is collected from a small carefully cleaned area of skin stimulated by pilocarpine, and chloride concentration is measured. Properly performed, this test is valuable in the diagnosis of cystic fibrosis, but reliable results can only be obtained with care, experience and attention to detail. If insufficient sweat is collected, or if abnormal or intermediate results are obtained, a repeat sweat collection may be required.
General additional information

Interpretation

 
All Scottish newborns are screened for cystic fibrosis by immunoreactive trypsin, and a panel of common Scottish cystic fibrosis mutations. Positive results are confirmed by sweat testing. Patients of all ages with symptoms or signs suggestive of cystic fibrosis are also sweat tested, whether or not they have been screened as neonates.
 
Sweat chloride (mmol/L)
0-6months old: <30mmol/L
>6months old: < 40 mmol/L.
 
Children with cystic fibrosis have sweat chloride greater than 60 mmol/L. Normal or intermediate sweat chloride (30/40 – 60mmol/L) may be associated with some mild CFTR mutations. Abnormal results (chloride greater than 60 mmol/L), and intermediate results in the 30/40 - 60 mmol/L range, should always be followed up, by CF mutation analysis and or/ a repeat sweat test.
 
Sweat conductivity is analysed in addition to chloride, however chloride remains the diagnostic parameter. The minimum sweat volume required for reliable interpretation is 1g/m2/min. All collections over 10uL are analysed [Guidelines for the Performance of the Sweat Test for the Investigation of Cystic Fibrosis in the UK. 2nd edn 2014]

MPL exon 10

Transport arrangements

Specimens should be kept at room temperature and sent directly to the laboratory as soon as possible by first class post.

Sample storage arrangements

Specimens must NOT be frozen. If a delay in sending a specimen is unavoidable it must be refrigerated overnight.

How to request

Request form, or can be added onto a previous JAK2 V617F sample via the MPN Mailbox: Molecular.MPN@nhslothian.scot.nhs.uk

Availability

Test not available during restricted service

Anticipated turnaround

28 days

What happens if the result is positive or abnormal

Genetic results will not be telephoned. They can be emailed if secure addresses are verified.

Static information/disclaimer

​This test is accredited to ISO 15189:2022​​​

General additional information

Variants in MPL exon 10 are tested for in patients with clinical details of “Essential Thrombocythaemia' or 'Myelofribrosis” and have previously tested 'Not Detected' for both JAK2 V617F and Calreticulin indel Mutations. The MPL exon 10 is screened using an HRM method, followed by direct sequencing for the confirmation and classification of any potential mutations detected. This HRM method is sensitive to approximately 5-10%.

See the relevant BCSH guidelines for further information:

https://b-s-h.org.uk/guidelines/guidelines/gpp-use-of-genetic-tests-to-diagnose-and-manage-patients-with-myeloproliferative-and-myeloproliferativemyelodysplastic-neoplasms-and-related-disorders/

Citrated anticoagulated venous blood or 150µl DNA may be sent instead of an EDTA specimen

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Calreticulin (CALR exon 9)

Transport arrangements

Specimens should be kept at room temperature and sent directly to the laboratory as soon as possible by first class post.

Sample storage arrangements

Specimens must NOT be frozen. If a delay in sending a specimen is unavoidable it must be refrigerated overnight.

How to request

Request form, or can be added onto a previous JAK2 V617F sample via the MPN Mailbox: Molecular.MPN@nhslothian.scot.nhs.uk

Availability

Test not available during restricted service.

Anticipated turnaround

28 days

What happens if the result is positive or abnormal

Genetic results will not be telephoned. They can be emailed if secure addresses are verified.

Static information/disclaimer

​This test is accredited to ISO 15189:2022

General additional information

Mutations in Calreticulin Exon 9 are tested for in patients with Essential Thrombocythaemia or Myelofibrosis and have previously tested 'Not Detected' for JAK2 V617F. ​

Frameshift indels within exon 9 of CALR are detected by fragment analysis, supported with direct sequencing for any mutations detected. Fragment analysis has an estimated sensitivity of approximately 3%. Any samples which have no variants detected in CALR exon 9 proceed to testing for MPL exon 10 mutations by HRM and direct sequencing.

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JAK2 Exon12

Transport arrangements

Specimens should be kept at room temperature and sent directly to the laboratory as soon as possible by first class post.​

Sample storage arrangements

Specimens must NOT be frozen. If a delay in sending a specimen is unavoidable it must be refrigerated overnight. ​

How to request

Request form, or can be added onto a previous JAK2 V617F sample via the MPN Mailbox: Molecular.MPN@nhslothian.scot.nhs.uk

Availability

Test not available during restricted service.​

Anticipated turnaround

28 days

What happens if the result is positive or abnormal

Genetic results will not be telephoned. They can be emailed if secure adresses are verified. ​

Static information/disclaimer

​This test is accredited to ISO 15189:2022​​​

General additional information

Variants in JAK2 Exon12 are tested for in patients with suspected “Polycythaemia vera?” and have previously tested 'Not Detected' for JAK2 V617F. The JAk2 Exon12 is screened using an HRM method, followed by direct sequencing for the confirmation and classification of any potential mutations detected. This HRM method is sensitive to approximately 5-10%.

 

See the relevant BCSH guidelines for further information:

https://b-s-h.org.uk/guidelines/guidelines/diagnosis-and-management-of-polycythaemia-vera/

Citrated anticoagulated venous blood or 150µl DNA may be sent instead of an EDTA specimen

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Vitamin K

Special instructions for collection

Fasting sample or 8 hours after supplementation is recommended.

How to request

Only available for cystic fibrosis patients or those on home parenteral nutrition. Please ensure this is written on form. Recommend a prothrombin time is performed in all adults for ?vitamin K deficiency.

Anticipated turnaround

28 days

General additional information

Vitamin K is light sensitive, please protect specimen from light.

Samples sent to Scottish Trace Element and Micronutrient Reference Laboratory.

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Volume - Child 1

1 mL

Additive - Child 1

Lithium heparin

Volume - Adult 1

1 mL

Volume - Adult 2

1 mL

Additive - Adult 1

Lithium heparin (non gel)

Additive - Adult 2

Potassium EDTA

Oral Fluid Drugs of Abuse screen

Sample storage arrangements

​Refrigerate until transported to laboratory

Special instructions for collection

​How to collect saliva using the Sarstedt Salivette device:

1) Remove the top cap of the tube to expose the round sponge. Do not remove the holder that the sponge sits in.

2) Place the sponge in your mouth by tipping the tube so the sponge falls into your mouth. Do not touch the sponge with your fingers.

3) Keep the sponge in your mouth. Very gently chew and roll the sponge around your mouth for 1-2 minutes. Spit the sponge back into the inner sleeve of the tube. Do not touch the sponge with your fingers.

4) Replace the cap. Make sure cap is on tightly.

5) Label the Salivette tube with the patient's full name, date of birth and date/time of collection. Complete all details on the request form, including full name, date of birth, CHI or registration number, requesting location and clinician, time/date of collection and specimen type, requesting a drug screen.

How to request

​Oral fluid drugs of abuse can be requested on TRAK, GP ICE or using a standard blood science request form. Indicate the sample type as oral fluid.

Anticipated turnaround

7 days

What happens if the result is positive or abnormal

​Drugs are analysed by a specific tandem mass spectrometry method. Drugs are validated by the presence of quantifying ions and qualifying ions. Both of these must have a retention time that matches each other and the corresponding deuterated internal standard. Drugs at a level above its threshold level are reported as positive.

General additional information

The report will contain 8 core drugs:

- Opiate group (morphine, codeine, 6-mono-acetyl morphine (heroin metabolite), dihydrocodeine, oxycodone - individual drugs reported only when the group is positive)

- Amphetamine

- Cocaine (benzoylecgonine is also measure but not reported - it's presence confirms that cocaine has been metabolised by the liver)

- Methadone

- Benzodiazepine group (diazepam, temazepam, oxazepam, nitrazepam, nordiazepam (metabolite of diazepam and chlordiazepoxide - individual drugs are not reported)

- Gabapentin

- Pregabalin

- Buprenorphine

 

The following drugs are only reported when positive (ie. if not listed, negative status can be assumed):

MDMA (ecstasy), Methamphetamine, Tramadol.

'Street' benzodiazepines including: Alprazolam (Xanax), Etizolam, Bromazolam

 

Drug threshold levels:

Morphine: 20µg/L when the only drug present, 10µg/L when 6MAM is positive. Morphine is a metabolite of both codeine and 6MAM and it's presence with these supports the consumption of codeine or heroin. Morphine only is also compatible with MST and other morphine preparations.

6MAM (heroin metabolite): 13µg/L

Codeine: 20µg/L (compatible with codeine but also acetyl codeine found in heroin)

Dihydrocodeine: 20µg/L

Oxycodone: 20µg/L (compatible with oxycodone, oxynorm, oxycontin)

Amphetamine, methamphetamine, MDMA: 30µg/L

Cocaine: 13µg/L The presence of cocaine metabolite (benzoylecgonine) indicates that cocaine has been consumed.

Methadone: 20µg/L

Gabapentin, Pregabalin, Tramadol: 40µg/L

Buprenorphine: 1µg/L. Note very high levels are seen if the sample is collected within a short time after sublingual administration of buprenorphine. Half life of buprenorphine varies widely from 2-24 hrs. Negative results can be seen in some patients on low dose (8mg/day) if the sample is collected more than 10 hours after a dose.

Prescription Benzodiazepines: Diazepam, Nordiazepam (chlordiazepoxide metabolite), 1µg/L

                                                 Temazepam, Nitrazepam, 10µg/L

'Street' benzodiazepines: Alprazolam (Xanax), Etizolam, Bromazolam: 1µg/L

 

Please contact Toxicology Clinical Lead (0131 242 6851) for further information and advice.

Volume - Child 1

​50µL

Volume - Adult 1

50µL

Midazolam

How to request

​Contact Duty Biochemist to discuss.

Anticipated turnaround

​Dependent on method of transport of sample. 48 hours from receipt in Cardiff.

General additional information

​Please note: this assay is not sensitive enough for use in brain stem death testing. It is possible for other medications to interfere with analysis. Please provide list of current medications with requests.

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Volume - Adult 1

​5.0 mL

Additive - Adult 1

​Potassium EDTA

Creatinine Clearance

Special instructions for collection

At start of the collection period the patient empties bladder and discards the sample. All urine must be collectedfor 24 hours. The patient must empty bladder at the end of the collection period and add this to the urine collection. A serum / plasma sample should be collected during the 24 hour period that the urine is collected.​

Availability

​Monday-Friday 9.00-17.00, Saturday 9.00-13.00

Anticipated turnaround

​2 days

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Tryptase

Special instructions for collection
Investigation of anaphylactic reactions would be better conducted with serial samples (minimum of three):
 
Sample 1 (to detect early peak levels with severe reactions) - as soon as possible, but do not delay management.
 
Sample 2 (detects peak level with typical reactions) - 1-2 hours after reaction.
 
Sample 3 (to measure baseline level) - 24 hours after reaction.
 
Note that it is essential that all samples and accompanying request forms state the time of the adverse reaction and also have the precise time and date of the sample so that the results can be interpreted in relation to the event.

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

Normal working hours 9am-5pm Mon to Fri

Anticipated turnaround
21 Days
 
 
What happens if the result is positive or abnormal

General additional information
Tryptase levels are used as an aid in the clinical diagnosis of systemic mastocytosis and mast cell activation events such as anaphylaxis.
Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Specific IgG Antibody against Fungal and Avian Precipitins

How to request

​Trak, ICE, Clinical Immunology request form

Availability

Normal working hours 9am-5pm Mon to Fri.

Anticipated turnaround
14 Days
 
 

What happens if the result is positive or abnormal

Reviewed and authorised by Consultant Immunologist.

General additional information
a. Aspergillus Fumigatus
b. Budgerigar
c. Pigeon
e. Parrot - This test is no longer available

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Specific IgE

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround

21 Days

What happens if the result is positive or abnormal

Reviewed and authorised by Consultant Immunologist.

General additional information
The following allergens can be tested for:
 
House dust mite
Egg white
Pork - Not available at the moment
Cow’s milk
Wheat
Cod
Coconut
Sesame 
Tuna
Peanut 
Soya
Salmon
Hazelnut
Brazil nut
Almond 
Crab
Shrimp
Gluten
Kiwi
Melon 
Banana
Pecan
Cashew
Pistachio
Lentil - Not accredited
Walnut
Pine nut
Honeybee venom
Common Wasp Venom 
Horse dander
Dog dander
Cat dander
Rape seed pollen
Penicilloyl G
Penicilloyl V
Ampicilloyl
Amoxicilloyl
Suxamethonium 
Latex
Mouse epithelium
 
Mouse Urine 
Rat epithelium
Rat urine
Aspergillus
Blue mussel
Omega-5-gliadin
 
 
 
 
Mixed Animal (cat, dog, horse & cow dander)
Mixed Grass Pollen (sweet vernal, rye, timothy, cultivated rye & velvet grass)
Mixed Nuts (peacan, cashew, pistachio & walnut)
Mixed Nuts (peanut, hazelnut, brazil nut, almond & coconut)
Mixed Fish (cod, shrimp, bluemussel, tuna & salmon)
Mixed Rodent (guinea pig, rabbit, hamster, rat & mouse)
Mixed Feathers (goose, chicken, duck & turkey)
Mixed Feather (budgerigar, canary, parakeet, parrot & finch)
Mixed Tree Pollen (Box-elder, silver birch, oak, elm & walnut)
Mixed Moulds (Penicillium notatum, Cladosporium herbarum, Aspergillus fumigatus & Alternaria alterata)
 

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Total IgE

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

​Normal working hours 9am-5pm Mon to Fri.

Anticipated turnaround
14 Days
 
 

What happens if the result is positive or abnormal

General additional information

​The measurement of total IgE levels has become well established in the investigation of allergic patients. Although IgE has the lowest concentration of all the Immunoglobulins, it has an extremely important role from a clinical standpoint because of its central involvement in allergic disorders. IgE is a monomer, with a molecular weight of 190,000 kDa and a serum concentration of 0.05 mg/dl. The serum concentration of IgE is significantly elevated in patients suffering from extrinsic asthma, hayfever and atopic eczema. IgE levels can also be raised in certain parasitic infections, some forms of immunodeficiency and bronchopulmonary aspergillosis.

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Immunoglobulin G and Subclasses

Special instructions for collection

Serum samples only please.

How to request

All requests for this test must be made through Clinical Immunology on a Clinical Immunology request form.

Availability

Normal working hours Mon-Fri 9am to 5pm.

Anticipated turnaround
21 Days

What happens if the result is positive or abnormal

General additional information

Please refer to Sheffield Department of immunology for current accreditation information and reference ranges.

 

 

Volume - Child 1

4.9ml

Additive - Child 1

Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

Clotting activator/gel

Anti-Liver/Kidney Microsomal Antibody

Special instructions for collection

Serum samples only please.

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

​Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround
14 Days

What happens if the result is positive or abnormal

​Reviewed and authorised by Consultant Immunologist.

General additional information
Tested along with GPC, AMA and SMA
 
Diagnosis of Type 2 autoimmune hepatitis in the young.
 
IIF using sections of rat kidney, liver and stomach.
LKM antibodies are strongly associated with Type 2 autoimmune hepatitis but are also found in a subset of patients with chronic hepatitis C infection.

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting/activator gel

Anti-Smooth Muscle Antibody

Special instructions for collection

Serum samples only please.

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

​Normal working hours 9am-5pm Mon to Fri.

Anticipated turnaround
14 Days

What happens if the result is positive or abnormal

Reviewed and authorised by Consultant Immunologist.

General additional information
Tested alongside GPC, AMA and LKM.
 
Anti-Smooth Muscle antibodies are associated with Type 1 autoimmune hepatitis and can also be seen in viral hepatitis, infectious mononucleosis, asthma, yellow fever and malignant tumours (carcinomas of the ovary, malignant melanoma) and they have been found in less than 2% of the normal population.
 
Indirect immunofluorescence (IIF) using rat liver, kidney and stomach tissue block. This antibody is measured on a combined liver, kidney and stomach section and so the results for Anti-Mitochondrial antibodies, Gastric parietal cell antibodies and Liver kidney Microsomal antibodies will also be reported.
 
 

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Anti-Mitochondrial Antibody

Special instructions for collection

Serum samples only please.

How to request

​Trak, ICE, Clinical Immunology request form.

Please note there is a change in reference range for this assay.  This assay is not accredited to ISO 15189.

Availability

Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround

14 Days for IIF (Anti-Mitochondrial antibody)

21 Days for Fluoroenzymeimmunoassay (M2)

What happens if the result is positive or abnormal

Reviewed and authorised by Consultant Immunologist.

General additional information
Tested alongside GPC, SMA and LKM
 
These antibodies are associated with primary biliary cirrhosis/ autoimmune liver disease.
 
Tested by Indirect immunofluorescence (IIF) using sections of rat liver, kidney and stomach. This antibody is measured on a combined liver, kidney and stomach section and so the results for anti-gastric parietal cell antibodies and anti-smooth muscle antibodies will also be reported. If AMA are observed the sera are further tested using an M2-specific ELISA.
Anti-Mitochondrial antibodies of the M2 type are present in at least 90% of patients with PBC where they are considered diagnostic but can also be present in other autoimmune diseases such as Sjogrens syndrome, autoimmune thyroid disease, SLE or polymyositis. Can be associated with anti-smooth muscle antibodies in PBC/CAH overlap.
Non-M2 AMA antibodies can also be associated with PBC (M4, M8 & M9) but may also be indicative of syphilis, connective tissue diseases, cardiomyopathy and drug-induced hepatitis. Please note that the laboratory does not subtype non-M2 anti-mitochondrial antibodies.

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Gastric Parietal Cell Antibody

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround

14 Days

What happens if the result is positive or abnormal

Reviewed and authorised by Consultant Immunologist.

General additional information
Tested alongside AMA, SMA and LKM.
 
Diagnosis of pernicious anaemia.
 
Indirect immunofluorescence (IIF) on rat gastric mucosa. This antibody is measured on a combined liver, kidney and stomach section and so the results for anti-mitochondrial antibodies, anti-smooth muscle antibodies and anti-liver kidney microsomal antibodies will also be reported.
Anti-Gastric Parietal cell antibodies may be detected following infection, in some normal individuals, in some organ specific autoimmune conditions (e.g autoimmune thyroid disease) as well as in pernicious anaemia.
PCA have also been reported in H.pylori-induced gastritis. The presence of these antibodies can be masked by anti-mitochondrial antibodies and so are not reported if the latter are present.

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Anti-Nuclear Antibody

Special instructions for collection

Serum samples only please.

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround
 

​14 Days

What happens if the result is positive or abnormal

Reviewed and authorised by Consultant Immunologist.

General additional information
The major reason for ordering the ANA test is as an aid to the diagnosis of a range of connective tissue diseases (CTDS) including Systemic Lupus Erythematosus (SLE), Sjogren's syndrome and Systemic Sclerosis (SS). Anti-nuclear antibodies, particularly at low titres may also be seen following infection, with certain drug therapies and in a number of other autoimmune/inflammatory conditions, and are found frequently in the normal, especially elderly, population.
 
Indirect immunofluorescence (IIF) is performed on fixed HEp2 cells. the titre of antibody and the pattern of staining is reported. This cell line has large nuclei which allows better definition of the staining pattern and there are also significant numbers of dividing cells allowing detection of autoantibodies to cell cycle specific antigens such as centromere proteins.
Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Intrinsic Factor Antibody

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround
14 Days
 
What happens if the result is positive or abnormal

General additional information

​Diagnosis of pernicious anaemia (positive in ~70% of patients with pernicious anaemia).

Pernicious anaemia is a chronic disease at the end stage of type A (autoimmune) chronic atrophic gastritis. Type A is autoimmune in nature and associated with pernicious anaemia. Type B (non-autoimmune) is associated with H.pylori infection. During the progression of type A chronic atrophic gastritis, gastric parietal cells which produce intrinsic factor and HCl, and zymogenic cells which produce pepsinogen, are destroyed and production of Intrinsic Factor (IF) and HCl is eliminated. Intrinsic Factor is essential for the absorption of vitamin B12 from the intestine and its absence leads to vitamin B12 deficiency and megaloblastic anaemia. Diagnosis of pernicious anaemia is important for the treatment of the anaemia itself and prevention of irreversible neurological damage. Circulating antibodies to Intrinsic Factor are highly specific and can be detected in >50% of cases with pernicious anaemia. These antibodies are of 2 types: Type 1, blocking antibodies which prevent the binding of vitamin B12 to the IF molecule and Type 2 antibodies which may interfere with the binding of the IF-vitamin B12 complex to the ileal receptor.

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Rheumatoid Factor

How to request

​Trak, ICE, Clinical Immunology request form.

This test can only be requested by specified Rheumatology Consultants.

Please note there is a change in reference range for this assay.  This assay is not accredited to ISO 15189.

Availability

Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround

21 Days

What happens if the result is positive or abnormal

Reviewed and authorised by Consultant Immunologist

General additional information

​Diagnosis of seropositive rheumatoid arthritis, differential diagnosis of rheumatic disease.

High levels of RF may be seen in Rheumatoid Arthritis, Subacute Bacterial Endocarditis (SBE), Sjogrens syndrome, and other infections and autoimmune/inflammatory conditions. RF is of no use in monitoring disease activity in RA where C-Reactive protein levels should be used.

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Cyclic Citrullinated Peptide

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround
7 Days
 
 

What happens if the result is positive or abnormal

General additional information

​Diagnosis of seropositive rheumatoid arthritis, differential diagnosis of rheumatic disease.

Anti-CCP antibodies are more specific than Rheumatoid Factor for diagnosing Rheumatoid Arthritis (RA) and are present in approximately 70% of early stage RA patients. They are good predictors of radiographic joint disease and may be useful in discriminating between erosive osteoarthritis and RA. These antibodies may be present up to 10 years prior to diagnosis and so are highly predictive of the future development of RA in both healthy subjects and patients with undifferentiated arthritis.

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Extractable Nuclear Antigen

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

​Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround
21 Days
 
What happens if the result is positive or abnormal

Reviewed and authorised by Consultant Immunologist.

General additional information
Assays to determine ENA specificities in the evaluation of any patient suspected of having a systemic connective tissue disease.
 
Samples for Anti-ENA are initially screened using a Fluorescence Enzyme Immunoassay (FEIA) containing all seven antigens. Positive samples are further investigated to identify the individual specificities. the clinical interpretation depends on the ENA specificities that are detected.
 
Antibodies to Sm and RNP Antigens
 
Antibody to Sm antigen is found in a minority of patients with SLE for which it is a very specific marker. the presence of antibody to RNP is found in patients with a variety of systemic connective tissue diseases, including SLE, discoid LE, RA and SS and mixed connective tissue disease.
 
Antibodies to Ro (SS-A) and La (SS-B) Antigens
 
Anti-Ro antibody is associated with Primary Sjogrens syndrome and less commonly with SLE. There seems to be close association between the presence of this antibody system and photosensitivity. Two forms of Ro are found, known as Ro60 and Ro52 and antibodies to both may be clinically significant. Both specificities are detected in the assay used. In women of child bearing age Ro antibody is associated with risk of congenital heart block and neonatal lupus.
 
Antibodies to Scl-70 Antigens
 
Anti-Scl-70 identifies DNA Topoisomerase-1 and is one of several antibodies which give rise to nucleolar staining. This antibody is associated with the more diffuse form of scleroderma/systemic sclerosis, and with impaired pulmonary diffusion.
 
Antibodies to Jo-1 Antigens
 
Anti-Jo-1 is the most common of a group of myositis-specific antibodies (MSAs) which includes Anti-PL12, Anti-OJ, Anti-Mi-2 and Anti-SRP. These antibodies target aminoacyl-tRNA synthetases (histidyl-in the case of Jo-1). Jo-1 occurs rarely in polymyositis and dermatomyositis, and when present is associated with an increased risk of interstitial lung disease.
 
Antibodies to Centromere Antigens
 
Anti-centromere antibodies (ACAs; often styled solid, anticentromere) are autoantibodies specific to centromere and kinetochore function. They occur in some autoimmune diseases, frequently in limited systemic scleroderma (formerly called CREST syndrome), and occasionally in the diffuse form of scleroderma. They are rare in other rheumatic conditions and in healthy persons.
 
 
 
 
Volume - Child 1

4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Anti-Insulinoma Antigen-2 Antibody

Special instructions for collection

Serum samples only please.

How to request

​Trak, ICE, Clinical Immunology request form.

Diabetic tests can only be requested via Hospital referrals.

Availability

Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround
21 Days
 
 
General additional information

Islet antigen-2(IA-2),pre Islet antigen (IA-2), previously known also as ICA-512, is a major target of islet cell autoantibodies. Autoantibodies to IA-2 are present in up to 80% of children and adolescents at diagnosis of type 1 diabetes. Testing for IA-2A complements GAD measurement, since more than 90% of children have antibodies to at least one of these proteins at diabetes onset. IA-2 generally develops later in the process leading to type 1 diabetes and is therefore associated with more rapid progression. These antibodies do not persist as long following diagnosis as GAD and are less common in patients who are diagnosed with type 1 diabetes over the age of 30 years. They are therefore less useful than GAD for characterising diabetes in longer term older patients.

Tested alongside Anti-GAD and Anti-ZnT8.

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Anti-Glutamic Acid Decarboxylase Antibody

Special instructions for collection

Serum samples only please.

How to request

​Trak, ICE, Clinical Immunology request form.

Diabetic screen tests can only be requested via Hospital referrals.

Availability

​Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround
21 Days
 
 
What happens if the result is positive or abnormal

General additional information

​Diagnosis of Type 1 Diabetes Mellitus.

Tested alongside Anti-IA2 and Anti-ZnT8

Two forms of GAD, known as GAD65 and GAD67, are recognised. The current assay recognises antibodies to GAD65 which are found in T1DM and approximately 60% of patients with stiff-person syndrome.

 

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9ml

Additive - Adult 1

​Clotting activator/gel

Thyroid Peroxidase Antibodies

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

Normal working hours 9am-5pm Mon to Fri

Anticipated turnaround
14 Days
 
 
What happens if the result is positive or abnormal

General additional information

Circulating thyroid autoantibodies have been widely implicated in the aetiology of autoimmune thyroid diseases.  Autoantibodies to various thyroid antigens have been detected in a range of thyroid dysfunctions including chronic thyroiditis, nontoxic goitre, Hashimoto’s thyroiditis and Graves disease. 

Approximately 2% of the population of Europe and North America are affected with autoimmune thyroid disease. Autoimmune thyroid diseases are 5 to 10 times more common in women than men.

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

dsDNA

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround
2 weeks (10 working days)
 
These TaTs are currently under review and may change.
What happens if the result is positive or abnormal

Reviewed and authorised by Consultant Immunologist.

General additional information

​An Anti-dsDNA test is often useful diagnostically for patients who have antinuclear antibodies or clinical findings suggestive of SLE. the presence of Anti-dsDNA is one of the American Rheumatism Association criteria for SLE and the antibody is rarely found in high levels in patients with other connective tissue diseases. However Anti-dsDNA antibodies may also be seen in patients with overlap symptoms between SLE and other autoimmune diseases, as well as in autoimmune liver disease.

Container_Child1
Volume - Child 1

​Minimum 1ml

Additive - Child 1

​None

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Gel

Glomerular Basement Membrane Antibody

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

Normal working hours 9am-5pm Mon-Fri.

Anticipated turnaround
Urgent same day/next day service available. Sample must be received in the lab by 1pm Mon and Fri. Prior notice must be given before a sample is sent.
 
Non urgent samples 7 Days.
What happens if the result is positive or abnormal

Reviewed and authorised by Consultant Immunologist.

Any urgent results are telephoned directly to the requesting clinician.

If 'new' positive the result is given to the Consultant Immunologist or Registrar

 

General additional information

​Diagnosis of Goodpasture's Syndrome

Anti-GBM antibodies are found in the sera of the majority (>90%) of patients with Goodpasture's syndrome. The diagnosis must be confirmed by renal biopsy. They are also occasionally found in ANCA-associated disease, usually with MPO-ANCA but very rarely with PR3-ANCA.

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

4.9mls

Additive - Adult 1

​Clotting activator/gel

Anti-Neutrophil Cytoplasmic Antibody

Special instructions for collection

Serum samples only please.

How to request

​By prior arrangement, email the Immunology lab on ImmunologyLabs@nhslothian.scot.nhs.uk

Availability

Normal working hours 9am-5pm Mon-Fri. For urgent requests please see Anti-PR3 and Anti-MPO.

Anticipated turnaround

21 Days

What happens if the result is positive or abnormal

Reviewed and authorised by Consultant Immunologist.

General additional information
ANCA's are measured by IIF. 
 
Positive ANCA with MPO or PR3 specificity is strongly suggestive of ANCA associated vasculitis. Clinical correlation is advised along with confirmation of diagnosis histologically (tissue biopsy) wherever possible. Depending on the clinical scenario, urgent treatment may be warranted (by way of immune suppression therapy/therapeutic plasmapheresis).
 
Negative ANCA does not exclude vasculitis, and if there is clinical concern about vasculitis a tissue biopsy for histological diagnosis remains the gold standard.
Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Anti-Myeloperoxidase Antibody

Special instructions for collection

Serum samples only please.

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

Normal working hours are 9am-5pm Mon-Fri.

Anticipated turnaround
Urgent same day/next day service available. Sample must be received in the laboratory by 1pm Mon-Fri. Prior to sending a sample the lab must be contacted.
 
Non urgent samples 7 Days.

What happens if the result is positive or abnormal

Reviewed and authorised by Consultant Immunologist.

Any urgent results are telephoned directly to the requesting clinician.

 If 'new' positive, the result is given to the Consultant Immunologist or Registrar to contact the requesting clinician.

General additional information

​This test is performed in conjunction with Anti-PR3.

Positive MPO specificity is strongly suggestive of ANCA associated vasculitis. Clinical correlation is advised along with confirmation of diagnosis histologically (tissue biopsy) wherever possible. Depending on the clinical scenario, urgent treatment may be warranted (by way of immune suppression therapy/therapeutic plasmapheresis).

Negative ANCA does not exclude vasculitis, and if there is clinical concern about vasculitis a tissue biopsy for histological diagnosis remains the gold standard for diagnosis.

 

Volume - Child 1

4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

​4.9mls

Additive - Adult 1

​Clotting activator/gel

Anti-Proteinase 3 Antibody

How to request

​Trak, ICE, Clinical Immunology request form.

Availability

Normal working hours ​9am - 5pm Mon-Fri

Anticipated turnaround
Urgent same day/next day service available. sample must be received in lab by 1pm Mon-Fri. Prior to sending a sample the lab must be contacted.
 
Non urgent samples 7 Days.
 
What happens if the result is positive or abnormal

Reviewed and authorised by Consultant Immunologist. 

Any urgent results are telephoned directly to the requesting clinician.

If 'new' positive, the result is given to the Consultant Immunologist or Registrar to contact the requesting clinician.

General additional information

​This test is performed in conjuction with Anti-MPO

Positive PR3 specificity is strongly suggestive of ANCA associated vasculitis. Clinical correlation is advised along with confirmation of diagnosis histologically (tissue biopsy) wherever possible. Depending on the clinical scenario, urgent treatment may be warranted (by way of immune suppression therapy/therapeutic plasmapheresis)

Negative ANCA does not exclude vasculitis, and if there is clinical concern about vasculitis a tissue biopsy for histological diagnosis remains the gold standard for diagnosis.

Volume - Child 1

​4.9ml

Additive - Child 1

​Clotting activator/gel

Volume - Adult 1

4.9ml

Additive - Adult 1

​Clotting activator/gel

HIV RNA Quantitative PCR

Transport arrangements

​Inter-site van shuttle service, GP van service, External hospital van service, Couriers, Hospital porter collection (refer to collection times posted in wards/ departments), Hospital Pneumatics Tube System (PTS).

Sample storage arrangements

Specimen transport arrangements must be in accordance with current postal and transport regulations. Samples should be transported to the laboratory without delay. If processing is delayed, refrigeration at 2-8 oC is preferable to storage at room temperature for all samples, with the exception of EDTA blood samples. EDTA blood samples must be stored at room temperature (19-23 oC). Patient samples can be transported at ambient temperature.

Special instructions for collection

​Clinical samples must be collected into leak-proof containers and placed into a sealed bag with absorbent material. Patient samples must be individually packaged and not mixed with other patient samples. Any appropriate hazard labelling should be clearly visible on the sample bag / sample.

How to request

Use appropriate TRAK or ICE barcode labels which include Patient Identifier Number (CHI), Forename, Surname, Date of Birth, Gender and Location of patient (hospital and ward or primary care centre). Use Virology Request Form only if TRAK or ICE ordering system is unavailable.

Availability

​Weekdays 08.30-17.00

Anticipated turnaround

7 days

What happens if the result is positive or abnormal

Results are available in the patient’s records.

Static information/disclaimer

​False negative results may occur for a variety of reasons including: inappropriate timing of sample collection, inappropriate sample type, inappropriate sample storage and presence of virus below the detectable limit of the assay. New and emerging variants may also occur which may not be detected by specific assays. Towards the limit of detection of an assay sampling variation will result in lower reproducibility. Haemolysed or lipaemic samples can also cause interference with assay results.

General additional information

​Samples tested twice per week on a Monday and Thursday.

Testing will not be performed with out a completed form- Combined HIV Immunological and Viral Load Request Form.pdf

 

Please contact virologyadvice@nhslothian.scot.nhs.uk for all non-urgent clinical enquiries.

Container_Adult1
Volume - Adult 1

​9ml blood

Parechovirus PCR

Transport arrangements

​Inter-site van shuttle service, GP van service, External hospital van service, Couriers, Hospital porter collection (refer to collection times posted in wards/ departments), Hospital Pneumatic Tube System (PTS)

Sample storage arrangements

Specimen transport arrangements must be in accordance with current postal and transport regulations. Samples should be transported to the laboratory without delay. If processing is delayed, refrigeration at 2-8 oC is preferable to storage at room temperature for all samples, with the exception of EDTA blood samples. EDTA blood samples must be stored at room temperature (19-23 oC). Patient samples can be transported at ambient temperature.

Special instructions for collection

​Clinical samples must be collected into leak-proof containers and placed into a sealed bag with absorbent material. Patient samples must be individually packaged and not mixed with other patient samples. Any appropriate hazard labelling should be clearly visible on the sample bag / sample.

How to request

Use appropriate TRAK or ICE barcode labels which include Patient Identifier Number (CHI), Forename, Surname, Date of Birth, Gender and Location of patient (hospital and ward or primary care centre). Use Virology Request Form only if TRAK or ICE ordering system is unavailable.

Availability

​Weekdays 08.30-17.00

Weekend 08:30 - 16:00

Anticipated turnaround

​4 days

What happens if the result is positive or abnormal

Positive results are notified to the Duty Virologist and are available in the patient’s records.

Static information/disclaimer

​False negative results may occur for a variety of reasons including: inappropriate timing of sample collection, inappropriate sample type, inappropriate sample storage and presence of virus below the detectable limit of the assay. New and emerging variants may also occur which may not be detected by specific assays. Towards the limit of detection of an assay sampling variation will result in lower reproducibility. Haemolysed or lipaemic samples can also cause interference with assay results.

General additional information

​Please contact virologyadvice@nhslothian.scot.nhs.uk for all non-urgent clinical enquiries.

Volume - Child 1

​Grape sized amount of faeces taken into Sterile Stool Container

Volume - Child 2

​CSF taken into Sterile Universal Container

Volume - Child 3

Throat swab

Volume - Adult 1

​Grape sized amount of faeces taken into Universal Stool Container

Volume - Adult 2

​CSF taken into Sterile Universal Container

Volume - Adult 3

Throat swab

Legionella Urinary Antigen Testing

Transport arrangements

Useful: in adult patients hospitalised with severe pneumonia, where preferred sputum or BAL samples are unavailable.

Transport as soon as is practicable. (within 24 hours).

Sample storage arrangements

If delay in transporting, store in the fridge (4-6°C).

 

Special instructions for collection

A sputum or BAL sample for the respiratory pathogen PCR panel (which includes Legionella) is the preferred sample for diagnosis as it includes several differential diagnoses. However, sputum or BAL may not always be available, and therefore urinary antigen testing may be appropriate. Do not send in boric acid containers; they cannot be processed. Specimens will only be tested for Legionella urinary antigen if the patient meets at least one of the following criteria:
• Intensive Care patient
• Immuno-compromised/suppressed patient
• CURB65 score ≥3
• Recent foreign travel
• Spa exposure

How to request

Via Trak ("Legionella Urinary Ag Profile") or by request form, or GP comms.

Availability

0900-1700 (RIE + SJH)

Anticipated turnaround

2 days

What happens if the result is positive or abnormal

Telephoned by microbiologist.

Static information/disclaimer

​Suitable for detection of Legionella pneumophila serogroup 1 antigen only

General additional information

​Clinical indication for test:

Adult patient hospitalised with severe pneumonia in NHS Lothian.


A sputum or BAL sample for the respiratory pathogen PCR panel (which includes Legionella) is the preferred sample for diagnosis as it includes several differential diagnoses. However, sputum or BAL may not always be available, and therefore urinary antigen testing may be appropriate.

Specimens will only be tested for Legionella urinary antigen if the patient meets at least one of the following criteria:
• Intensive Care patient
• Immuno-compromised/suppressed patient
• CURB65 score ≥3
• Recent foreign travel
• Spa exposure

Please contact virologyadvice@nhslothian.scot.nhs.uk for all non-urgent clinical enquiries.

Volume - Adult 1

Ur​ine taken into Sterile Universal Container

Iron Regulation Genetic Testing

Transport arrangements

​Lab van or 1st class post

Sample storage arrangements

Refrigerate - DO NOT FREEZE. For additional sample packaging and transport information see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

Anticipated turnaround
Static information/disclaimer

This test is currently unaccredited to ISO 15189. 

General additional information

For referral criteria and gene list please see SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

An information sheet is also available for this test: https://services.nhslothian.scot/geneticservice/molecular-genetic-test-information-sheets/

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Volume - Child 1

1ml

Volume - Child 2

1ml

Volume - Adult 1

3ml

Volume - Adult 2

3ml

Factor XI Deficiency Genetic Testing

Transport arrangements

​Lab van or 1st class post

Sample storage arrangements

Refrigerate - DO NOT FREEZE. For additional sample packaging and transport information see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

How to request

Molecular Haematology request form available via

https://services.nhslothian.scot/geneticservice/request-forms/

Anticipated turnaround
Static information/disclaimer

This test is currently unaccredited to ISO 15189. 

General additional information

For referral criteria and gene list please see SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

Volume - Child 2

1ml

Volume - Adult 2

3ml

Helicobacter pylori antigen (faeces)

Transport arrangements

Useful in:

  • patients with uncomplicated dyspepsia unresponsive to lifestyle change and antacids, following a single one month course of proton pump inhibitor (PPI), without alarm symptoms.
  • patients with a history of gastric or duodenal ulcer/bleed who have not previously been tested.
  • Patients before taking NSAIDs, if they have a prior history of gastro-duodenal ulcers/bleeds. (See Test and treat for Helicobacter pylori (HP) in dyspepsia PHE Guidance)

Transport as soon as is practicable.

 

Sample storage arrangements

If delay in transporting, store in the fridge (4-6°C).

Special instructions for collection

Sample must be received in the laboratory within 48 hours of collection- so preferably don't collect on a Friday. Do not overfill the container. 

How to request

GP comms, or via Trak ("Helicobater antigen profile (All sites))" or by request form.

Availability

 

0900-1700 (SJH) Monday - Friday. Samples batched and run 3 times per week.

 

Anticipated turnaround

Up to 6 days

General additional information

The patient should not have had any antibiotics in the previous 4 weeks, or proton pump inhibitors in the previous 2 weeks, to avoid false negatives. Do not routinely offer re-testing after eradication

Resources

PHE Guidance

Refhelp Guidance

Lothian Joint Formulary

 

Volume - Child 1

1-5ml

Volume - Adult 1

1-5 ml

Alpha 1 Antitrypsin Deficiency Genetic Testing

Transport arrangements

Lab van or 1st class post

Sample storage arrangements

​Refrigerate - DO NOT FREEZE. For additional sample package and transport see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

Anticipated turnaround
Static information/disclaimer

This test is currently unaccredited to ISO 15189. 

General additional information

For referral criteria and gene list please see the SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

 

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Volume - Child 1

1ml

Volume - Child 2

1ml

Volume - Adult 1

3ml

Volume - Adult 2

3ml

Porphyrin - Erythrocyte

Special instructions for collection

Protect sample from light by covering with aluminium foil

Anticipated turnaround

​28 days

General additional information

Samples from RIE, SJH and RHCYP will be sent via WGH.

Clinical testing strategy can be found here:

 

 

Further information for referring labs can be found here.

 

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Volume - Child 1

​1.0 mL

Volume - Adult 1

1.0 mL

Urinary Cannabinoid

Anticipated turnaround

7 days

General additional information

Reported as positive or negative. Cannabinoid (cannabis) is no longer part of the drugs-of-abuse test profile and should be requested separately. This can be done on the same sample as drugs of abuse.

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Volume - Adult 1

5 mls

Sirolimus

Special instructions for collection

​Collect sample just before next dose.

Please note, only Sarstedt 1.2 mL or 2.6 mL EDTA tubes, or BD Vacutainer 4 mL EDTA tubes, will be accepted.

Availability

Samples analysed in batches twice per day Mon – Fri.

Samples received before 10am will normally be reported by 2pm.

Samples received before 2pm will normally be reported same day.

 

Samples analysed on a Sat morning by prior arrangement only with the Duty Biochemist and must be received by 10am.

Anticipated turnaround

​3 days

General additional information

Therapeutic range varies with time post-transplant.

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Volume - Child 1

​0.5 ml

Volume - Adult 1

1.0 ml

AST:ALT Ratio

Anticipated turnaround

1 day

General additional information

​Indicated for the work-up of asymptomatic abnormal LFTs. >1.0 Abnormal AST:ALT Ratio; may indicate fibrosis / cirrhosis. Consider GI referral.

This test is not valid if increased AST is from non-hepatic source such as muscle or red cells.

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Volume - Adult 1

0.2 ml

Transfusion Reaction Investigation

Transport arrangements
​Samples MUST be received IMMEDIATELY after collection
Sample storage arrangements
Store at 4oC​
Special instructions for collection
​Venesection of the sample must be AWAY from the site of blood infusion.
 

NHS Lothian operates a Zero Tolerance approach in relation to blood sample acceptance criteria. Errors in patient identification and sample labelling may lead to ABO-incompatible transfusions.

The demographics on the samples MUST be hand written, legible and MUST match exactly to the accompanying request form. Samples labelled with an addressograph or where evidence of an addressograph have been attached will be discarded. Samples with errors or where patient core identifiers have been obliterated will be discarded.

Sample Labelling

The following patient identifying data and sampler signature is mandatory -

  • CHI number (or Hospital Number where no CHI number is available - See CHI exceptions)*
  • Surname
  • Forename
  • Date of Birth
  • Signature

Sample Labelling for Unknown Patients

  • Surname / Forename = UNKNOWN
  • Temporary Identification Number = beginning with 700
  • Gender
  • Sample dated and signed

Once patients details become known, a new sample must be sent to the laboratory

Request Form Labelling

Addressograph labels are acceptable for request forms. If the form is handwritten then the information must be clear, legible and MUST contain the following data identifiers -

  • Surname
  • Forename
  • Date of Birth
  • CHI Number (See CHI exceptions)*
  • Name and signature of the person taking the sample
  • Name of the requesting clinician. (For component requests, this is the Doctor or authorised Nurse that has prescribed the transfusion)
  • Clinical details are desirable but are not essential

*CHI Exceptions

Not all patients will have a CHI number. If the patient is a genuine CHI exception then the Hospital number is acceptable and MUST be used. A CHI number may not be available in the following circumstances -

  • Foreign visitors
  • Patients from England, Wales and Ireland
  • Patients not registered with a GP in Scotland
  • Patients currently remanded within Her Majesty's Prisons
  • Patients in the armed forces
  • Newborn infants <3 days old.

A MINIMUM of 2.0ml of blood is required for adult specimens.

How to request

​If a transfusion reaction is suspected then stop the transfusion immediately and contact the Blood Transfusion Laboratory for advice. The Biomedical Scientist will instruct on how to proceed. All suspected transfusion reactions must be discussed with the Haematology Registrar (contact via switchboard). The registrar will decide whether a full Transfusion Reaction Investigation is warranted.

All Transfusion Reaction Investigation requests must be made via request form

  • Obtained from the Blood Transfusion Laboratory (WGH / SJH)
Availability
​No restrictions: A Transfusion Reaction Investigation will be carried out at any time, where deemed appropriate by the Haematology Registrar.
Anticipated turnaround
​Dependant on complexity of the investigation.
What happens if the result is positive or abnormal
​If the Transfusion Reaction Investigation is 'Positive', the Haematology Registrar will be informed, who will then contact the referring doctor and discuss how best to proceed. Please provide a telephone / bleep number.
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Volume - Child 1

​4.5ml

Additive - Child 1

​EDTA

Volume - Adult 1

​4.5ml

Additive - Adult 1

​EDTA

Mycoplasma pneumoniae PCR

Transport arrangements

​Inter-site van shuttle service, GP van service, External hospital van service, Couriers, Hospital porter collection (refer to collection times posted in wards/ departments), Hospital Pneumatic Tube System (PTS).

Sample storage arrangements

Specimen transport arrangements must be in accordance with current postal and transport regulations. Samples should be transported to the laboratory without delay. If processing is delayed, refrigeration at 2-8 oC is preferable to storage at room temperature for all samples, with the exception of EDTA blood samples. EDTA blood samples must be stored at room temperature (19-23 oC). Patient samples can be transported at ambient temperature.

Special instructions for collection

​Clinical samples must be collected into leak-proof containers and placed into a sealed bag with absorbent material. Patient samples must be individually packaged and not mixed with other patient samples. Any appropriate hazard labelling should be clearly visible on the sample bag / sample.

How to request

Use appropriate TRAK or ICE barcode labels which include Patient Identifier Number (CHI), Forename, Surname, Date of Birth, Gender and Location of patient (hospital and ward or primary care centre). Use Virology Request Form only if TRAK or ICE ordering system is unavailable.

Availability

​Weekdays 08.30 - 17.00

Weekends 09.00 - 16.00

Anticipated turnaround

​7 days

What happens if the result is positive or abnormal

The duty microbiologist will contact the clinical team to discuss the result and any infection control related issues where appropriate.

Static information/disclaimer

​False negative results may occur for a variety of reasons including: inappropriate timing of sample collection, inappropriate sample type, inappropriate sample storage and presence of virus below the detectable limit of the assay. New and emerging variants may also occur which may not be detected by specific assays. Towards the limit of detection of an assay sampling variation will result in lower reproducibility. Haemolysed or lipaemic samples can also cause interference with assay results.

General additional information

​Please contact virologyadvice@nhslothian.scot.nhs.uk for all non-urgent clinical enquiries.

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Volume - Child 1

​Throat Swab

Volume - Child 2

B​ronchoalveolar lavage taken into Sterile Universal Container

Volume - Child 3

​Nasopharyngeal Secretions taken into Sterile Conical Centrifuge Tube

Volume - Adult 1

​Throat swab

Volume - Adult 2

​Bronchoalveolar lavage taken into Sterile Universal Container

Volume - Adult 3

​Induced sputum taken into Sterile Universal Container

Air Sampling

Transport arrangements

Air Sampling is for infection control purposes. Please see Air Sampling SOP on Infection Control intranet site. (SOP on infection control website - need sent on specific form at back of SOP from theatre) 

Special instructions for collection

Please arrange through the Infection Control Team. Agar plates need sealed all the way round and to be in date. 

How to request

Please contact the Infection Control Team.

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Vomit - Routine C & S

Transport arrangements

There is no clinical utility in sending vomitus for bacterial culture and sensitivities. Please consider whether virological testing for Norovirus etc. would be useful instead.

Special instructions for collection

Not suitable for general bacteriological investigation. 

Availability

Not processed by bacteriology.

General additional information

Not processed by bacteriology. Do not send.

Carbapenemase-producing Enterobacteriaceae (CPE or CRE) screening

Transport arrangements

Useful: In patients identified as being at higher risk for CPE colonisation as per HPS clinical risk assessment (inpatient outside of Scotland in last 12 months, patients who have received holiday dialysis outside Scotland in the last 12 months, or patients who have been close contact with someone colonised or infected with CPE in the last 12 months)

Transport as soon as is practicable.

Sample storage arrangements

Store at 4-6oC

Special instructions for collection
A rectal swab should be taken using a routine bacteriology swab by inserting the swab into the rectum and rotating it gently, making sure faecal material is visible on the swab. The swab should then be put back into the transport medium container and sent to the microbiology laboratory for testing.
 
If it is not possible to take a rectal swab, a stool sample can be collected instead. The stool sample should be collected in the same way as for routine culture.
 
Patients with wounds or lesions should also have these swabbed and patients with a urinary catheter should have a catheter specimen of urine sent for testing.  Rectal swabs are not suitable sample types for children and babies - please submit a stool specimen.
 
Routine culture of swabs and stool may miss these organisms - please take separate samples and send specifically for CPE screen.
How to request

Via Trak ("CPE Scren RIE/WGH/RHSC") or via request form, or GP comms, stating clearly for CPE screen.

Availability

24 hours (RIE), 0900-1700 (SJH)

Anticipated turnaround

Up to 5 days

What happens if the result is positive or abnormal

Electronically available.

General additional information

Patients who are identified as high risk should be managed as if CPE positive and should be isolated in a single room, preferably with en-suite facilities, until the result of the test is known. It is essential to consistently apply SICPs and contact TBPs as set out in the National Infection Prevention and Control Manual. 

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Volume - Child 1

​2-3mls

Volume - Adult 2

​2-3mls

Femoral Head - Routine C & S

Transport arrangements

Transport as soon as practicable

Sample storage arrangements

Store at 4-6oC

Special instructions for collection

Place in appropriate sterile container WITHOUT ADDITIVE

How to request

Via TRAK or yellow request form

Availability

RIE : 9 am to 8 pm daily. SJH : Mon - Friday 9am - 5pm. Sat - Sun 9 am - 12 nn

Anticipated turnaround

5 days

What happens if the result is positive or abnormal

Telephoned by Microbiologist

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Additive - Adult 1

NONE

Heart Valves (native or artificial) - Routine M, C & S

Transport arrangements

Useful: In patients with suspected bacterial or fungal native or prosthetic valve endocarditis.

Transport as soon as is practicable.

Sample storage arrangements

If delay in transporting, store in the fridge (4-6°C).

Special instructions for collection

Do not add preservative. Any sterile container is an acceptable alternative to a Universal

How to request

Via Trak (C&S - Tissue) or request form.

Availability

0900-2000 (RIE), 0900-1700 (SJH)

Anticipated turnaround

Up to 5 days

What happens if the result is positive or abnormal

Telephoned by microbiologist.

General additional information

Valve tissue can be sent to Great Ormond Street for bacterial 16s RNA PCR and/or fungal 18s RNA PCR. Please discuss with Microbiology medical staff.

Additive - Child 1

NONE

Additive - Adult 1

NONE

Semen for Routine C & S

Transport arrangements

Useful: In specific patients suspected of having chronic bacterial prostatitis. Urine for M, C, S may be of more utility in acute prostatitis.

Transport as soon as is practicable

Sample storage arrangements

If delay in transporting, store in the fridge (4-6°C).

Special instructions for collection

Single total ejaculate required.

How to request

GP order comms or via Trak ("C&S - Fluids" then specify specimen type "Semen")

Availability

24 hours (RIE), 0900-1700 (SJH)

Anticipated turnaround

Up to 5 days

What happens if the result is positive or abnormal

Telephoned by microbiologist.

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Volume - Child 1

As adult

Volume - Adult 1

0.5 to 10 ml

Oesophageal Brushings - Mycology

Transport arrangements

As soon as practicable

Sample storage arrangements

Store at 4-6oC

How to request

Via TRAK or yellow request form

Availability

Mon-Fri 9am to 5pm.

Anticipated turnaround

20 days

What happens if the result is positive or abnormal

Telephoned by Microbiologist

Haemophilia B Genetic Testing

Transport arrangements

Lab van or 1st class post

Sample storage arrangements

Refrigerate - DO NOT FREEZE. For additional sample packaging and transport information see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

How to request

Molecular Haematology request form available via

https://services.nhslothian.scot/geneticservice/request-forms/

Anticipated turnaround
Static information/disclaimer

This test is currently unaccredited to ISO 15189. 

General additional information

For referral criteria and gene list please see SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

Volume - Child 2

1ml

Volume - Adult 2

3ml

Common Craniosynostosis Syndromes Genetic Testing

Transport arrangements

Lab van or 1st class post

Sample storage arrangements

Refrigerate - DO NOT FREEZE. For additional sample packaging and transport information see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

Anticipated turnaround
Static information/disclaimer

This test is currently unaccredited to ISO 15189. 

General additional information

For referral criteria and gene list please see SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

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Volume - Child 1

1ml

Volume - Child 2

1ml

Volume - Adult 1

3ml

Volume - Adult 2

3ml

Myotonic Dystrophy Type 1 (DM1) Genetic Testing

Transport arrangements

Lab van or 1st class post

Sample storage arrangements

Refrigerate - DO NOT FREEZE. For additional sample packaging and transport information see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

Anticipated turnaround
Static information/disclaimer

This test is currently accredited to ISO 15189. 

General additional information

For referral criteria and gene list please see SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

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Volume - Child 1

1ml

Volume - Child 2

1ml

Volume - Adult 1

3ml

Volume - Adult 2

3ml

Juvenile Polyposis Genetic Testing

Transport arrangements

Lab van or 1st class post

Sample storage arrangements

Refrigerate - DO NOT FREEZE. For additional sample packaging and transport information see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

How to request

Referrals should include a Colorectal cancer gene panel proforma 

https://services.nhslothian.scot/geneticservice/request-forms/

Anticipated turnaround
Static information/disclaimer

This test is currently unaccredited to ISO 15189. 

General additional information

For referral criteria and gene list please see SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

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Volume - Child 1

​1ml

Volume - Child 2

1ml

Volume - Adult 1

3ml

Volume - Adult 2

3ml

Ornithine Transcarbamulase Deficiency (OTC) Genetic Testing

Transport arrangements

Lab van or 1st class post

Sample storage arrangements

Refrigerate - DO NOT FREEZE. For additional sample packaging and transport information see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

Anticipated turnaround
Static information/disclaimer

This test is currently unaccredited to ISO 15189. 

General additional information

For referral criteria and gene list please see SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

An information sheet is also available for this test: https://services.nhslothian.scot/geneticservice/molecular-genetic-test-information-sheets/

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Volume - Child 1

1ml

Volume - Child 2

1ml

Volume - Adult 1

3ml

Volume - Adult 2

3ml

Male Infertility (CFTR) Genetic Testing

Transport arrangements

Lab van or 1st class post

Sample storage arrangements

Refrigerate - DO NOT FREEZE. For additional sample packaging and transport information see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

Anticipated turnaround
Static information/disclaimer

This test is currently accredited to ISO 15189. 

General additional information

For referral criteria and gene list please see SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

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Container_Child1
Volume - Child 1

​1ml

Volume - Child 2

1ml

Volume - Adult 1

3ml

Volume - Adult 2

3ml

Huntington Disease-Like Disorders Genetic Testing

Transport arrangements

Lab van or 1st class post

Sample storage arrangements

Refrigerate - DO NOT FREEZE. For additional sample packaging and transport information see https://services.nhslothian.scot/geneticservice/sample-requirements-for-dna-tests/

Anticipated turnaround
Static information/disclaimer

The sanger sequencing component of this test is currently unaccredited to ISO 15189.

General additional information

For referral criteria and gene list please see SSNGM Rare & Inherited Test Directory https://www.nss.nhs.scot/publications/ssngm-rare-and-inherited-disease-test-directory/

Container_Adult1
Container_Child1
Volume - Child 1

​1ml