SHPVRL provides Molecular HPV Testing and Genotyping services. The nature of the work-stream/request will inform the test that is applied. All assays used for clinical or epidemiological testing are CE marked.

TESTS OFFERED

A: Broad Spectrum Assays for High-Risk HPV detection

Please note that the validated biospecimen for this test is a cervical liquid-based cytology sample.

Xpert HPV Assay (Cepheid)

This assay is a qualitative DNA target amplification test based on the detection of 14 HR-HPV types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68  It is a cartridge based test for the rapid detection of individual samples. It fulfils the international criteria for use in cervical screening/disease management and is one of the HPV tests that have been approved for use within the UK Cervical Screening Programme. https://www.gov.uk/government/publications/cervical-screening-acceptable-hpv-tests

B: HPV genotyping test(s) - type specific identification of individual HPV types

Please note that the validated biospecimens for this test are cervical liquid-based cytology samples and formalin-fixed paraffin-embedded (FFPE) biopsies. Other biospecimens may be amenable to HPV genotyping, but are not formally validated nor accredited. As such, reports for these biospecimens will be accompanied by a caveat.

Allplex HPV28 Assay (Seegene)

This assay offers type specific detection of the following types including all established high-risk HPV types. It is based on target amplification of DNA. Types detected are:

High risk: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68

Intermediate/putative risk: 26, 53, 66, 69, 70, 73, 82

Low risk: 6, 11, 40, 42, 43, 44, 54, 61