HPV Assay Helps Laboratories to Prepare for HPV Triage Roll-Out

As the NHS cervical cancer screening programme (CSP) rolls out high risk human papilloma virus (HR-HPV) testing for the triage of women with borderline or low-grade cervical abnormalities across England, the Roche cobas HPV test has already enabled more than 30 laboratories to be ready to offer an HPV testing service.

In the financial year 2011/2012, local cervical screening programmes have been preparing to present a business case for approval and central support funding (for the first two years) to support the implementation of HPV Triage and Test of Cure. Only programmes with a minimum annual workload of 35,000 can apply and the HPV assay used must be approved by NHS CSP. Currently, only five commercially available HPV tests have been approved, including the cobas® HPV test on the cobas 4800 instrument.

The fully automated cobas® HPV Test is ideal for screening large numbers of samples for HR-HPV. Unlike other HPV assays, this is an FDA approved and CE marked test that provides a separate result for the highest risk HPV genotypes (HPV 16 and HPV 18) in addition to a pooled result for all HR-HPV genotypes. This separate simultaneous detection of HPV 16 and HPV 18 further enhances risk stratification, allowing women who may need more intensive follow up and intervention to be identified. The cobas® HPV Test is also the only integrated genotyping test to have undergone full clinical validation.

It was anticipated that 10-20 laboratories would be NHS CSP approved by 1st April 2012, from a mixture of cytology, microbiology and virology departments. This diversity of disciplines is reflected in the range of laboratories that have adopted the cobas® HPV test.

Successful bids are required to have adequate access to molecular and HPV expertise, and to maintain the operating standard of 14 day turnaround time for cervical screening. Additional criteria for local screening programmes, set by the Department of Health and NHS CSP, include: having sufficient sustainable colposcopy capacity to cope with initial increased workloads; adopting an external quality assurance programme for HPV testing; having suitable training for local professionals; appointing a pathway manager to oversee all aspects; and having quality assurance and primary care support for the bid.