Human Papillomavirus Assays Identify Risk of Cervical Cancer

The qualitative multiplex assay provides specific genotyping information for HPV Types 16 and 18, while concurrently detecting the other 12 high-risk HPV types in a pooled result. From cellular input, ß-globin is used as an internal control to assess specimen quality and identify specimens containing factors that inhibit the amplification process.

In a collaborative study, the clinical performance of the cobas 4800 HPV Test was evaluated by genotyping liquid cytology samples of 47,208 women during routine screening. The screening was carried out from May 2008 to August 2009 at 61 clinical centers across the US. The study focused on 1,578 (82.3%) of the 1,918 women who had ASC-US cytology; all 1,578 women underwent colposcopy and had valid HPV tests and cervical biopsy results. Two first generation HPV assays were compared to the second-generation cobas 4800 HPV test.

The cobas 4800 HPV Test (Roche Molecular Systems; Pleasanton, CA, USA) detected an overall prevalence rates of 32.6% with high risk HPV (14 genotypes), 8.2% with HPV-16, and 2.9% with HPV-18. The performance of the cobas 4800 HPV Test is very similar to that of the Hybrid Capture 2 test (Qiagen; Gaithersburg, MD, USA) for all standard parameters of test performance for those diagnosed with cervical intraepithelial neoplasia (CIN) 2 or worse and CIN 3 or worse end points. Both tests were highly concordant for patients characterized as less than CIN 2 and for those equal to or greater than CIN 2 with minor insignificant disagreement.

Mark H. Stoler, MD, professor of surgical pathology at the University of Virginia Health System, (Charlottesville, VA, USA), said, "Screening for high-risk HPV genotypes provides important additive information to Papanicolaou (Pap) testing. Screening for the two highest risk types, HPV-16 and HPV-18, can provide predictive information about a woman's risk for having cervical precancer or cancer." The cobas 4800 HPV Test has now been granted US Food and Drug Administration, (FDA; Silver Springs, MD, USA) approval. The study was published in March 2011, in the American Journal of Clinical Pathology.

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Roche Molecular Systems
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University of Virginia Health System