Evaluation of the Anyplex II HPV28 Assay in the Detection of Human Papillomavirus in Archival Samples of Oropharyngeal Carcinomas.

The improved survival and better response to treatments of human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma (OPSCC) highlight the need for effective tools in evaluating HPV status on formalin-fixed, paraffin-embedded (FFPE) cancer tissues. To date, there is no agreement regarding the most appropriate method for HPV testing on FFPE materials. We aimed to investigate the performance of the Anyplex II HPV28 (Anyplex) on FFPE OPSCC tissues and to compare it with 2 other methods for HPV-DNA detection and p16 overexpression. One hundred sixty FFPE OPSCCs were evaluated, which had already been analyzed with the INNO-LiPA HPV assay, Xpert HPV assay, and p16 immunostaining. All the samples but 1 provided valid results with the Anyplex, which showed the highest HPV detection rate and a good concordance with all the other methods (κ = 0.75, 95% CI, 0.65-0.85 versus INNO-LiPA; κ = 0.80, 95% CI, 0.70-0.89 versus Xpert; κ = 0.76, 95% CI, 0.65-0.86 versus p16). Moreover, the HPV-driven fraction, based on HPV-DNA and p16 double positivity, was higher with Anyplex (83 of 159, 52.2%) than with the other 2 assays, that is, 78 of 156 (50.0%) for INNO-LiPA and 80 of 160 (50.0%) for Xpert. Anyplex II HPV28 showed a higher HPV detection rate and HPV-associated fraction than the other methods used. This assay is suitable for HPV detection in archival OPSCC tissues.