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

CONTEXT.—: 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.

OBJECTIVE.—: 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.

DESIGN.—: One hundred sixty FFPE OPSCCs were evaluated, which had already been analyzed with the INNO-LiPA HPV assay, Xpert HPV assay, and p16 immunostaining.

RESULTS.—: 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.

CONCLUSIONS.—: 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.