Validation of the VisionArray® Chip Assay for HPV DNA testing in Histology Specimens of Oropharyngeal Squamous Cell Carcinoma

Abstract

Abstract Background: The detection of Human papillomavirus (HPV) has several implications in the diagnostic work-up and management of oropharyngeal squamous cell carcinoma (OPSCC). The choice of HPV detection assay and testing algorithms differs across institutions and vary in cost, detection targets, technical feasibility, and turn-around time. In this study we aimed to validate the VisionArray®HPV Chip for formalin-fixed and paraffin-embedded (FFPE) samples of OPSCC using the previously applied standard pan-HPV DNA PCR assay as a reference. Methods: The validation cohort consisted of FFPE tissue samples from patients previously diagnosed with HPV-DNA positive OPSCC (n=80), HPV-DNA negative OPSCC (n=21), and a benign group of tumor samples consisting of Warthin’s tumors (n= 20) and branchial cleft cysts of the lateral neck (n=14). All samples were tested with p16 immunohistochemistry, pan-HPV DNA PCR and the VisionArray® HPV Chip. Results: The overall sensitivity and specificity of the VisionArray® HPV Chip assay were 100% [95% CI, 95.5%;100.0 %] and 96.3% [95% CI, 87.3%;99.6%] and the positive predictive value and negative predictive value were 97.6% [95% CI, 91.5%;99.7%] and 100% [95% CI, 93.2%;100%], respectively. Conclusions: The VisionArray® HPV Chip assay can be recommended for high-risk HPV-testing in FFPE tissue samples from OPSCC, providing both a fast and simultaneous genotyping for the most common 41 clinically relevant HPV types.