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

• DOI: 10.1007/s12105-024-01628-3
• Publication Date: 2024-03-27T13:03:37Z
• Authors: Hani Ibrahim Channir; Simone Kloch Bend...; Linea Cecilie Mel...; Pia Rovsing Sandholm; Christine Mordhorst; Amanda-Louise Fen...; Christian von Buc...; Katalin Kiss
• Keywords: Papillomaviridae

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