Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Copenhagen University Hospital-Rigshospitalet, Inge Lehmanns Vej 8, 2100, Copenhagen, Denmark.
Department of Pathology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.
Head Neck Pathol. 2024 Mar 27;18(1):27. doi: 10.1007/s12105-024-01628-3.
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 differ across institutions and vary in cost, detection targets, technical feasibility, and turnaround 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.
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.
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.
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 41 clinically relevant HPV types.
人乳头瘤病毒（HPV）的检测在口咽鳞状细胞癌（OPSCC）的诊断和治疗中有重要意义。HPV 检测方法和检测方案因机构而异，在成本、检测目标、技术可行性和周转时间等方面存在差异。本研究旨在使用先前应用的标准 pan-HPV DNA PCR 检测方法作为参考，验证 VisionArray® HPV 芯片在福尔马林固定和石蜡包埋（FFPE）的 OPSCC 样本中的应用。
验证队列包括先前诊断为 HPV DNA 阳性 OPSCC（n=80）、HPV DNA 阴性 OPSCC（n=21）和一组良性肿瘤样本，包括沃辛瘤（n=20）和颈外侧鳃裂囊肿（n=14）的 FFPE 组织样本。所有样本均进行 p16 免疫组化、pan-HPV DNA PCR 和 VisionArray® HPV 芯片检测。
VisionArray® HPV 芯片检测的总灵敏度和特异性分别为 100%（95%CI 95.5%；100.0%）和 96.3%（95%CI 87.3%；99.6%），阳性预测值和阴性预测值分别为 97.6%（95%CI 91.5%；99.7%）和 100%（95%CI 93.2%；100%）。
VisionArray® HPV 芯片检测可用于 OPSCC 的 FFPE 组织样本中高危型 HPV 的检测，可快速同时对 41 种临床相关 HPV 型进行基因分型。
