School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
J Med Virol. 2024 Jun;96(6):e29716. doi: 10.1002/jmv.29716.
Accumulating evidence has demonstrated that high-risk human papillomaviruses (HR-HPVs) are involved in the etiology of a subset of oropharyngeal squamous cell carcinoma (OPSCC). In this regard, the International Agency for Research on Cancer (IARC) has recommended direct molecular HPV testing. So far, there is no agreement on the most appropriate method for HPV detection on OPSCC formalin-fixed paraffin-embedded (FFPE) materials. In this study, we aimed to evaluate the performance of the high-sensitive SureX HPV assay in OPSCC FFPE tissues compared with LiPA-25 and p16 immunostaining. A retrospective series of FFPE primary OPSCC cases were diagnosed between 2008 and 2019 and provided by the Henan Cancer Hospital, China. The level of agreement of two assays was determined using Cohen's Kappa (κ) statistics. A total of 230 FFPE OPSCC samples from tumor resections (n = 160) and diagnostic biopsies (n = 70) were detected. Sixty-six (28.7%) and 70 (30.4%) samples were identified as HPV-DNA-positive by LiPA-25 and SureX, respectively, of which HPV16 was largely the most common type (95.5% vs 94.3%). We found a perfect concordance between LiPA-25 and SureX for HPV-DNA status (κ = 0.906, 95% CI: 0.875-0.937) and for HPV16 (κ = 0.925, 95% CI: 0.897-0.953). In addition, SureX and p16 immunostaining had a perfect concordance (κ = 0.917, 95% CI: 0.888-0.946). Moreover, the HPV-driven fraction, based on double positivity for HPV-DNA and p16, was similar between SureX (63 of 230, 27.4%) and LiPA-25 (60 of 230, 26.1%). Similar results were found in samples from resections and biopsies. SureX and LiPA-25 are comparable. SureX could be used for routine HPV-DNA detection and genotyping on archival OPSCC FFPE tissues.
越来越多的证据表明，高危型人乳头瘤病毒（HR-HPV）与一部分口咽鳞状细胞癌（OPSCC）的病因有关。在这方面，国际癌症研究机构（IARC）建议直接进行分子 HPV 检测。到目前为止，对于福尔马林固定石蜡包埋（FFPE）的 OPSCC 标本，尚未就 HPV 检测的最适当方法达成一致意见。本研究旨在评估高敏感 SureX HPV 检测在 OPSCC FFPE 组织中的性能，与 LiPA-25 和 p16 免疫组化进行比较。回顾性系列 FFPE 原发性 OPSCC 病例于 2008 年至 2019 年由中国河南省肿瘤医院诊断，并提供了这些病例。使用 Cohen's Kappa（κ）统计确定两种检测方法的一致性程度。共检测了 230 例来自肿瘤切除（n=160）和诊断性活检（n=70）的 FFPE OPSCC 样本。LiPA-25 和 SureX 分别检测到 66（28.7%）和 70（30.4%）例 HPV-DNA 阳性，其中 HPV16 是最常见的类型（95.5% vs 94.3%）。LiPA-25 和 SureX 用于 HPV-DNA 状态（κ=0.906，95%CI：0.875-0.937）和 HPV16（κ=0.925，95%CI：0.897-0.953）的一致性非常好。此外，SureX 和 p16 免疫组化也具有完美的一致性（κ=0.917，95%CI：0.888-0.946）。此外，基于 HPV-DNA 和 p16 双阳性的 HPV 驱动分数，SureX（230 例中的 63 例，27.4%）和 LiPA-25（230 例中的 60 例，26.1%）之间相似。在来自切除和活检的样本中也发现了类似的结果。SureX 和 LiPA-25 相当。SureX 可用于常规 HPV-DNA 检测和存档 OPSCC FFPE 组织的基因分型。
