Sexually Transmitted Infection (STI) Unit, San Gallicano Dermatologic Institute, IRCCS, Via Elio Chianesi 53, 00144 Rome, Italy.
Pathology Department, Regina Elena National Cancer Institute, IRCCS, Via Elio Chianesi 53, 00144 Rome, Italy.
Oral Oncol. 2017 Sep;72:117-122. doi: 10.1016/j.oraloncology.2017.07.016.
The increasing incidence of HPV-related Oropharyngeal Squamous Cell Carcinoma (OPSCC) and the improved survival of HPV-positive OPSCC highlight the need for effective tools in evaluating HPV status on formalin-fixed paraffin-embedded (FFPE) cancers. To date, there is no agreement regarding the most appropriate method for HPV testing on FFPE materials. We aimed to investigate the performance of the Xpert® HPV assay (Cepheid) on crude lysates from OPSCC FFPE tissues.
Crude lysates were obtained by proteinase K digestion of FFPE tissues that had already been analyzed by the INNO-LiPA HPV assay and p16 immunostaining.
159 FFPE OPSCCs were evaluated. All the samples provided valid results with the Xpert, whereas three samples (1.8%) were invalid using the INNO-LiPA. Among the remaining 156 cases, 65 (41.7%) were concordantly positive and 87 (55.8%) concordantly negative (raw agreement 0.97, 95% CI: 0.93-0.99; Cohen K 0.95, 95% CI: 0.90-0.99). Type-specific data for the cases that were positive by both methods were completely concordant. Three samples were HPV16-positive with Xpert but negative with INNO-LiPA, while one OPSCC tested negative with Xpert and positive with INNO-LiPA. A very good agreement was observed between the Xpert and the p16 results, which was slightly higher than that for INNO-LiPA (Cohen K 0.87vs. 0.85).
The Xpert HPV assay appears to be a very good method for HPV detection and genotyping on FFPE OPSCCs, and requires no prior purification of nucleic acids. This assay showed a very good agreement with INNO-LiPA and p16 findings.
人乳头瘤病毒（HPV）相关口咽鳞状细胞癌（OPSCC）发病率的上升和 HPV 阳性 OPSCC 生存率的提高，突出了在福尔马林固定石蜡包埋（FFPE）癌症中评估 HPV 状态的有效工具的必要性。迄今为止，对于 FFPE 材料上 HPV 检测的最合适方法尚无共识。我们旨在研究 Xpert® HPV 检测（Cepheid）在 OPSCC FFPE 组织粗裂解物上的性能。
通过蛋白酶 K 消化已经通过 INNO-LiPA HPV 检测和 p16 免疫组化分析的 FFPE 组织获得粗裂解物。
共评估了 159 例 FFPE OPSCC。Xpert 对所有样本均提供有效结果，而 INNO-LiPA 有 3 个样本（1.8%）无效。在其余 156 例中，65 例（41.7%）为一致性阳性，87 例（55.8%）为一致性阴性（原始一致性 0.97，95%CI：0.93-0.99；Cohen K 0.95，95%CI：0.90-0.99）。两种方法均为阳性的病例的型特异性数据完全一致。Xpert 检测 3 例为 HPV16 阳性，而 INNO-LiPA 检测为阴性，1 例 OPSCC 用 Xpert 检测为阴性，用 INNO-LiPA 检测为阳性。Xpert 与 p16 结果之间观察到非常好的一致性，略高于 INNO-LiPA（Cohen K 0.87vs. 0.85）。
Xpert HPV 检测似乎是一种非常好的方法，可用于 FFPE OPSCC 上的 HPV 检测和基因分型，并且不需要事先纯化核酸。该检测与 INNO-LiPA 和 p16 结果具有非常好的一致性。
