Department of Pathology, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
Cancer Cytopathol. 2014 Mar;122(3):167-74. doi: 10.1002/cncy.21372. Epub 2013 Nov 20.
Determining high-risk human papillomavirus (HR-HPV) status of head and neck squamous cell carcinoma (HNSCC) defines a tumor subset with important clinical implications. Cytologic sampling often provides the sentinel or sole diagnostic specimen. The authors assessed the performance characteristics for the Roche cobas 4800 HPV real-time polymerase chain reaction (PCR)-based system (cobas) on cytologic specimens of HNSCC compared with standard methods of in situ hybridization (ISH) for HR-HPV and immunohistochemistry (IHC) for p16 on formalin-fixed, paraffin-embedded (FFPE) tissue.
Samples of HNSCC were collected by fine-needle aspiration and from surgical biopsies or resections, fixed, and processed with the cobas system. Available corresponding FFPE samples were synchronously evaluated for HR-HPV using ISH and IHC. Discrepant cases underwent additional PCR studies for adjudication.
Thirty-six samples from 33 patients were analyzed. Forty-two percent (n = 15) of tumors were positive for HR-HPV according to cobas. Corresponding histology with ISH (n = 30) was concordant in 91% of samples. Compared with the adjudication PCR standard, there were 3 false-positive cases according to cobas. Ninety-two percent (n = 12) of cases were the HPV16 subtype. The overall sensitivity for the cobas system was 100%, and the specificity was 86%.
Concordance in HNSCC HR-HPV status between cobas and ISH/IHC was > 90%, and cobas demonstrated a sensitivity of 100% and a specificity of 86%, broadening options for HR-HPV testing of fine-needle aspiration samples. Advantages for this system include subtyping of HR-HPV and the ability to discern HR-HPV status earlier in a patient's treatment course.
确定头颈部鳞状细胞癌（HNSCC）中的高危型人乳头瘤病毒（HR-HPV）状态定义了具有重要临床意义的肿瘤亚组。细胞学采样通常提供哨或唯一的诊断标本。作者评估了罗氏 cobas 4800 HPV 实时聚合酶链反应（PCR）系统（cobas）在 HNSCC 细胞学标本上的性能特征，与 HR-HPV 的原位杂交（ISH）和福尔马林固定、石蜡包埋（FFPE）组织上的 p16 免疫组化（IHC）的标准方法进行比较。
通过细针抽吸和手术活检或切除收集 HNSCC 样本，固定，并使用 cobas 系统进行处理。同时对可用的 FFPE 样本进行 HR-HPV 的 ISH 和 IHC 评估。有差异的病例进行额外的 PCR 研究以裁决。
分析了 33 名患者的 36 个样本。根据 cobas，42%（n=15）的肿瘤为 HR-HPV 阳性。与 ISH（n=30）相对应的组织学在 91%的样本中是一致的。与裁决 PCR 标准相比，根据 cobas 有 3 例假阳性病例。92%（n=12）的病例为 HPV16 亚型。cobas 系统的总灵敏度为 100%，特异性为 86%。
cobas 与 ISH/IHC 之间在 HNSCC HR-HPV 状态上的一致性>90%，cobas 显示出 100%的灵敏度和 86%的特异性，扩大了细针抽吸样本中 HR-HPV 检测的选择。该系统的优势包括 HR-HPV 的亚分型和更早识别患者治疗过程中 HR-HPV 状态的能力。
