From the Departments of Pathology (Dr Guo, Ms Khanna, and Drs Wang, Williams, Kalhor, Gong, and Staerkel), Head and Neck Surgery (Drs Xu and Sturgis), and Epidemiology (Dr Sturgis), The University of Texas MD Anderson Cancer Center, Houston.
Arch Pathol Lab Med. 2019 Mar;143(3):356-361. doi: 10.5858/arpa.2017-0469-OA. Epub 2018 Sep 17.
CONTEXT.—: Human papillomavirus (HPV) DNA in situ hybridization (ISH) assay and p16 immunohistochemistry (IHC) are used to determine high-risk HPV status in formalin-fixed, paraffin-embedded (FFPE) tissues in oropharyngeal squamous cell carcinoma (SCC). Although high sensitivity and specificity for HPV can be obtained by combined p16 IHC and HPV DNA ISH, the occasional discrepancy between these assays has prompted evaluation of Cervista HPV assays in FFPE tissue from patients with oropharyngeal SCC.
OBJECTIVE.—: To compare the efficacy of Cervista HPV 16/18 and Cervista HPV HR assay to that of HPV DNA ISH assay and p16 IHC in FFPE tissue in head and neck squamous cell carcinoma of oropharyngeal origin.
DESIGN.—: Archived FFPE tissue from 84 patients with SCC of oropharyngeal origin and available HPV DNA ISH and p16 IHC test results were tested with the Cervista HPV 16/18 assay and further verified by polymerase chain reaction (PCR)-based HPV16/18 genotyping tests in cases with discrepancy.
RESULTS.—: Of the 84 specimens, 75% (63 of 84) were positive and 16% (13 of 84) had discrepant or equivocal findings by p16 IHC and HPV DNA ISH testing. Use of Cervista HPV assays, either to clarify discrepant/equivocal findings or as confirmation after initial p16 IHC/HPV DNA ISH tests, identified 81% (68 of 84) of HPV-positive cases without equivocal HPV results. Five of 13 cases with discrepancy or equivocal HPV DNA ISH results tested positive for HPV16 or HPV18 by Cervista HPV 16/18 assay, which was further confirmed by PCR-based HPV 16/18 genotyping.
CONCLUSIONS.—: The Cervista HPV assays are a reasonable alternative to HPV DNA ISH in determining HPV status in FFPE tissue specimens from patients with oropharyngeal SCC.
人乳头瘤病毒（HPV）原位杂交（ISH）检测和 p16 免疫组化（IHC）用于确定福尔马林固定、石蜡包埋（FFPE）的口咽鳞状细胞癌（SCC）组织中的高危 HPV 状态。虽然 p16 IHC 和 HPV DNA ISH 联合检测可获得 HPV 的高灵敏度和特异性，但这两种检测方法偶尔会出现不一致，因此需要评估 Cervista HPV 检测在口咽 SCC 患者的 FFPE 组织中的效果。
比较 Cervista HPV 16/18 和 Cervista HPV HR 检测在头颈部鳞状细胞癌起源于口咽的 FFPE 组织中的 HPV DNA ISH 检测和 p16 IHC 的效果。
对 84 例起源于口咽的 SCC 的存档 FFPE 组织进行检测，这些组织有 HPV DNA ISH 和 p16 IHC 检测结果，并使用 Cervista HPV 16/18 检测进行检测，在有差异的情况下通过聚合酶链反应（PCR）-基于 HPV16/18 基因分型检测进行进一步验证。
84 个标本中，75%（63/84）为阳性，16%（13/84）的 p16 IHC 和 HPV DNA ISH 检测结果存在差异或不确定。使用 Cervista HPV 检测，无论是为了澄清差异/不确定的发现，还是作为初始 p16 IHC/HPV DNA ISH 检测后的确认，都能确定 81%（68/84）的 HPV 阳性病例没有不确定的 HPV 结果。13 例 HPV DNA ISH 结果差异或不确定的病例中，有 5 例使用 Cervista HPV 16/18 检测呈 HPV16 或 HPV18 阳性，进一步通过基于 PCR 的 HPV 16/18 基因分型证实。
在确定口咽 SCC 患者的 FFPE 组织标本中的 HPV 状态时，Cervista HPV 检测是 HPV DNA ISH 的合理替代方法。
