美国病理学家学会能力验证试验中高危型人乳头瘤病毒 RNA 和 DNA 原位杂交的比较性能。
Comparative Performance of High-Risk Human Papillomavirus RNA and DNA In Situ Hybridization on College of American Pathologists Proficiency Tests.
机构信息
From the Department of Pathology and Laboratory Medicine, Walter Reed National Military Medical Center, Bethesda, Maryland (Dr Keung); Biostatistics Department (Ms Souers) and Proficiency Testing (Ms Vasalos), College of American Pathologists, Northfield, Illinois; Division of Molecular Pathology, The Translational Genomics Research Institute (TGen)/Ashion Laboratory, Phoenix, Arizona, and the Department of Pathology & Microbiology, University of Nebraska Medical Center, Omaha (Dr Bridge); the Department of Pathology, Massachusetts General Hospital, Harvard Medical School, Boston (Dr Faquin); the Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota (Dr Graham); the Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York (Dr Hameed); the Department of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee (Dr Lewis); the Departments of Pathology and Laboratory Medicine & Genetics, Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill (Dr Merker); and Office of the Director, The Joint Pathology Center, Silver Spring, Maryland (Dr Moncur).
出版信息
Arch Pathol Lab Med. 2020 Mar;144(3):344-349. doi: 10.5858/arpa.2019-0093-CP. Epub 2019 Sep 4.
CONTEXT.—: Detection of high-risk human papillomavirus (HR-HPV) in squamous cell carcinoma is important for classification and prognostication. In situ hybridization (ISH) is a commonly used HR-HPV-specific test that targets viral RNA or DNA. The College of American Pathologists (CAP) provides proficiency testing for laboratories performing HR-HPV ISH.
OBJECTIVE.—: To compare the analytical performance of RNA- and DNA-based ISH methods on CAP HR-HPV proficiency tests.
DESIGN.—: Data from the 2016-2018 CAP HPV ISH proficiency testing surveys were reviewed. These surveys consist of well-characterized samples with known status for HR-HPV, including 1 to 2 copies, 50 to 100 copies, 300 to 500 copies, and no copies of HR-HPV per cell.
RESULTS.—: Ninety-five participants submitted 1268 survey results from 20 cores. Overall, RNA ISH had a significantly higher percentage of correct responses than DNA ISH: 97.4% (450 of 462) versus 80.6% (650 of 806) ( < .001). This disparity appears to be the consequence of a superior sensitivity of RNA ISH compared to DNA ISH for samples with 1 to 2 and with 50 to 100 copies of HR-HPV per cell: 95.2% (120 of 126) versus 53.8% (129 of 240), < .001, respectively, and 100% (89 of 89) versus 76.3% (119 of 156), < .001, respectively.
CONCLUSIONS.—: An assessment of CAP HR-HPV proficiency test performance indicates that RNA ISH shows significantly higher accuracy than DNA ISH owing to higher analytical sensitivity of RNA ISH in tumors with low (1-2 copies per cell) to intermediate (50-100 copies per cell) HR-HPV viral copy numbers. These data support the use of RNA over DNA ISH in clinical laboratories that perform HR-HPV testing as part of their testing algorithms.
背景
检测高危型人乳头瘤病毒（HR-HPV）对鳞癌的分类和预后具有重要意义。原位杂交（ISH）是一种常用的 HPV 特异性检测方法，针对病毒 RNA 或 DNA。美国病理学家学会（CAP）为进行 HR-HPV ISH 的实验室提供专业能力测试。
目的
比较基于 RNA 和 DNA 的 ISH 方法在 CAP HR-HPV 专业能力测试中的分析性能。
设计
回顾了 2016-2018 年 CAP HPV ISH 专业能力测试调查的数据。这些调查包括具有 HR-HPV 已知状态的特征明确样本，包括每个细胞 1 至 2 个拷贝、50 至 100 个拷贝、300 至 500 个拷贝和无 HR-HPV 拷贝。
结果
95 名参与者提交了 20 个核心的 1268 个调查结果。总体而言，RNA ISH 的正确应答率显著高于 DNA ISH：97.4%（450/462）比 80.6%（650/806）（<0.001）。这种差异似乎是 RNA ISH 比 DNA ISH 对每个细胞 1 至 2 个拷贝和 50 至 100 个拷贝的 HR-HPV 样本具有更高灵敏度的结果：95.2%（120/126）比 53.8%（129/240）（<0.001）和 100%（89/89）比 76.3%（119/156）（<0.001）。
结论
对 CAP HR-HPV 专业能力测试性能的评估表明，由于 RNA ISH 在 HR-HPV 病毒载量较低（每个细胞 1-2 个拷贝）至中等（每个细胞 50-100 个拷贝）的肿瘤中具有更高的分析灵敏度，因此 RNA ISH 的准确性显著高于 DNA ISH。这些数据支持在进行 HR-HPV 检测的临床实验室中使用 RNA 而不是 DNA ISH，作为其检测算法的一部分。
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