Salazar Katrina L, Duhon Daniel J, Olsen Randall, Thrall Michael
Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas.
Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas.
J Am Soc Cytopathol. 2019 Sep-Oct;8(5):284-292. doi: 10.1016/j.jasc.2019.06.001. Epub 2019 Jun 13.
The advent of US Food and Drug Administration (FDA)-approved molecular testing for human papillomavirus (HPV) has resulted in a dramatic shift from cytological testing alone to a combination of cytology and molecular testing for primary HPV screening. HPV testing has quickly become an essential component of daily practice in most laboratories and clinical practices. Although the principle of HPV testing is now familiar, it is important to understand the mechanisms behind these platforms in order to properly interpret the results and understand the limits of each method. HPV tests are more automated and reproducible than cytology, but are by no means perfect. None of these platforms will identify every HSIL/CIN2+ or cancer. This fact must be kept in mind when correlating the results of HPV testing with cytology or biopsy findings. The goal of this paper is to review the FDA- approved molecular testing platforms for HPV, including methodology, limitations, and specifications. The concordance between the platforms will also be discussed. Package inserts of the 5 FDA- approved molecular testing platforms for HPV, as well as a literature review of the platforms, were reviewed and assimilated into the article. Due to the multiple modalities available for detection of hrHPV, the concordance between these assays becomes important. Prior publications have compared HC2, Cervista, cobas, and Aptima, with most studies comparing to HC2 because it is considered the reference standard. With the newly approved BD platform, concordance studies were reviewed as well.
美国食品药品监督管理局（FDA）批准的人乳头瘤病毒（HPV）分子检测方法问世后，从单纯的细胞学检测到将细胞学与分子检测相结合用于原发性HPV筛查，这一转变意义重大。HPV检测迅速成为大多数实验室和临床实践日常工作的重要组成部分。尽管HPV检测的原理如今已为人熟知，但了解这些检测平台背后的机制对于正确解读结果和理解每种方法的局限性至关重要。HPV检测比细胞学检测更具自动化和可重复性，但绝非完美无缺。这些检测平台都无法识别出所有的高级别鳞状上皮内病变/宫颈上皮内瘤变2级及以上病变（HSIL/CIN2+）或癌症。在将HPV检测结果与细胞学或活检结果相关联时，必须牢记这一事实。本文的目的是回顾FDA批准的HPV分子检测平台，包括方法学、局限性和规格。还将讨论各平台之间的一致性。对5种FDA批准的HPV分子检测平台的包装说明书以及这些平台的文献综述进行了审查，并融入到本文中。由于有多种检测高危型HPV（hrHPV）的方法，这些检测方法之间的一致性就变得很重要。先前的出版物比较了HC2、Cervista、cobas和Aptima，大多数研究以HC2作为比较对象，因为它被视为参考标准。随着新批准的BD平台的出现，也对一致性研究进行了审查。
