Unit of Cancer Epidemiology and Belgian Cancer Centre, Scientific Institute of Public Health, Brussels, Belgium.
Department of Pathology, VU University Medical Centre, Amsterdam, The Netherlands.
Clin Microbiol Infect. 2015 Sep;21(9):817-26. doi: 10.1016/j.cmi.2015.04.015. Epub 2015 May 1.
Several countries are in the process of switching to high-risk human papillomavirus (hrHPV) testing for cervical cancer screening. Given the multitude of available tests, validated assays which assure high-quality screening need to be identified. A systematic review was conducted to answer the question which hrHPV tests fulfil the criteria defined by an international expert team in 2009, based on reproducibility and relative sensitivity and specificity compared to Hybrid Capture-2 or GP5+/6+ PCR-enzyme immunoassay. These latter two hrHPV DNA assays were validated in large randomized trials and cohorts with a follow-up duration of 8 years or more. Eligible studies citing the 2009 guideline were retrieved from Scopus (http://www.scopus.com) and from a meta-analysis assessing the relative accuracy of new hrHPV assays versus the standard comparator tests to detect high-grade cervical intraepithelial neoplasia or cancer in primary screening. The cobas 4800 HPV test and Abbott RealTime High Risk HPV test were consistently validated in two and three studies, respectively, whereas the PapilloCheck HPV-screening test, BD Onclarity HPV assay and the HPV-Risk assay were validated each in one study. Other tests which partially fulfil the 2009 guidelines are the following: Cervista HPV HR Test, GP5+/6+ PCR-LMNX, an in-house E6/E7 RT quantitative PCR and MALDI-TOF (matrix-assisted laser desorption-ionization time-of-flight). The APTIMA HPV assay targeting E6/E7 mRNA of hrHPV was also fully validated. However, the cross-sectional equivalency criteria of the 2009 guidelines were set up for HPV DNA assays. Demonstration of a low risk of CIN3+ after a negative APTIMA test over a longer period is awaited to inform us about its utility in cervical cancer screening at 5-year or longer intervals.
一些国家正在将高危型人乳头瘤病毒（hrHPV）检测用于宫颈癌筛查。鉴于有多种可用的检测方法，需要确定经过验证的检测方法，以确保高质量的筛查。我们进行了一项系统评价，旨在回答以下问题：基于与 Hybrid Capture-2 或 GP5+/6+ PCR-酶免疫测定相比的重复性和相对灵敏度和特异性，哪些 hrHPV 检测符合国际专家组 2009 年定义的标准。这两种 hrHPV DNA 检测方法都经过大型随机试验和随访时间至少 8 年的队列研究验证。从 Scopus（http://www.scopus.com）和一项评估新的 hrHPV 检测方法相对于标准比较检测方法在初级筛查中检测高级别宫颈上皮内瘤变或癌症的相对准确性的荟萃分析中检索到符合 2009 年指南的合格研究。罗氏 cobas 4800 HPV 检测和 Abbott RealTime High Risk HPV 检测分别在两项和三项研究中得到一致验证，而 PapilloCheck HPV 筛查检测、BD Onclarity HPV 检测和 HPV-Risk 检测则在各自一项研究中得到验证。其他部分符合 2009 年指南的检测方法如下：Cervista HPV HR Test、GP5+/6+ PCR-LMNX、E6/E7 RT 定量 PCR 和 MALDI-TOF（基质辅助激光解吸电离飞行时间）。针对 hrHPV E6/E7 mRNA 的 APTIMA HPV 检测也得到了全面验证。然而，2009 年指南的横断面等效性标准是为 HPV DNA 检测方法制定的。在更长的时间内，在 APTIMA 检测呈阴性后，等待低风险的 CIN3+的出现，以便告知我们其在 5 年或更长时间的宫颈癌筛查间隔中的效用。
