Department of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Seegene Institute of Life Sciences, Seoul, South Korea.
J Clin Virol. 2014 Apr;59(4):246-9. doi: 10.1016/j.jcv.2014.01.015. Epub 2014 Jan 30.
Human papillomavirus (HPV) testing is an important part of cervical cancer screening and management of women with abnormal cytology results. The Hybrid Capture 2 (HC2) has been recommended for use as a reference test.
To evaluate a new real-time PCR assay (Anyplex II HPV28) for detecting high risk (HR) HPV and to compare it to the HC2. In addition, we compared the genotyping results of the Anyplex II HPV28 to those of sequencing analysis.
A total of 1114 cervical swab specimens were consecutively obtained from a single healthcare center. We submitted all specimens for HPV detection with Anyplex II HPV28 and HC2, then analyzed the discordant results using multiplex PCR followed by direct sequencing.
HC2 detected 72 (6.5%) cases with HR HPV, while Anyplex II HPV28 identified 138 (12.4%) cases. The overall agreement rate was 91.4% (1018/1114) of cases. Discordant results between these two assays were observed in 96 cases; 15 were positive only by HC2, and 81 were positive only by Anyplex II HPV28. Sequencing analyses performed in 80 cases of discordant results revealed 11 false-positive, and 67 false-negative results using HC2 tests and two false-positive results using Anyplex II HPV28.
The Anyplex II HPV28 assay is analytically more sensitive in the detection of the 13 HR types represented by the HC2 assay and exhibited a higher concordance with comprehensive genotyping based on the sequencing analysis, and it could be used as a laboratory testing method for identifying HPV genotypes.
人乳头瘤病毒（HPV）检测是宫颈癌筛查和异常细胞学结果女性管理的重要组成部分。杂交捕获 2 法（HC2）已被推荐作为参考检测方法。
评估一种新的实时 PCR 检测法（Anyplex II HPV28）用于检测高危型 HPV，并将其与 HC2 进行比较。此外，我们比较了 Anyplex II HPV28 的基因分型结果与测序分析的结果。
从一个单一的医疗中心连续获得了 1114 例宫颈拭子标本。我们提交了所有标本用于 Anyplex II HPV28 和 HC2 的 HPV 检测，然后使用多重 PCR 分析并直接测序分析了不一致的结果。
HC2 检测到 72 例（6.5%）高危型 HPV 阳性病例，而 Anyplex II HPV28 检测到 138 例（12.4%）阳性病例。两种检测方法的总符合率为 91.4%（1018/1114）。两种检测方法的不一致结果观察到 96 例；15 例仅 HC2 阳性，81 例仅 Anyplex II HPV28 阳性。对 80 例不一致结果进行测序分析显示，HC2 检测有 11 例假阳性，67 例假阴性，而 Anyplex II HPV28 检测有 2 例假阳性。
Anyplex II HPV28 检测法在检测 HC2 检测法所代表的 13 种高危型 HPV 方面具有更高的分析敏感性，并且与基于测序分析的综合基因分型具有更高的一致性，可作为识别 HPV 基因型的实验室检测方法。
