Department of Laboratory Medicine, Ewha Womans University School of Medicine, Seoul, Korea.
Ann Lab Med. 2012 May;32(3):201-5. doi: 10.3343/alm.2012.32.3.201. Epub 2012 Apr 18.
We evaluated the performance of various commercial assays for the molecular detection of human papillomavirus (HPV); the recently developed AdvanSure HPV Screening real-time PCR assay (AdvanSure PCR) and the Abbott RealTime High Risk HPV PCR assay (Abbott PCR) were compared with the Hybrid Capture 2 HPV DNA Test (HC2).
All 3 tests were performed on 177 samples, and any sample that showed a discrepancy in any of the 3 tests was genotyped using INNO-LiPA HPV genotyping and/or sequencing. On the basis of these results, we obtained a consensus HPV result, and the performance of each test was evaluated. We also evaluated high-risk HPV 16/18 detection by using the 2 real-time PCR assays.
Among the 177 samples, 65 were negative and 75 were positive in all 3 assays; however, the results of the 3 assays with 37 samples were discrepant. Compared with the consensus HPV result, the sensitivities and specificities of HC2, AdvanSure PCR, and Abbott PCR were 97.6%, 91.7%, and 86.9% and 83.9%, 98.8%, and 100.0%, respectively. For HPV type 16/18 detection, the concordance rate between the AdvanSure PCR and Abbott PCR assays was 98.3%; however, 3 samples were discrepant (positive in AdvanSure PCR and negative in Abbott PCR) and were confirmed as HPV type 16 by INNO-LiPA genotyping and/or sequencing.
For HPV detection, the AdvanSure HPV Screening real-time PCR assay and the Abbott PCR assay are less sensitive but more specific than the HC2 assay, but can simultaneously differentiate type 16/18 HPV from other types.
我们评估了各种用于检测人乳头瘤病毒(HPV)的商业检测方法的性能;与 Hybrid Capture 2 HPV DNA Test(HC2)相比,最近开发的 AdvanSure HPV Screening real-time PCR assay(AdvanSure PCR)和 Abbott RealTime High Risk HPV PCR assay(Abbott PCR)。
所有 3 种检测方法均在 177 个样本上进行,在 3 种检测方法中的任何一种方法出现差异的任何样本均使用 INNO-LiPA HPV 基因分型和/或测序进行基因分型。根据这些结果,我们获得了一致的 HPV 结果,并评估了每种检测方法的性能。我们还评估了 2 种实时 PCR 检测方法对高危型 HPV 16/18 的检测。
在 177 个样本中,3 种检测方法均为阴性的有 65 个,均为阳性的有 75 个;然而,37 个样本的 3 种检测方法的结果存在差异。与共识 HPV 结果相比,HC2、AdvanSure PCR 和 Abbott PCR 的灵敏度和特异性分别为 97.6%、91.7%和 86.9%和 83.9%、98.8%和 100.0%。对于 HPV 16/18 检测,AdvanSure PCR 和 Abbott PCR 检测方法之间的一致性率为 98.3%;然而,有 3 个样本存在差异(AdvanSure PCR 阳性,Abbott PCR 阴性),并通过 INNO-LiPA 基因分型和/或测序确认为 HPV 16 型。
对于 HPV 检测,AdvanSure HPV Screening real-time PCR assay 和 Abbott PCR assay 的灵敏度低于 HC2 检测,但特异性更高,而且能够同时区分 16/18 型 HPV 与其他类型。