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比较 Advansure 人乳头瘤病毒实时 PCR 检测、雅培实时高风险型人乳头瘤病毒检测和杂交捕获人乳头瘤病毒 DNA 检测在人乳头瘤病毒检测中的应用。

Comparison of the AdvanSure human papillomavirus screening real-time PCR, the Abbott RealTime High Risk human papillomavirus test, and the Hybrid Capture human papillomavirus DNA test for the detection of human papillomavirus.

机构信息

Department of Laboratory Medicine, Ewha Womans University School of Medicine, Seoul, Korea.

出版信息

Ann Lab Med. 2012 May;32(3):201-5. doi: 10.3343/alm.2012.32.3.201. Epub 2012 Apr 18.

Abstract

BACKGROUND

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).

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

摘要

背景

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)。

方法

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。

结果

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。

结论

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。

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