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SpeeDx PlexPCR VHS 检测法在病变拭子中用于单纯疱疹病毒、水痘带状疱疹病毒和梅毒螺旋体的分子检测的性能特征。

Performance characteristics of the SpeeDx PlexPCR VHS assay for the molecular detection of herpes simplex virus, varicella zoster virus, and Treponema pallidum in lesion swabs.

机构信息

West of Scotland Specialist Virology Centre, Glasgow Royal Infirmary, Glasgow, UK.

West of Scotland Specialist Virology Centre, Glasgow Royal Infirmary, Glasgow, UK.

出版信息

Diagn Microbiol Infect Dis. 2021 Feb;99(2):115221. doi: 10.1016/j.diagmicrobio.2020.115221. Epub 2020 Sep 21.

DOI:10.1016/j.diagmicrobio.2020.115221
PMID:33176262
Abstract

This study compares the performance of a commercial polymerase chain reaction (PCR) assay for detection of herpes simplex virus (HSV) 1 and 2, varicella zoster virus (VZV), and Treponema pallidum with laboratory-developed assays. A panel of 250 samples, previously tested using in-house assays, was tested on the PlexPCR® VHS assay. The panel consisted of 202 positive specimens [HSV-1 (n=51); HSV-2 (n=51); VZV (n=51); T. pallidum (n=49)] and 48 negative specimens. Genital samples had been previously tested for HSV-1/2 and T. pallidum and nongenital or unspecified samples for HSV-1/2 and VZV. The overall agreement between the PlexPCR® VHS and in-house assays was 97%. Negative agreement was ≥99%, and positive agreement for individual targets was 96% (47/49) for T. pallidum, 98% for HSV-1 and HSV-2 (50/51), and 100% (51/51) for VZV. Adoption of this assay would allow greater availability of molecular syphilis detection and enhance the diagnostic yield of samples collected from cutaneous/mucocutaneous lesions.

摘要

本研究比较了一种商用聚合酶链反应(PCR)检测试剂盒,用于检测单纯疱疹病毒(HSV)1 和 2、水痘带状疱疹病毒(VZV)和梅毒螺旋体,以及实验室开发的检测方法。一个由 250 个样本组成的小组,之前使用内部检测方法进行了测试,在 PlexPCR® VHS 检测试剂盒上进行了测试。该小组包括 202 个阳性样本[HSV-1(n=51);HSV-2(n=51);VZV(n=51);T. pallidum(n=49)]和 48 个阴性样本。生殖器样本之前已经过 HSV-1/2 和 T. pallidum 的检测,非生殖器或未指定样本则进行 HSV-1/2 和 VZV 的检测。PlexPCR® VHS 和内部检测方法之间的总体一致性为 97%。阴性一致性≥99%,对于个别目标的阳性一致性为梅毒螺旋体 96%(47/49),HSV-1 和 HSV-2 为 98%(50/51),VZV 为 100%(51/51)。采用这种检测方法将能够更广泛地提供分子梅毒检测,并提高从皮肤/粘膜病变采集的样本的诊断产量。

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