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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
Diagnostic Microbiology and Infectious Disease ( IF 2.1 ) Pub Date : 2020-09-21 , DOI: 10.1016/j.diagmicrobio.2020.115221
Emily J Goldstein 1 , Lauren Cochrane 1 , Simon M Bone 2 , Rory N Gunson 1
Affiliation  

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.



中文翻译:

SpeeDx PlexPCR VHS分析在病变拭子中用于分子检测单纯疱疹病毒,水痘带状疱疹病毒和苍白螺旋体的性能特点

这项研究通过实验室开发的检测方法,比较了用于检测单纯疱疹病毒(HSV)1和2,水痘带状疱疹病毒(VZV)和苍白螺旋体的商业聚合酶链反应(PCR)检测的性能。的250个样本,先前使用内部测定中测试,所述的面板对所测试的Plex的PCR®VHS测定。该小组由202例阳性标本组成[HSV-1(n = 51);HSV-2(n = 51);VZV(n = 51); T. pallidumn = 49)]和48个阴性样本。生殖器样品先前已经测试了HSV-1/2和苍白密螺旋体和非生殖器或未指定样品HSV-1/2和VZV。之间的总体协议PCR®VHS和内部测定为97%。阴性一致性≥99%,单个目标的阳性一致性对于苍白螺旋体为96%(47/49),HSV-1和HSV-2为50%(51/51)和100%(51/51)用于VZV。采用该测定法将允许分子梅毒检测的更大可用性,并提高从皮肤/粘膜皮肤病变中收集的样品的诊断产率。

更新日期:2020-11-09
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