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评估新型 VERSANT CT/GC DNA 1.0 检测试剂盒在尿液标本中检测沙眼衣原体和淋病奈瑟菌的性能。

Evaluation of the new test VERSANT CT/GC DNA 1.0 assay for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens.

机构信息

Section of Microbiology, DESOS, University of Bologna, Bologna, Italy.

出版信息

J Clin Lab Anal. 2012 Feb;26(2):70-2. doi: 10.1002/jcla.21485.

DOI:10.1002/jcla.21485
PMID:22467321
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6807475/
Abstract

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are the two most common sexually transmitted bacterial infections in developed countries. The purpose of the present study was evaluating a new system for CT/GC detection in urine specimens. A total of 700 urine specimens were obtained from patients attending the STD Outpatients Clinic of St. Orsola University Hospital, Bologna, Italy. Samples were tested by VERSANT® CT/GC DNA 1.0 Assay (Siemens Healthcare Diagnostics Inc., Tarrytown, NY), a multiplex Real-Time PCR assay, for simultaneous CT/GC detection. Results obtained by VERSANT assay were compared with those obtained by culturing genital secretions of the same patients. Moreover, urine specimens testing positive in VERSANT assay were retested by in-house PCR assays, used as confirmatory tests. VERSANT® CT/GC DNA 1.0 Assay performed with 99.4% and 99.2% of specificity for GC and CT detection, respectively, whereas sensitivity was 100% both for CT and GC. Culture methods were 100% specific, but far less sensitive than VERSANT assay. VERSANT® CT/GC DNA 1.0 Assay demonstrated to be a highly sensitive and specific technique for CT/GC detection.

摘要

沙眼衣原体(CT)和淋病奈瑟菌(GC)是发达国家最常见的两种性传播细菌感染。本研究旨在评估一种新的尿液标本 CT/GC 检测系统。总共从意大利博洛尼亚圣奥尔索拉大学医院性传播疾病门诊患者中获得了 700 份尿液标本。通过 VERSANT® CT/GC DNA 1.0 检测试剂盒(Siemens Healthcare Diagnostics Inc.,Tarrytown,NY)对这些标本进行了检测,该试剂盒是一种用于同时检测 CT/GC 的多重实时 PCR 检测方法。将 VERSANT 检测方法获得的结果与同一患者的生殖道分泌物培养结果进行比较。此外,对 VERSANT 检测呈阳性的尿液标本进行了内部 PCR 检测,作为确认检测。对于 GC 和 CT 的检测,VERSANT® CT/GC DNA 1.0 检测试剂盒的特异性分别为 99.4%和 99.2%,而敏感性均为 100%。培养方法的特异性为 100%,但敏感性远低于 VERSANT 检测方法。VERSANT® CT/GC DNA 1.0 检测试剂盒是一种用于 CT/GC 检测的高度敏感和特异的技术。

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