Van Dyck E, Ieven M, Pattyn S, Van Damme L, Laga M
STD/HIV Research and Intervention Unit, Department of Microbiology, Institute of Tropical Medicine, Nationalestraat 155, B-2000 Antwerp, Belgium.
J Clin Microbiol. 2001 May;39(5):1751-6. doi: 10.1128/JCM.39.5.1751-1756.2001.
The purpose of this study was to evaluate and compare three commercially available nucleic acid amplification tests (NAATs) for the detection of Neisseria gonorrhoeae and Chlamydia trachomatis. Roche PCR and Becton Dickinson strand displacement amplification (SDA) were performed on 733 endocervical swab specimens from commercial sex workers. Abbott ligase chain reaction (LCR) was performed on a subset of 396 samples. Endocervical specimens from all women were also tested by culture for N. gonorrhoeae and by Syva MicroTrak enzyme immunoassay (EIA) for C. trachomatis. A positive N. gonorrhoeae result was defined as a positive result by culture or by two NAATs, and a positive C. trachomatis result was defined as a positive result by two tests. According to these definitions, the sensitivities and specificities for the subsample of 396 specimens of N. gonorrhoeae culture, PCR, SDA, and LCR were 69.8, 95.2, 88.9, and 88.9% and 100, 99.4, 100, and 99.1%, respectively; the sensitivities and specificities of C. trachomatis EIA, PCR, SDA, and LCR were 42.0, 98.0, 94.0, and 90.0% and 100, 98.0, 100, and 98.6%, respectively. The performance characteristics of N. gonorrhoeae culture, PCR, and SDA and C. trachomatis EIA, PCR, and SDA for all 733 specimens were defined without inclusion of LCR results and by discrepant analysis after resolution of discordant N. gonorrhoeae PCR results and of discordant C. trachomatis EIA and PCR results by LCR testing. The sensitivities of N. gonorrhoeae culture, PCR, and SDA before and after LCR resolution were 67.8, 95.7, and 93.9% and 65, 95.8, and 90.0%, respectively. The sensitivities of C. trachomatis EIA, PCR, and SDA decreased from 39.4, 100, and 100% to 38.7, 98.7, and 94.7%, respectively. All three NAATs proved to be superior to N. gonorrhoeae culture and to C. trachomatis EIA. The accuracies of the different NAATs were quite similar. SDA was the only amplification assay with 100% specificity for detection of both N. gonorrhoeae and C. trachomatis in endocervical specimens.
本研究的目的是评估和比较三种市售核酸扩增检测(NAATs)方法,用于检测淋病奈瑟菌和沙眼衣原体。对733名商业性工作者的宫颈拭子标本进行了罗氏聚合酶链反应(PCR)和贝克顿·迪金森链置换扩增(SDA)检测。对396份样本的子集进行了雅培连接酶链反应(LCR)检测。所有女性的宫颈标本还通过淋病奈瑟菌培养和赛瓦MicroTrak酶免疫测定(EIA)检测沙眼衣原体。淋病奈瑟菌阳性结果定义为培养阳性或两种NAATs检测均为阳性,沙眼衣原体阳性结果定义为两种检测均为阳性。根据这些定义,396份淋病奈瑟菌培养、PCR、SDA和LCR标本子样本的敏感性和特异性分别为69.8%、95.2%、88.9%、88.9%和100%、99.4%、100%、99.1%;沙眼衣原体EIA、PCR、SDA和LCR的敏感性和特异性分别为42.0%、98.0%、94.0%、90.0%和100%、98.0%、100%、98.6%。在不纳入LCR结果且通过LCR检测解决淋病奈瑟菌PCR结果不一致以及沙眼衣原体EIA和PCR结果不一致后进行差异分析,确定了所有733份标本的淋病奈瑟菌培养、PCR和SDA以及沙眼衣原体EIA、PCR和SDA的性能特征。LCR解决前后淋病奈瑟菌培养、PCR和SDA的敏感性分别为67.8%、95.7%、93.9%和65%、95.8%、90.0%。沙眼衣原体EIA、PCR和SDA的敏感性分别从39.4%、100%、100%降至38.7%、98.7%、94.7%。所有三种NAATs均被证明优于淋病奈瑟菌培养和沙眼衣原体EIA。不同NAATs的准确性相当相似。SDA是唯一一种对宫颈标本中淋病奈瑟菌和沙眼衣原体检测特异性均为100%的扩增检测方法。