Mukenge-Tshibaka L, Alary M, Bernier F, van Dyck E, Lowndes C M, Guédou A, Anagonou S, Joly J R
Epidemiology Research Group, Hôpital du Saint-Sacrement du CHA and Université Laval, Québec, Canada.
J Clin Microbiol. 2000 Nov;38(11):4076-9. doi: 10.1128/JCM.38.11.4076-4079.2000.
The objective of this study was to evaluate the diagnostic performance of the Roche multiplex AMPLICOR Chlamydia trachomatis/Neisseria gonorrhoeae PCR test for the detection of Neisseria gonorrhoeae infection in female urine specimens and wet and dry endocervical swabs. Endocervical swabs and urine specimens were collected from 342 female sex workers from Cotonou, Benin, and were tested using the AMPLICOR C. trachomatis/N. gonorrhoeae test (Roche Diagnostic Systems, Inc., Branchburg, N.J.) with internal control detection. Endocervical swabs were also cultured on Thayer-Martin medium. A series of alternate standards that included a combination of all the tests but not the test being evaluated was used to assess the performance of the test with each type of specimen. The sensitivity, specificity, and positive and negative predictive values for the urine were 53.8, 98.9, 93.5, and 87.5%, respectively. Corresponding figures for the wet swab were 91.5, 100, 100, and 97.4%, respectively. Those for the dry swab were 96.3, 96.2, 88.5, and 98.8%, respectively. Based on this study, the AMPLICOR PCR assay showed a low sensitivity for detection of N. gonorrhoeae infection in urine specimens, whereas the test was found to be highly sensitive and specific with endocervical specimens.
本研究的目的是评估罗氏多重AMPLICOR沙眼衣原体/淋病奈瑟菌聚合酶链反应（PCR）检测法对女性尿液标本以及宫颈湿拭子和干拭子中淋病奈瑟菌感染的诊断性能。从贝宁科托努的342名女性性工作者中采集宫颈拭子和尿液标本，并使用带有内控检测的AMPLICOR沙眼衣原体/淋病奈瑟菌检测法（罗氏诊断系统公司，新泽西州布兰奇堡）进行检测。宫颈拭子也接种在Thayer-Martin培养基上培养。使用一系列替代标准（包括除被评估检测法外的所有检测法的组合）来评估该检测法对每种类型标本的性能。尿液检测的敏感性、特异性、阳性预测值和阴性预测值分别为53.8%、98.9%、93.5%和87.5%。宫颈湿拭子的相应数值分别为91.5%、100%、100%和97.4%。宫颈干拭子的相应数值分别为96.3%、96.2%、88.5%和98.8%。基于本研究，AMPLICOR PCR检测法对尿液标本中淋病奈瑟菌感染的检测敏感性较低，而该检测法对宫颈标本具有高度敏感性和特异性。
