Tanaka M, Nakayama H, Yoshida H, Takahashi K, Nagafuji T, Hagiwara T, Kumazawa J
Department of Urology, Faculty of Medicine, Kyushu University, Japan.
Sex Transm Infect. 1998 Dec;74(6):435-8. doi: 10.1136/sti.74.6.435.
To evaluate the performance of a new improved enzyme immunoassay (EIA) kit for the detection of Chlamydia trachomatis in vaginal swab and endocervical swab specimens from female commercial sex workers, in comparison with a conventional EIA test and a polymerase chain reaction (PCR) assay.
A high risk group of 163 female commercial sex workers who visited a sexually transmitted disease (STD) clinic in order to undergo screening for major STDs, including chlamydial infection, were enrolled. A total of four swab specimens, including two vaginal and two endocervical specimens, were collected from each woman by a clinician. To identify C trachomatis, a new improved EIA kit (IDEIA PCE), a conventional EIA kit (IDEIA), and PCR assay (Amplicor) were used. Discrepancies in the results were resolved using supplementary PCR assay. A female patient was considered to be infected with C trachomatis if the IDEIA PCE test and PCR test for both sample sites (endocervical and vaginal) gave positive results. Following resolution of these discrepancies, relative sensitivity and specificity, confidence intervals, and predictive values for each type of specimen by each assay were calculated.
Of the 163 women tested, 35 (21.5%) were shown to be infected with C trachomatis. The relative sensitivities in vaginal swab specimens were 88.8%, 68.6%, and 91.4% using IDEIA PCE, IDEIA, and PCR, respectively. The relative specificities in vaginal swab specimens were 99.2%, 99.2%, and 100%, respectively. The relative sensitivities in endocervical swab specimens were 85.7%, 77.1%, and 91.4% with IDEIA PCE, IDEIA, and PCR, respectively. The relative specificities in endocervical swab specimens were all 100%.
The results obtained in this study suggest that the sensitivity and specificity of IDEIA PCE test on vaginal swab and endocervical swab specimens were similar to those of PCR assay on the two types of specimen. It is concluded that IDEIA PCE test on vaginal swab specimens is an acceptable, sensitive, and less invasive approach for the detection of C trachomatis in commercial sex workers with a high prevalence of C trachomatis infection.
与传统酶免疫测定(EIA)试验及聚合酶链反应(PCR)检测法相比,评估一种新的改良酶免疫测定试剂盒用于检测女性商业性工作者阴道拭子和宫颈管拭子标本中沙眼衣原体的性能。
招募了163名前往性传播疾病(STD)诊所进行包括衣原体感染在内的主要性传播疾病筛查的高危女性商业性工作者。临床医生从每位女性身上共采集4份拭子标本,包括2份阴道标本和2份宫颈管标本。为鉴定沙眼衣原体,使用了一种新的改良EIA试剂盒(IDEIA PCE)、一种传统EIA试剂盒(IDEIA)和PCR检测法(Amplicor)。结果差异通过补充PCR检测法解决。如果IDEIA PCE检测和两个样本部位(宫颈管和阴道)的PCR检测结果均为阳性,则该女性患者被视为感染沙眼衣原体。在解决这些差异后,计算每种检测方法对每种类型标本的相对敏感性、特异性、置信区间和预测值。
在接受检测的163名女性中,有35名(21.5%)被证明感染沙眼衣原体。使用IDEIA PCE、IDEIA和PCR检测阴道拭子标本时,相对敏感性分别为88.8%、68.6%和91.4%。阴道拭子标本的相对特异性分别为99.2%、99.2%和100%。使用IDEIA PCE、IDEIA和PCR检测宫颈管拭子标本时,相对敏感性分别为85.7%、77.1%和91.4%。宫颈管拭子标本的相对特异性均为100%。
本研究结果表明,IDEIA PCE检测法对阴道拭子和宫颈管拭子标本的敏感性和特异性与PCR检测法对这两种类型标本的敏感性和特异性相似。得出结论,对于沙眼衣原体感染率较高的商业性工作者,对阴道拭子标本进行IDEIA PCE检测是一种可接受、敏感且侵入性较小的检测沙眼衣原体的方法。