目的与细胞培养和连接酶链反应 (LCR)比较考察 6种国产聚合酶链反应 (PCR)试剂盒在检测性传播疾病门诊患者标本沙眼衣原体的诊断价值。方法在北京、上海、南京、天津 5家临床医院性病门诊收集到 673份尿道 /宫颈拭子标本，分别进行沙眼衣原体培养和 PCR检测，对结果不相符合的标本采用 LCR复检，将各种 PCR检测结果分别与培养、 LCR以及综合结果进行比较分析。结果合格病例 616例，培养法检测阳性率 6.3％， PCR检测阳性率分别为 23.5％～ 28.7％。与培养结果比较，各种 PCR检测的敏感性均在 90％以上，其中 PCR1、 PCR2和 PCR5均达到 100％。 LCR复核标本 200份，与之相比， PCR检测的敏感性为 83.9％～ 98.6％，特异性 66.7％～ 94.7％， YI指数 0.523～ 0.881。其中 PCR2结果符合性最好，其它依次为 PCR4、 PCR1、 PCR5、 PCR3及 PCR6。综合分析证明国产 PCR检测沙眼衣原体的敏感性均在 85％以上，特异性均在 95％以上。 YI指数由高到低分别为 PCR2、 PCR1、 PCR3、 PCR5、 PCR4、 PCR6。结论国产 PCR检测尿道 /宫颈拭子沙眼衣原体具有较高的敏感性与特异性，可以用于临床检验，实验室质控与监督是本方法得以正确应用的关键。%Objective To evaluate the diagnostic value of six home made PCR kits for the detection of Chlamydia trachomatis in patients with sexually transmitted diseases, cell culture and LCR were used as references. Methods Endocervical or urethral swab specimens were collected from 673 patients attending STD clinics in Beijing, Shanghai, Nanjing and Tianjin. C. trachomatis culture and PCR were performed with specimens from all patients while LCR was performed only with specimens which the culture and PCR gave discrepant results. Results Among 616 eligible patients thirty－ nine (6.3％ ) cases were culture positive, and PCRs revealed positive rates from 23.5％ to 28.7％ . In comparison with cell culture, the sensitivity of PCRs were 90％ or higher. In 200 cases which the culture and PCR gave discrepant results, LCR and PCR showed excellent consistency (YI index: 0.523～ 0.881 ), the sensitivity and specificity of PCRs ranged from 83.9％ ～ 98.6％ and 66.7％ ～ 94.7％ respectively, while PCR2 showed the highest YI index (0.881). With an expanded gold standard for discrepant results, we found that the specificity and sensitivity of PCRs were higher than 95％ and 85％ , respectively. Conclusions Domestic produced PCR kits for Chlamydia trachomatis detection are highly sensitive and specific, however, the quality control of laboratory still remains important in the clinical application.
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