沙眼衣原体培养、LCR与荧光PCR在检测泌尿生殖道沙眼衣原体的意义

Comparative study of cell culture, fluorescent PCR and LCR in detection of C. trachomatis

为了比较细胞培养、连接酶链反应(LCR)和荧光PCR技术在检测性传播疾病门诊患者标本沙眼衣原体的意义。分别在国内5家临床医院性传播疾病门诊收集到673份尿道/宫颈拭子标本,进行沙眼衣原体培养和荧光PCR检测,检测结果不相符合的标本采用LCR复检,比较分析PCR与培养、LCR以及综合结果的相符性。结果合格病例616例,培养和荧光PCR的检测阳性率分别为6.33%和27.1%,与培养相比,荧光PCR法的敏感性为100%。LCR复核标本200份,与之相比,荧光PCR的敏感性为98.6%,特异性89.5%,YI指数为0.881。综合分析证明荧光PCR检测沙眼衣原体的敏感性为98.78%,特异性为98.67%,YI指数0.9745。结合临床表现发现,男性患者出现尿道炎症体征意义大于症状,而在女性患者症状或体征均不特异。结果表明国产荧光PCR技术检测尿道/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。

The diagnositic performances of fluorescent PCR(FPCR) in detection of C. trachomatis were determined by using endocervical and urethral swabs and cell culture and a ligase chain reaction (LCR) were compared as references. Endocervical or urethral swab specimens were collected from 673 patients attended STD clinics in Beijing, Shanghai, Nanjing and Tianjin. All specimens were detected by cell culture and FPCR while LCR were performed only with specimens which the culture and PCR gave discrepant reports.The results showed that 616 patients had complete sets of specimens and medical records. Thirty nine (6.33%) cases were culture positive and FPCR revealed a prevalence of 27.1%. In comparing with cell culture, the sensitivity of FPCR was 100%. In 200 specimens detected by LCR, FPCR showed excellent consistency(YI index: 0.881 ), the sensitivity and specificity of FPCR were 98.6% and 89.5% respectively (YI index: 0.881). When we compared the results with an overall true positive standard, which was defined as culture positive or LCR positive plus at least another PCR positive, the specificity and sensitivity of PCR were 98.78% and 98.67%, respectively. Clinically, physical signs other than symptoms were more significant in male patients while it was not so apparent in females. In conclusions, domestic developed FPCR technique is a highly sensitive and specific method for detection of C. trachomatis, however, quality control still remains importance in its clinical application.