沙眼衣原体荧光PCR试剂盒的研制及临床考核

Development of Chlamydia Trachomatis Fluorescence PCR Diagnostic Kit and Its Clinical Trial

【目的】用荧光PCR(fluorescencePCR ,F PCR)方法研制沙眼衣原体 (chlamydiaTrachomatis,CT)DNA检测试剂盒 ,通过临床验证考核其性能 ,并与其它方法比较。【方法】设计合成了CTF PCR诊断试剂盒。检测了 5 16份临床分泌物标本 ,以McCoy细胞培养法和Abbott公司的LCx试剂盒为对照。【结果】阳性率 2 1 1% ,灵敏性 98 2 % ,特异性 99 8%。【结论】F PCR显著优于培养法 ,与LCx相当。F PCR试剂盒可以检测CT的真实感染情况 ,对于临床诊断和疗效考察有一定的指导意义。

Use a new F PCR method to develop a chlamydia trachomatis (CT) diagnostic kit, and test it through clinical trial and compare it with other diagnostic methods. A clinical diagnostic kit for CT was developed with F PCR. 516 clinical secretion samples were tested with this kit, McCoy cell culture method and LCx DNA diagnostic kit from Abbott were used as the contrast methods. The positive rate is 21 1%, sensitivity 98 2% and specificity 99 8%. [Conclusion] F PCR is obviously suprior to cell culture method, and has the same sensitivity as LCx. F PCR can be used to monitor DNA of CT in secretion, it is useful to clinical diagnose and therapy effects monitoring.