实时荧光RNA恒温扩增技术在沙眼衣原体和淋球菌检测中的临床应用价值评估

Clinical application value evaluation of real-time RNA simultaneous amplification and testing in the detection of Chlamydia trachomatis and Neisseria gonorrhoeae

目的评估实时荧光RNA恒温扩增技术(SAT)在生殖道沙眼衣原体(CT)和淋球菌(NG)检测中的临床应用价值。方法对186例疑似生殖道沙眼衣原体感染或淋病患者尿道或宫颈拭子分别采用实时荧光定量PCR(CT-RT-PCR)和SAT检测CT(CT-SAT);采用分离培养与鉴定(NG培养法)以及SAT检测淋球菌(NG-SAT)。对于差异样本,采用常规PCR进行鉴定。配对卡方检验统计分析检测结果。结果SAT技术对CT、NG检测阳性率分别为8.1%、10.2%,略高于CT-RT-PCR(7.0%)和NG培养法(9.1%),但差异无统计学意义。配对卡方检验显示SAT法与传统方法检测结果一致性较好。以CT-RT-PCR为金标准,CT-SAT的特异度和敏感度分别为98.3%和92.3%;CT-RTPCR加常规PCR检测结果作为扩大金标准,CT-SAT的特异度和敏感度分别为100.0%和93.8%。以NG培养法为金标准,NG-SAT的特异度和敏感度分别为98.8%和100.0%;NG培养法加常规PCR检测结果作为扩大金标准,NG-SAT的特异度和敏感度均为100.0%。结论SAT技术与传统金标准方法的检测结果一致性较好,且有较高的特异度和敏感度,适于沙眼衣原体和淋球菌的临床实验室检测。

Objective To evaluate the clinical application of the real-time RNA simultaneous amplification and testing(SAT)method in the detection of Chlamydia trachomatis(CT)and Neisseria gonorrhoeae(NG).Methods Realtime PCR(RT-PCR)and SAT were used to detect Chlamydia trachomatis from urethral or cervical swabs of 186 suspected patients,while NG isolation and identification,as well as NG-SAT,were used to detect gonococcus from the same batch of samples.We used conventional PCR to verify inconsistent results.The paired chi-square test was employed to perform the statistical analysis.Results The positive rate of SAT detection of CT and NG were 8.1%and 10.2%,respectively.These figures were higher than those from the conventional assays(7.0%and 9.1%,respectively).However,there is no statistical significance.Paired chi-square test showed favorable consistency between SAT and conventional assays.Taking RT-PCR as the gold standard,the specificity and sensitivity of CT-SAT were 98.3%and 92.3%,respectively.The result was 100.0%and 93.8%,respectively using the extended gold standard.As for the NG test,the specificity and sensitivity of SAT were98.8%and 100.0%,respectively using the culture method as the gold standard.The results(specificity and sensitivity)were 100.0%using the extended gold standard.Conclusion SAT shows high consistency with the traditional reliable approaches and has high specificity and sensitivity.Therefore SAT is suitable for clinical laboratory testing of CT and NG.