实时荧光核酸恒温扩增技术检测无创样本沙眼衣原体的性能

Performance of real-time fluorescent nucleic acid constant temperature amplification technology for the detection of Chlamydia trachomatis in noninvasive samples

目的评估实时荧光核酸恒温扩增技术(SAT)检测无创样本沙眼衣原体的性能。方法以罗氏Cobas®4800CT/NG作为参照试剂,收集广西壮族自治区皮肤病研究所性病门诊就诊的男性患者尿液样本(248份)及女性患者阴道拭子样本(224份),评估SAT法检测沙眼衣原体的临床性能。结果最终有470份样本纳入统计。罗氏PCR检出阳性60例(12.8%),男性阳性数33例,女性27例;SAT检出沙眼衣原体阳性41例(8.7%),男性阳性数19例,女性22例。SAT试剂应用男性尿液检测的灵敏度为57.58%,特异性为99.06%;女性阴道拭子检测的灵敏度为81.48%,特异性100.00%。结论SAT试剂可以应用于无创样本,但是其应用尿液检测沙眼衣原体上还需要对尿液的核酸提取方法进一步的优化,提高其检测的灵敏性。

Objective To evaluate the performance of real-time fluorescent nucleic acid constant temperature amplification technology(SAT)detecting Chlamydia trachomatis in noninvasive samples.Methods The noninvasive specimens including urine samples of men(n=248)and vaginal swab samples of women(n=224)were collected from the outpatients in sexually transmitted disease(STD)clinic of Institute of Dermatology,Guangxi Zhuang Autonomous Region.The diagnostic value of SAT in Chlamydia trachomatis was evaluated in parallel with real-time PCR method Roche Cobas®4800CT/NG.Results There were 470 samples collected.Among these samples,60(12.8%)samples were positive for Chlamydia trachomatis by Roche assay including 33 male and 27 female samples;41(8.7%)samples were positive by SAT including 19 male and 22 female samples.The sensitivity and specificity for SAT were 57.58%and 99.06%in urine samples,and were 81.48%and 100.00%in vaginal swabs.Conclusions The SAT reagent can be applied in noninvasive specimens to detect Chlamydia trachomatis.Further optimization of the nucleic acid extraction method for urine samples is needed to improve its sensitivity.