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作 者:王宝玺[1] 朱学骏[2] 倪安平[1] 叶顺章[3] 乐嘉豫 郑和义[1] 刘全忠 王千秋[3] 汤全贵 秦俭[2]
机构地区:[1]中国医学科学院北京协和医院,北京100730 [2]北京大学第一医院 [3]中国医学科学院中国协和医科大学皮肤病研究所 [4]上海市性病防治所 [5]天津医科大学总医院
出 处:《Chinese Journal of Sexually Transmitted Infections》2004年第1期15-19,63,共6页中华性传播感染杂志(英文版)
摘 要:Objective: To determine the diagnostic performancesof six Chinese PCR kits for detection of Chlamydiatrachomatis in patients with sexually transmitteddiseases using cell culture and LCR as references.Methods: Endocervical or urethral swab specimenswere collected from 673 patients attending STDclinics in Beijing, Shanghai, Nanjing and Tianjin. C.trachomatis culture and PCR were performed onspecimens from all patients while LCR detection wasperformed only on specimens with discordant cultureand PCR results.Results: Of the 616 patients, 6.3% (39) wereculture-positive while 23.5% to 28.7% were positiveby PCR testing. Compared to cell culture, the sensi-tivity of all six PCR methods was 90% or higher. In200 cases with discrepant reports, LCR and PCRshowed excellent consistency (YI index: 0.523-0.881 ), the sensitivity and specificity of PCR methodswere 83.9%- 98.6% and 66.7%- 94.7% respectively,while PCR2 showed the highest YI index (0.881). Withthe reference standard defined as culture positive orLCR positive plus at least one PCR positive fordiscrepant results, we found that the specificity andsensitivity of all six Chinese PCR kits were higherthan 95% and 85%, respectively.Conclusions: Domestically-produced PCR kits forChlamydia trachomatis detection are highly sensi-tive and specific, however, quality control remainsimportant in their clinical application.目的与细胞培养和LCR比较考察6 种国产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 家临床医院性传播疾病门诊收集到 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连接酶链反应(LCR)复检,比较分析检测结果。结果合格病例616 例,36 份培养法检测阳性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。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(YI指数0.881)。综合分析发现国产PCR技术检测沙眼衣原体的敏感性均在85%以上,特异性均在95%以上。结论国产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。
关 键 词:chlamydia trachomatis PCR DIAGNOSIS
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