全自动荧光酶免疫分析仪检测沙眼衣原体临床应用评价

Detection of Chlamydia trachomatis in Samples from Urogenital Tract by VIDAS Chlamydia Test: An Evaluation

目的评价法国生物梅里埃公司全自动荧光免疫分析仪系统(VIDAS),检测衣原体(CHL)的敏感性和特异性,为临床提供选择方法的依据。方法应用VIDAS检测CHL与临床确诊比较,不符合者使用直接荧光抗体技术验证。结果463份泌尿科或妇科患者的尿道及宫颈拭子标本中,临床确诊病例83例(17.9%),以扩大金标准计算,敏感率为92.2%,特异性为100%;VIDAS检测出93例阳性,敏感率为100%,特异性为96.8%。结论VIDAS检测CHL具有良好的敏感率和特异性,具有操作简便、报告时间短的优点,适宜常规实验室使用。

OBJECTIVE To evaluate Bio-Merieux VIDAS (VITEK Immune Diagnostic Assay System) Chlamydia test (CHL) and to determine its sensitivity and specificity by comparing with clinical diagnosis. METHODS Chlamydia trachomatis in urogenital sample was detected by VIDAS CHL. If the results of VIDAS were different with clinical diagnosis, the results would be confirmed by direct fluorescent-antibody assay (DFA). RESULTS CHL infection was defined in 83 (17.9%) of 463 urogenital samples by clinical diagnosis, and in 93 (20.1%) (by VIDAS) CHL, the sensitivity and specificity were 92.2% and 100%, and 100% and 96.8%, respectively. CONCLUSIONS Comparing with the expanded gold standard, VIDAS CHL sensitive and specific for C. trachomatis in urogenital specimens, with simplicity and short running hours (1 h). VIDAS is a good tool for detect (C. trachomatis) in routine laboratory.