全自动荧光酶免疫分析仪检测泌尿生殖道衣原体的评价  

Evaluation of the VIDAS chlamydia test detect Chlamydia trachomatis in samples from urogenital tract

作　　者：倪安平[1] 朱晓春[1] 王宝玺[1] 何海英[2] 秦俭[3] 

机构地区：[1]中国医学科学院中国协和医科大学北京协和医院检验科,100730 [2]中国医学科学院中国协和医科大学北京协和医院皮肤科,100730 [3]北京大学北京第一医院皮肤科

出　　处：《中华检验医学杂志》2001年第3期190-192,共3页Chinese Journal of Laboratory Medicine

摘　　要：目的　评价生物梅里埃公司的全自动荧光酶免疫分析系统 (VIDAS)检测衣原体 (CHL)的敏感性和特异性。方法　应用VIDAS检测CHL与细胞培养比较 ,不符者使用直接荧光抗体技术验证 ;同时使用CHL菌株D和E血清型 ,应用上述两种方法 ,进行敏感性的比较。结果　 16 3份性病科门诊男女患者尿道和宫颈拭子标本中 ,细胞培养阳性者 33份 (2 0 .2 % ) ,以扩大的金标准计算 ,其敏感性为 80 .5 % ,特异性是 10 0 %。VIDAS检测出CHL 44份 (2 7.0 % )阳性标本 ,敏感性和特异性分别为95 .3%和 97.6 %。CHL菌株D和E血清型敏感性试验中 ,培养阳性的最高滴度分别为 1∶10 2 40 0和 1∶5 12 0 0 ,VIDAS检测CHL的阳性的最高滴度均为 1∶6 5 5 36 0 0。结论　与扩大的金标准比较 ,VIDAS检测CHL具有良好的敏感性和特异性。该仪器操作简便 ,检测时间仅为 1h。此外 ,还可用于尿液标本中的沙眼衣原体检测 。Objectives To evaluate bioMerieux VIDAS(Vitek Immune Diagnositc Assay System) Chlamydia test (CHL) and to determine its performance(sensitivity and specificity) by comparing with cell culture. Methods C. trachomatis in urogenital samples was detected by both cell culture and VIDAS CHL. The different results were confirmed by direct fluorescent antibody assay (DFA). The sensitivity to C.trachomatis serotype D and E stocks was alsode tected with VIDAS CHL and cell culture. Results C.trachomatis was found in 33 (20.2%) of 163 urogenital samples by cell culture in coutrast to in 44(27.0%) by VIDA CHL. As the expanded gold standard was defined as either cell culture positive or cell culture negative and both CHL and DFA positive, the sensitivity was 80.5% and 95.3% and the specifiaty were 100% and 97.6% in cell culture and VIDAS CHL, respectively. In the sensitivity test, C. trachomatis serotype D was tested positive at the highest dilution of one to 102 400 dilution and serotype E was at one in 51 200 by cell culture. However, both serotype D and E were tested positive at the highest dilution of one to 6 553 600 by VIDAS CHL. Conclusions Comparing with the expanded gold standard, VIDAS CHL is sensitive and specific for C.trachomatis in urogenital specimens, with simple and short running hours (1 h). First catch urine (FCU), which avoids the painful male swab collectionin male patients, could also be used as specimen in VIDAS CHL test.

关 键 词：衣原体属 细胞培养 直接荧光抗体技术 泌尿生殖道感染 尿液 

分 类 号：R446.5[医药卫生—诊断学]