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[目的]评价两种免疫色谱法试剂盒[结核分枝杆菌复合群鉴定试剂盒、结核分枝杆菌抗原检测试剂盒(胶体金法)]对分枝杆菌诊断系统(BACTEC MGIT 960 System)阳性培养物快速鉴定结核分枝杆菌复合群(MTBC)的临床价值。[方法]对15株分枝杆菌标准菌株及418例BACTEC MGIT 960阳性培养物采用两种免疫色谱法试剂盒和传统生化法鉴定结核分枝杆菌复合群和非结核分枝杆菌。鉴定结果不一致的菌株,应用16S r RNA基因序列法进行检测。[结果]以传统生化法为金标准,胶体金法鉴定结核分枝杆菌复合群的灵敏度为98.4%(253/257),特异度为99.4%(160/161),阳性预期值为99.6%(253/254),阴性预期值为97.6%(160/164);MGIT TBc ID试剂盒鉴定结核分枝杆菌复合群的灵敏度为98.4%(253/257),特异度为100%(161/161),阳性预期值为100%(253/253),阴性预期值为97.6%(161/165)。与传统生化法比较,2种方法的一致性分别是Kappa值0.975、0.980,两种方法的一致性均较好。5株鉴定结果不一致的菌株应用16S r RNA基因序列法检测结果分别为4株MTBC,1株诺卡氏菌。[结论]胶体金法能快速鉴定结核分枝杆菌复合群,可用于BACTEC MGIT 960培养系统分枝杆菌培养阳性物的鉴定,适合在临床实验室开展。MGIT TBc ID试剂盒检测的准确性高,更适合应用在突发公共卫生检测。
[Objective] To evaluate the immunogenicity of Mycobacterium tuberculosis diagnostic system (BACTEC MGIT 960 System) by using two kinds of immunochromatographic reagents [Mycobacterium tuberculosis complex identification kit and Mycobacterium tuberculosis antigen test kit (colloidal gold assay)] Rapid identification of Mycobacterium tuberculosis complex (MTBC) clinical value. [Method] Fifteen Mycobacterium standard strains and 418 BACTEC MGIT 960 positive cultures were identified by Mycobacterium tuberculosis complex and Mycobacterium tuberculosis using two kinds of immunochromatographic reagent kits and traditional biochemical methods. Identification of inconsistent strains, the application of 16S r RNA gene sequence detection. [Results] The sensitivity of the Mycobacterium tuberculosis complex was 98.4% (253/257), the specificity was 99.4% (160/161) and the positive predictive value was 99.6% (based on the traditional biochemical method as the gold standard) 253/254). The negative predictive value was 97.6% (160/164). The sensitivity of MGT TBc ID kit was 98.4% (253/257) and the specificity was 100% (161/161) , The positive predictive value was 100% (253/253), and the negative predictive value was 97.6% (161/165). Compared with the traditional biochemical methods, the consistency of the two methods are Kappa values of 0.975,0.980, the consistency of the two methods are better. The results of 16S rRNA gene sequencing of 5 isolates with different identification results were 4 MTBC and 1 Nocardia respectively. [Conclusion] The colloidal gold method can rapidly identify the Mycobacterium tuberculosis complex, which can be used for the identification of positive mycobacteria culture products of BACTEC MGIT 960 culture system and is suitable for clinical laboratory. MGIT TBc ID test kit for high accuracy, more suitable for public health testing.