免疫色谱法从液体培养物中快速鉴定结核分枝杆菌复合群的效果评价

Evaluation of Immunochromatogaphic Assays for Rapid Identification of Mycobacterium tuberculosis Complex from Liquid Culture

[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 clinical application value of two immunochromatogaphic assay kits [Mycobacterium tuberculosis complex identification kit （MGIT TBc ID test） and Mycobacterium tuberculosis antigen assay kit （Capilia TB assay）] for rapid identification of Mycobacterium tuberculosis complex （MTBC） in Mycobacteria testing system （BACTEC MGIT 960 System） positive cultures. [ Methods ] Reference myeobaeterial strains （n=15） and BACTEC MGIT 960 System positive culture samples （n=418） were collected to apply two immunochromatogaphic assay kits and traditional biochemical method to identify MTBC and nontuberculous mycobacteria. Inconsistent identification results were confirmed by 16S rRNA gene sequencing. [ Results ] The traditional biochemical method was used as the gold standard. The sensitivity, specificity, positive predictive value, and negative predictive value of Capilia TB assay for MTBC detection were 98.4% （253/257）, 99.4% （160/161）, 99.6% （253/254）, and 97.6% （160/164）, respectively; those of MGIT TBc ID test were 98.4% （253/257）, 100% （161/161）, 100% （253/253）, and 97.6% （161/165）, respectively. Compared with the traditional biochemical method, the Kappa values of Capilia TB assay and MGIT TBc ID test were 0.975 and 0.980 respectively, indicating good consistency. The results of 16S rRNA gene sequencing for inconsistent strains were 4 strains of MTBC and 1 strain of Nocardia. [ Conclusion ] The Capilia TB assay represents a rapid, simple MT identification test that could be used to BACTEC MGIT 960 System positive cultures in clinical laboratories. The MGIT TBc ID test is more accurate and could be used in public health emergencies.