四种结核抗原用于结核病血清学诊断的初步评价  

Preliminary evaluation of four antigens from Mycobacterium tuberculosis for serodiagnosis of tuberculosis

作　　者：林楠[1] 吴小翠[2] 赵平[4] 余琴[4] 庞慧[5] 万康林[1,2,3] 

机构地区：[1]传染病预防控制国家重点实验室,中国疾病预防控制中心传染病预防控制所,北京102206 [2]温州医科大学检验医学院,生命科学学院 [3]感染性疾病诊治协同创新中心 [4]北京市朝阳区疾病预防控制中心结核病防治所检验科 [5]长治医学院

出　　处：《实用预防医学》2014年第6期655-657,731,共4页Practical Preventive Medicine

基　　金：国家"艾滋病和病毒性肝炎等重大传染病防治科技重大专项"课题(2013ZX10003006-002-001)

摘　　要：目的对MPT63、Ag85A、RV2031c和融合蛋白CFP10-ESAT6四种结核分枝杆菌抗原进行诊断效能评价,优选出最佳的抗原组合,分析其应用价值。方法基于酶联免疫吸附试验,分别用MPT63、Ag85A、RV2031c和融合蛋白CFP10-ESAT6四种重组结核抗原,对199份血清（含94份结核病患者血清和105份健康者血清）进行检测。结合受试者工作特征曲线法计算不同抗原的最佳临界值（cut-off value）并以此确立各抗原组合的灵敏度、特异度、阳性预测值、阴性预测值和诊断效率,对它们的诊断效能和应用价值进行综合评价。结果 11种组合中Rv2031c与CFP10-ESAT6的组合诊断效能最好,灵敏度为63.8%,特异度为82.9%,阳性预测值为76.9%,阴性预测值为71.9%,诊断效率为73.9%。其余组合的灵敏度的范围30.9%～66%,特异度范围76.2%～90.5%。结论 Rv2031c和CFP10-ESAT6组合后的诊断效能最佳,有一定的临床应用价值。Objective To assess the performance of four recombination Mycobacterium tuberculosis protein antigens （MPT63, Ag85A, RV2031c and fusion protein CFP10 - ESAT6） in the serological diagnosis of tuberculosis, to select the optimal combina- tion of the antigens and to analyze their application values. Methods Based on enzyme- linked immunosorbent assay （ELISA）, 199 serum samples （94 from TB patients and 105 from healthy individuals） were tested by means of the four recombi- nation antigens respectively. Sensitivity, specificity, positive predictive value, negative predictive value and diagnostic efficiency were calculated after getting the cut- off value with the results of ELISA and receiver operating characteristic （RC）C） curve anal- ysis. Comprehensive diagnosis performance and application values of these antigens and different combinations were evaluated. Results Among the eleven kinds of combinations, the combination of Rv2031c and CFP10 - ESAT6 had the best diagnostic ef- ficiency, and its sensitivky, specificity, positive predictive value, negative predictive value and diagnostic efficiency were 63.8 %, 82.9%, 76.9%, 71.9% and 73.9%, respectively. The sensitivity and specificity of the other combinations ranged from 30.9 % to 66 % and from 76.2 % to 90.5 %, respectively. Conclusions The combination of antigens Rv203 lc and CFP10 - ESAT6 has very good performance in TB diagnosis and possesses a certain application value in clinical practice.

关 键 词：结合分枝杆菌 抗原组合 酶联免疫吸附试验 受试者工作特征曲线 

分 类 号：R521[医药卫生—内科学]