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.
出处
《实用预防医学》
CAS
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)