四种结核抗原用于结核病血清学诊断的初步评价

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。

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

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.