【摘要】 目的 以rCFP10-ESAT6为抗原用ELISA法检测结核病患者血清中IgG及IgM结核抗体，评价其特异性诊断结核病的价值。方法 建立以rCFP10-ESAT6和PPD为抗原的ELISA法，并与市售ELISA试剂盒结果作比较。结果 以60份健康体检者OD490+2s为正常界限值。rCFP10-ESAT6检测血清IgG诊断结核病的正常界限值为0.204，其诊断结核病的特异性和敏感性分别为96.23%(102/106)、29.85%(20/67)；PPD检测血清IgG诊断结核病的正常界限值为0.625，其诊断结核病的特异性和敏感性分别为93.40%(99/106)、61.19%(41/67)；MAKER结核病诊断试剂盒诊断结核病的特异性和敏感性分别为77.36%(82/106)、49.25%(33/67)；以PPD和rCFP10-ESAT6为抗原检测血清IgM抗体，不能区分结核患者和非结核患者。结论 以rCFP10-ESAT6为抗原，用ELISA法检测结核IgG抗体诊断结核病患者的特异性高于以PPD为抗原的ELISA法和市售结核ELISA试剂盒，但其敏感性有待提高。

    【关键词】 结核分枝杆菌；重组CFP10-ESAT6融合蛋白；ELISA

    Study on application of recombinant CFP10-ESAT6 to detect antibody in sera by ELISA

    ZHOU Yong-bi，CHEN Quan.

    Department of Infectious Diseases， The First Affiliated Hospital， Chongqing University of Medical Sciences，Chongqing 400046，China

    【Abstract】 Objective To evaluate the specificity and sensitivity of ELISA based on rCFP10-ESAT6 fusion protein by detecting Mtb antibody in sera. Methods ELISA based on rCFP10-ESAT6 and PPD were established to detect Mtb antibody (IgG and IgM). Results The positive cutoff value was OD490 plus 2 standard deviation based on healthy individual. The positive cutoff value of rCFP10-ESAT6 and PPD was 0.204 and 0.625 respectively. The specificity and sensitivity of ELISA based on rCFP10-ESAT6 to diagnose the pulmonary tuberculosis by detecting IgG was 96.23%(102/106) and 29.85%(20/67) respectively ......