重组结核分支杆菌38kD和16kD蛋白用于结核病血清学诊断的价值

Evaluation of the recombinant 38kD and 16kD antigen of MycobacteriumTuberculosis for serodiagnostic test

目的 探讨国产重组结核分支杆菌蛋白 38kD(rTPA38)和 16kD(rTPA16)用于结核病的诊断价值。方法 以rTPA38和rTPA16为抗原 ,PPD为对照 ,用ELISA法检测血清中特异性抗结核抗体。结果 2 4 6例肺结核病组 ,rTPA38、rTPA16和PPD检测的灵敏度分别为 66.3%、63.0 %和 72 .3%。健康献血组、非结核呼吸疾病组和卡介苗接种阳转组血清同时用rTPA38、rTPA16和PPD检测 ,rTPA38特异性分别为 97.6%、96.8%、86.0 %。rTPA16特异性分别为 94 .7%、93.1%、75 .0 %。PPD特异性为93.4 %、85 .7%、67.9%。统计分析显示 ,rTPA38蛋白和PPD检测非结核呼吸疾病组 ,其阳性率有显著性差异 (P <0 .0 5 )。两者检测卡介苗接种阳转组阳性率和血清抗体滴度有显著性差异 (P <0 .0 5 )。rTPA38和rTPA16同时检测 10 8例肺结核病组血清可提高 11.1%的阳性率。结论 rTPA38蛋白抗原有较好的灵敏度和较高特异性 ,是ELISA的可靠抗原 ,与rTPA16联用可提高灵敏度 ,对结核病血清学诊断有较高参考价值。

Objective The recombinant 38kD and 16kD protein of Mycobacterium tuberculosis (rTPA38 and rTPA16) as serological diagnostic reagents were evaluated.Methods The purified rTPA38 and rTPA16 were used to detect sera antibodies using enzyme linked immunosorbent assay (ELISA),and using the PPD as control.Results In detecting the sera of 246 pulmonary tuberculosis patients,the sensitivity of rTPA38,rTPA16 and PPD was 66.3%,63.0% and 72.3% respectively.The specificity of rTPA38,rTPA16 and PPD in detecting of other groups:healthy controls,non tuberculosis respiratory patients,BCG vaccinated healthy controls,was 97.6%, 96.8%, 86.0%;94.7%,93.1%,75.0% and 93.4%,85.7%,67.9% respectively.In detecting the sera of non tuberculosis respiratory patients and BCG vaccinated healthy controls,rTPA38 had much more positive reactions than that of PPD.To the sera of pulmonary tuberculosis patients,using combination of rTPA38 and rTPA16 as detecting antigens can improve the positive rate by 11.1%.Conclusion rTPA38,which can provide a satisfactory sensitivity and specificity,may become effective antigen in ELISA.A combination of rTPA38 and rTPA16 can improve the sensitivity.