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目的对重组结核分枝杆菌11k Da蛋白(以下简称重组11k Da蛋白)皮肤试验与体外干扰素γ(interferonγ,IFNγ)检测方法进行比较。方法选取32名健康志愿者进行重组11k Da蛋白和TB-PPD的同体双臂皮肤试验,分别于不同前臂皮内注射0.1 ml重组11k Da蛋白(10μg/ml)和0.1 ml TB-PPD(50 IU/ml),注射后24、48、72 h测量志愿者皮肤反应(硬结和红晕)的两个直径(最大径和最大径的垂直径),并取其均值。于皮肤试验前采集32名志愿者的静脉血,分离外周血单个核细胞,采用T-SPOT.TB试剂盒进行检测。比较重组11k Da蛋白皮肤试验与体外IFNγ检测结果的一致性。结果以注射72 h后的硬结反应统计重组11k Da蛋白皮肤试验中阳性人数为8名,阳性率为25%,TB-PPD皮肤试验中阳性人数为24名,阳性率为75%,其中强阳性人数为8名;体外IFNγ检测(T-SPOT.TB)阳性人数为7名,阳性率为22%。重组11k Da蛋白皮肤试验结果和体外IFNγ检测结果一致性良好(Fleiss Kappa值=0.913),这两种检测方法的阳性率远低于TB-PPD皮肤试验(Fleiss Kappa值=0.266)。结论重组11k Da蛋白皮肤试验的检测结果与体外IFNγ检测结果基本一致,有潜力成为结核分枝杆菌潜伏感染者的新筛查方法。
Objective To compare the detection of recombinant Mycobacterium tuberculosis 11k Da protein (hereinafter referred to as recombinant 11k Da protein) with the in vitro interferon γ (IFNγ) assay. Methods Thirty-two healthy volunteers were used to carry out the arms-skin test of 11kDa protein and TB-PPD in vivo. 0.1ml recombinant 11kDa protein (10μg / ml) and 0.1ml TB-PPD / ml), two diameters (maximum diameter and maximum diameter vertical diameter) of volunteer skin reactions (induration and flushing) were measured at 24, 48 and 72 h after injection, and the mean value was taken. Venous blood from 32 volunteers was collected before the skin test. Peripheral blood mononuclear cells were isolated and tested using the T-SPOT.TB kit. Comparison of recombinant 11kDa protein skin test with in vitro IFNγ test results. Results According to the induration reaction at 72 h after injection, the positive number of recombinant 11 kDa protein skin test was 8, the positive rate was 25%. The positive number of TB-PPD skin test was 24, with a positive rate of 75% The number of T-SPOT.TB positive in vitro was 7, with a positive rate of 22%. The results of recombinant 11k Da protein skin test were in good agreement with the in vitro IFNγ test (Fleiss Kappa value = 0.913). The positive rates of these two tests were much lower than those of the TB-PPD skin test (Fleiss Kappa = 0.266). Conclusion The results of skin test of recombinant 11k Da protein are in good agreement with the results of IFNγ detection in vitro and have the potential to become a new screening method for latent infection of Mycobacterium tuberculosis.