结核分枝杆菌蛋白抗原诊断试剂的临床价值研究

目的研究和评估基于结核分枝杆菌蛋白抗原(TB-SA)研制的结核诊断试剂盒在结核病诊断中的应用价值。方法运用胶体金法分别检测结核组、非结核其他呼吸系统疾病组、健康对照组血清TB-SA结核抗体。结果 TB-SA结核抗体检测结核的灵敏度为72.2%,特异度95.8%,检测结核病患者阳性率(72.2%)明显高于涂片法(44.9%)和培养法(37.1%),差异均有统计学意义(P0.05)。结论 TB-SA抗体检测具有较好的敏感性和特异性,对结核病诊断和鉴别诊断有较高的临床应用价值。

Clinical value of a diagnostic reagent for mycobacterium tuberculosis special antigen

Objective To research and evaluate the clinical value of a diagnostic reagent for tuberculosis (TB) antibodies based on mycobacterium tuberculosis special antigen (TB‐SA) .Methods Serum levels of TB‐SA of TB group ,non‐TB respiratory disease group and healthy control group were detected by immune colloidal gold technique .Results The sensitivity of TB‐SA for detection of TB was 72 .2% and the specificity was 95 .8% .The positive rate of TB‐SA antibodies (72 .2% ) was higher than sputum smear (44 .9% ) and culture (37 .1% ) ,the differences had statistical significance(P<0 .05) .Conclusion The TB‐SA antibody detection has high sensitivity and specificity ,which has good clinical application value for diagnosis and differential diagnosis of TB .