Rv1656重组蛋白在结核病辅助诊断中的应用价值研究

目的研究结核分枝杆菌Rv1656重组蛋白在结核病辅助诊断中的应用价值。方法以痰涂片、痰培养及3个商品化的结核杆菌抗体试剂盒为对照,应用化学发光酶免疫分析法检测42例结核病患者和54例非结核肺部疾病患者尿液中抗Rv1656抗体水平;绘制抗Rv1656抗体检测工作特征曲线(ROC曲线),确定其诊断结核病的临界值,并评价其诊断效能。结果结核病组患者尿液抗Rv1656抗体为(39517.2±11802.7pg/ml),非结核呼吸病组为(11416.3±1145.4pg/ml),差异有统计学意义(t=3.002,P<0.01);痰菌阴性结核病患者尿液中抗Rv1656抗体为(47011.4±1529.9pg/ml),痰菌阳性结核患者为(15535.7±1629.7pg/ml),差异有统计学意义(t=2.035,P<0.05)。尿Rv1656抗体诊断结核的灵敏度为42.8%,上海奥普血清结核抗体试剂盒为71.4%,差异有统计学意义(χ2=63.87,P<0.01)。尿Rv1656抗体诊断结核的特异性为83.3%,上海奥普血清结核抗体试剂盒为38.9%,差异有统计学意义(χ2=76.15,P<0.01)。结论结核分枝杆菌Rv1656重组蛋白具有抗原特异性可作为尿液结核抗体检测的组合抗原之一。

Study on the value of using Rv1656 recombinant proteins to help diagnose tuberculosis

Objective To study the value of using Mycobacterium tuberculosis （TB） Rv1656 recombinant protein to help diagnose TB. Methods Sputum smears, sputum cultures, and three commercially available kits with M. tuberculosis antibodies served as controls. A chemiluminescent enzyme immunoassay was used to detect levels of antibodies against Rv1656 in urine from 42 patients with TB and 54 patients with some other respiratory illness. A receiver operating characteristic （ROC） curve was created for antibodies against Rv1656. The critical value for definitive diagnosis of TB was identified. Diagnostic performance was also evaluated. Results Levels of antibodies against Rv1656 in urine were （39517.2±11802.7） pg/ml for patients with TB and （11416. 3±1145.4） pg/ml for patients with a respiratory illness other than TB. The difference in antibody levels was statistically significant （t： 3. 002, P±0.01）. Levels of antibodies against Rv1656 in urine for （47011.4±1529.9） pg/ml for patients with sputum that was negative for TB and （15535.7± 1629） pg/ml. 7 for patients with sputum that was positive for TB. The difference in antibody levels was statistically significant （t=2. 035, P〈0.05）. Antibodies against Rv1656 in urine had a sensitivity of diagnosing TB of 42.8% while the Shanghai Aopu serum TB antibody kit had a sensitivity of diagnosing TB of 71.4 %. The difference in sensitivity was statistically significant （χ2- 63.87, P〈0.01）. Antibodies against Rv1656 in urine had a specificity of diagnosing TB of 83.3% while the Shanghai Apo serum TB antibody kit had a specificity of diagn6sing TB of 38. 9%. The difference in specificity was statistically significant （χ2=76.15, P〈0.01）. Conclusion Mycobacterium tuberculosis Rv1656 recom binant protein is a specific antigen that can be used as with other antigens to detect antibodies against TB in urine.