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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。
Objective To investigate the value of recombinant Mycobacterium tuberculosis Rv1656 protein in the diagnosis of tuberculosis. Methods sputum smear, sputum culture and three commercially available Mycobacterium tuberculosis antibody kit as a control, the application of chemiluminescence enzyme immunoassay to detect 42 cases of tuberculosis patients and 54 cases of non-tuberculosis lung disease in patients with anti-Rv1656 antibody levels ; Rv1656 antibody detection working characteristic curve (ROC curve) was drawn to determine the critical value of its diagnosis of tuberculosis and evaluate the diagnostic efficacy. Results The urinary anti-Rv1656 antibody in tuberculosis patients was (39517.2 ± 11802.7pg / ml) and in non-tuberculosis respiratory patients (11416.3 ± 1145.4pg / ml), the difference was statistically significant (t = 3.002, P <0.01) The positive rate of anti-Rv1656 antibody in the urine of patients with bacillary negative TB was (47011.4 ± 1529.9pg / ml) and that of sputum positive TB was (15535.7 ± 1629.7pg / ml), the difference was statistically significant (t = 2.035, P <0.05). The diagnostic sensitivity of urine Rv1656 antibody to tuberculosis was 42.8%, and that of the Shanghai Aopu serum TB antibody kit was 71.4% (χ2 = 63.87, P <0.01). The diagnostic specificity of urinary Rv1656 antibody for tuberculosis was 83.3%, and that of the Shanghai Aopu serum TB antibody kit was 38.9%. The difference was statistically significant (χ2 = 76.15, P <0.01). Conclusion The recombinant protein of Mycobacterium tuberculosis Rv1656 is antigen-specific and can be used as one of the combinatorial antigens detected by urinary tuberculosis antibody.