干扰素体外释放酶联免疫法在结核病诊断中的临床应用

Clinical application of T-cell based IFN-γ release assay in rapid diagnosis of tuberculosis

目的探讨干扰素体外释放酶联免疫法(IFN-γrelease assay,IGRA)在结核病诊断中的应用价值。方法采用北京万泰生产的γ-干扰素检测试剂盒分别检测493例结核病患者(包括391例肺结核和102例肺外结核)、108例其他肺部疾病患者和150例健康对照者结核感染情况,并与结核抗体试验(TB-AB)、痰菌培养及痰涂片比较检测的灵敏度和特异性。结果 TB-IGRA检测结核病患者的灵敏度为90.1%(444/493),肺结核和肺外结核的阳性检出率无显著性差异(P>0.05),TB-IGRA检测结核患者阳性检出率明显高于TB-AB试验、痰培养法和痰涂片法(P<0.01)。TB-IGRA方法的特异性为87.6%,与TB-AB方法特异性无显著性差异(P>0.05)。结论 TB-IGRA检测肺内结核、肺外结核具有快速和较高的灵敏度和特异性,值得临床推广应用。

Objective To evaluate the clinical application value of T- cell based IFN- γ release assay（ IGRA） in the rapid diagnosis of tuberculosis. Methods The serum specimens from 493 tuberculosis patients（ including 391 pulmonary TB cases and 102 extrapulmonary TB cases）,108 patients with other respiratory diseases and 150 healthy persons were collected to detect the tuberculosis infection status by TB- IGRA kit. Then the sensitivity and specificity of TB- IGRA were compared with those of tuberculosis antibody（TB- AB） method,sputum bacterial culture and sputum smear. Results The sensitivity of TB-IGRA was 90. 1%,and there was no significant difference between the positive detection rates of pulmonary tuberculosis and extrapulmonary tuberculosis（P〉0. 05）. The positive detection rate of TB- IGRA was higher than that of TB- AB,sputum culture and sputum smear（P〈0. 01）. The specificity of TB- IGRA was 87. 6%,and the specificity of TB- IGRA and TB- AB had no significant differences（P〉0. 05）. Conclusion TB- IGRA showed high sensitivity and specificity in rapid diagnosis of pulmonary TB and extrapulmonary TB,worthy of promotion in clinical practice.