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目的探讨国产TB-IGRA试剂盒在痰涂片阴性肺结核诊断中的应用价值。方法用北京万泰生物药业股份有限公司生产的TB-IGRA试剂盒,分别检测229例痰涂片阴性和33例痰涂片阳性肺结核病患者、50例其他肺部疾病患者和50例健康对照者结核感染情况,并与英国Oxford Immunotec公司生产的T-SPOT-TB试剂盒比较检测的灵敏度、特异度、准确度及阴性似然比和阳性似然比。结果 TB-IGRA检测痰涂片阴性和阳性肺结核患者的阳性检出率分别为90.0%和93.9%,两者之间差异无统计学意义(χ2值为0.53,P>0.05)。TB-IGRA和T-SPOT-TB检测结核的灵敏度分别为90.5%和89.7%,特异度分别为86.0%和82.0%,2种试剂盒的灵敏度和特异度差异无统计学意义(χ2值分别为0.1、0.6,P>0.05)。TB-IGRA方法的准确度、阳性和阴性预测值、阳性似然比均高于T-SPOT-TB,阴性似然比低于T-SPOT-TB。结论 TB-IGRA检测痰涂片阴性肺结核具有快速和较高的灵敏度和特异度,值得临床推广应用。
Objective To investigate the value of domestic TB-IGRA kit in the diagnosis of sputum smear-negative pulmonary tuberculosis. Methods Totally 229 sputum smear-negative and 33 sputum-smear-positive pulmonary tuberculosis patients were tested with TB-IGRA kit produced by Beijing WANTTAI PHARMACEUTICAL CO., LTD., 50 patients with other pulmonary diseases and 50 healthy controls Of tuberculosis infection and compared the sensitivity, specificity, accuracy, negative likelihood ratio and positive likelihood ratio of the T-SPOT-TB kit manufactured by Oxford Immunotec in England. Results The positive rates of TB-IGRA in sputum smear negative and positive tuberculosis patients were 90.0% and 93.9%, respectively, with no significant difference (χ2 = 0.53, P> 0.05). The sensitivity of TB-IGRA and T-SPOT-TB for detection of tuberculosis was 90.5% and 89.7% respectively, and the specificity was 86.0% and 82.0% respectively. The sensitivity and specificity of the two kits were not significantly different (χ2 = 0.1, 0.6, P> 0.05). The accuracy, positive predictive value and negative predictive value of TB-IGRA method were all higher than that of T-SPOT-TB, and the negative likelihood ratio was lower than that of T-SPOT-TB. Conclusion The TB-IGRA test for sputum smear-negative pulmonary tuberculosis has rapid and high sensitivity and specificity, which is worthy of clinical application.