I-SPOT.TB与T-SPOT.TB试剂盒在结核病诊断中的应用价值及其诊断一致性分析  

Application value and diagnostic consistency of I-SPOT.TB and T-SPOT.TB in the diagnosis of tuberculosis

作　　者：樊茹 刘红伟 邱万 李晓非 Fan Ru;Liu Hongwei;Qiu Wan;Li Xiaofei(School of Public Health,Dali University,Dali Yunan 671003,China;Yunnan Provincial Center for Infectious Diseases Clinical Medicine,The Third People's Hospital of Kunming,Kunming Yunan 650041,China)

机构地区：[1]大理大学公共卫生学院,云南大理671003 [2]昆明市第三人民医院云南省传染性疾病临床医学中心,云南昆明650041

出　　处：《中华临床实验室管理电子杂志》2022年第4期210-214,共5页Chinese Journal of Clinical Laboratory Management(Electronic Edition）

基　　金：云南省科技厅科技计划项目(202001BA070001-136)。

摘　　要：目的比较探讨国产I-SPOT.TB和进口T-SPOT.TB试剂在诊断结核病方面的临床价值。方法选取2020年9-12月来自昆明市第三人民医院的结核病患者237例(菌阳肺结核121例、菌阴肺结核98例、肺外结核18例)、非结核病患者60例和健康体检者42例作为研究对象,均进行I-SPOT.TB和T-SPOT.TB试剂检测,比较两种方法诊断结核病的效能。结果国产I-SPOT.TB与进口T-SPOT.TB试剂在结核病组、非结核病患者组、健康体检组、菌阳肺结核组、菌阴肺结核组、肺外结核组的阳性检出率比较,差异均无统计学意义(均P>0.05)。两种方法检测结果的总体符合率为91.15%,阳性符合率为91.30%,阴性符合率为90.82%,Kappa值为0.802。两种方法在诊断结核病敏感度及特异度比较差异均无统计学意义(均P>0.05)。I-SPOT.TB的ROC曲线下面积为0.845,T-SPOT.TB为0.859,均超过诊断有效标准0.5,两种方法诊断准确性均较好。结论结核感染T细胞酶联免疫斑点试验在结核病诊断中应用价值较高;国产与进口试剂具有较好的诊断一致性,今后可在我国临床中推广应用。Objective To compare the clinical value of domestic and imported enzyme-linked immunospot method reagents in the diagnosis of tuberculosis.Methods 237 tuberculosis patients(121 cases of bacterium-positive tuberculosis,98 cases of bacterium-negative tuberculosis and 18 cases of extrapulmonary tuberculosis),60 non-tuberculosis patients and 42 healthy donor from September to December 2020 in the Third People's Hospital of Kunming were selected and detected by I-SPOT.TB and T-SPOT.TB reagents.The efficacy of the two methods in the diagnosis of tuberculosis was compared.Results There was no significant difference in the positive detection rate between the domestic reagent and the imported T-SPOT.TB reagent in the tuberculosis group,the non-tuberculosis patient group,the healthy group,the bacteria-positive tuberculosis group,the bacteria-negative tuberculosis group,and the extrapulmonary tuberculosis group(P>0.05).The overall coincidence rate of the two methods was 91.15%,the positive coincidence rate was 91.30%,the negative coincidence rate was 90.82%and the kappa value was 0.802.There was no significant difference in the sensitivity and specificity of the two methods in the diagnose of TB(P>0.05).The area under the ROC curve of I-SPOT.TB and T-SPOT.TB were 0.845 and 0.859 respectively,which exceeded the diagnostic effective standard of 0.5.The diagnostic accuracy of both methods was good.Conclusions The application value of enzyme-linked immunospot test on T cells in tuberculosis diagnosis is high.Domestic and imported reagents have good diagnostic consistency,which can be applied in clinical practice in China in the future.

关 键 词：酶联免疫斑点试验 Γ-干扰素释放试验 结核病诊断 

分 类 号：R529.2[医药卫生—内科学] R446.6[医药卫生—临床医学]