摘要
目的评价T淋巴细胞干扰素释放试验(T-SPOT.TB)快速诊断结核病的临床应用价值,并尝试确定新TSPOT.TB的阳性临界值,来降低T-SPOT.TB检测方法对非结核感染的误诊率。方法选择结核分枝杆菌感染的患者31例,非结核感染疾病病例96例,分别以早期分泌的抗原靶体-6KD,即抗原A(early secreted antigenic target 6,ESAT-6)和培养滤过蛋白-10KD,即B抗原(culture filltrate protein 10,CFP-10)作为刺激原,培养16~20 h,应用T-SPOT.TB检测特异性T淋巴细胞释放的干扰素-γ,并对敏感度和特异度进行分析,找出T-SPOT.TB检测的阳性临界值。结果以厂家提供阳性临界值为6 SFU的诊断标准在31例结核分枝杆菌感染患者中,28例结核感染患者T-SPOT.TB阳性,敏感度为90.3%,非结核感染疾病组96例,88例T-SPOT.TB阴性,特异度为91.7%,将结核感染病例组做受试者工作特征曲线(ROC曲线)表明,当T-SPOT.TB阳性临界值为15 SFU时,敏感度为86.9%,特异度为93.1%。结论运用TSPOT.TB检测试剂作为结核感染的检查,具有较好的敏感度和特异度,但若选择产家提供的检测阳性临界值为6 SFU,在本院容易引起疑似患者的误诊,因此根据试验结果得出T-SPOT.TB检测阳性临界值应定为15 SFU,敏感度为86.9%、特异度为93.1%,这样可以尽量减少疑似患者的误诊。
Objective To evaluate the clinical application value of T cell interferon-gamma release assay （T-SPOT. TB） in the rapid diagnosis of tuberculosis and to try to identify its new cut-off value so as to decline its misdiagnosis rate. Methods Thirty-one patients with Mycobacterium tuberculosis infection and 96 patients with non-TB diseases were enrolled. Antigen A （early secreted antigenic target-6,ESAT-6） and antigen B （culture filtrate protein-10,CFP-10） were used for the stimuli, and then cultured for 16-20 hours. T-SPOT.TB assay was used to detect interferon gamma （IFN-γ） released by the specific T cells, and its sensitivity and specificity were analyzed. The critical value of T-SPOT.TB assay was identified. Results When the cut-off value of 6 SFU recomended by the manufacturer of the reagent was considered as the diagnostic standard, , 28 out of 31 patients with Mycobacterium tuberculosis infection were T-SPOT.TB positive, with the sensitivity of 90.3%, and 88 of 96 patients with non-TB diseases were T-SPOT.TB negative, with the specificity of 91.7%. The receiver operating characteristic curve （ROC curve） based on the tuberculosis infection group showed that when the cut-off value of T-SPOT.TB was defined as 15 SFU, the sensitivity and specificity were 86.9% and 93.1% respectively. Conclusions T-SPOT.TB assay in the detection of Mycobacterium tuberculosis infection has a high sensitivity and specificity. But defining the cut-off value as 6 SFU suggested by the manufacturer of the reagent can easily induce misdiagnosis of suspected patients in the Second Xiangya Hospital of Central South University. Having the cut-off value as 15 SFU, the sensitivity and specificity of T-SPOT.TB assay are 86.9% and 93.1% respectively, which can decline the misdiagnosis of suspected patients.
出处
《实用预防医学》
CAS
2017年第3期272-274,共3页
Practical Preventive Medicine
