Accuracy of multitarget indirect enzyme-linked immunoassay assay for detection of tuberculosis antibody.
Accuracy of multitarget indirect enzyme-linked immunoassay assay for detection of tuberculosis antibody.
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DOI：
10.21037/atm-21-5598
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发表时间：
2021-12
影响因子：
--
通讯作者：
Liu Z
中科院分区：
文献类型：
--
作者：
Hu Y;Liu M;Hu H;Yang H;Qin L;Hu Z;Zhu C;Liu Z
结核病的诊断仍然很困难。开发用于诊断结核病的快速和敏感的实验室工具是一个优先事项。本研究旨在建立间接酶联免疫分析法（ELISA）检测TB抗体的方法，并通过多中心临床评价探讨其对肺结核（PTB）患者的诊断价值。通过分子克隆和噬菌体肽文库筛选获得特异性抗原、融合抗原和特异性抗体肽。建立了一种使用多种靶材料的间接ELISA检测方法。此外，该方法在6家机构进行了验证，研究对象包括临床确诊的结核病患者、非结核病肺部疾病患者和健康对照者。以16 kD抗原、11488 （CFP10-MPT48-TB8.4）融合抗原、TB18和pl2作为TB抗体的靶抗原，建立间接ELISA检测方法。本多中心研究结果显示，该检测方法的灵敏度为48.25%，特异度为92.20% (95% CI: 90.7 ~ 93.5%)，受试者工作特征曲线下面积（AUC）为0.724 (95% CI: 0.707 ~ 0.741)，临界值为0.119。meta分析显示，合并ROC为0.736 (95% CI: 0.692-0.779), I2=83.73%。痰液阳性PTB组（培养或涂片阳性）的敏感性为58.75% (95% CI: 52.96 ~ 65.00%)；痰液阴性组（培养或涂片阴性）的敏感性分别为37.38% (95% CI: 32.71 ~ 42.52%)；痰液阳性组的敏感性显著高于痰液阴性组（OR =1.57, 95% CI: 1.29 ~ 1.92， P<0.001）。基于特异性TB抗原、融合抗原和抗体肽的多靶点间接ELISA检测对PTB的诊断有一定价值，可作为一种辅助快速诊断工具，提高痰阴性TB的敏感性。
Diagnosis of tuberculosis (TB) is still difficult. The development of rapid and sensitive laboratory tools for the diagnosis of tuberculosis is a priority. This study aimed to develop an indirect enzyme-linked immunoassay (ELISA) assay for detection of TB antibody and explore its diagnostic value in patients with pulmonary tuberculosis (PTB) via a multi-center clinical evaluation. The specific antigen, fusion antigen, and specific antibody peptide were obtained using molecular cloning and phage peptide library screening. An indirect ELISA assay was developed using multiple target materials. Further, the assay was validated in six institutions with clinically confirmed TB patients, non-TB patients with pulmonary disease, and healthy controls as research subjects. An indirect ELISA assay was developed with 16 kD antigen, 11,488 (CFP10-MPT48-TB8.4) fusion antigen, and TB18 and pl2 as target antigens against TB antibody. The results of this multicenter study showed that the sensitivity, specificity, and the area under the receiver operating characteristic curve (AUC) of the assay were 48.25% [95% confidence interval (CI): 45.5–51.1%], 92.20% (95% CI: 90.7–93.5%) and 0.724 (95% CI: 0.707–0.741), respectively, and the cut-off value was 0.119. According to the meta-analysis, the combined ROC was 0.736 (95% CI: 0.692–0.779), I2=83.73%. The sensitivity of the sputum-positive PTB group (culture or smear positive) was 58.75% (95% CI: 52.96–65.00%); the sensitivity in sputum-negative group (culture or smear negative) was 37.38% (95% CI: 32.71–42.52%), respectively; the sensitivity of the sputum-positive group was significantly higher than that of sputum-negative group (OR =1.57, 95% CI: 1.29–1.92, P<0.001). Multitarget indirect ELISA assay based on specific-TB antigen, fusion antigen, and antibody peptide is of value for the diagnosis of PTB and can be used as an auxiliary rapid diagnostic tool to improve the sensitivity of sputum-negative TB.
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