用于结核病血清学诊断评估的多种抗体的临床应用：一项回顾性观察性队列研究。

Clinical utilization of multiple antibodies of for serodiagnosis evaluation of tuberculosis: a retrospective observational cohort study.

机构信息

Department of Clinical Laboratory, The Fourth People's Hospital of Nanning, Nanning, China.

Key Laboratory of Infectious Diseases, The Fourth People's Hospital of Nanning, Nanning, China.

出版信息

Ann Med. 2023 Dec;55(1):2238186. doi: 10.1080/07853890.2023.2238186.

DOI:10.1080/07853890.2023.2238186

PMID:37477876

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10364559/

Abstract

OBJECTIVES

We aimed to investigate clinical uncertainties by characterizing the accuracy and utility of commercially available antibodies of in the diagnostic assessment of suspected tuberculosis in high-burden countries.

METHODS

We conducted a retrospective, descriptive, cohort study among participants aged ≥ 18 years with suspected tuberculosis in Nanning, Guangxi, and China. Participants were tested for infection using commercially available antibodies against . Specificity, sensitivity, negative and positive predictive values, and negative and positive likelihood ratios of the tests were determined. Sputum specimens and bronchoalveolar lavage fluid were sent for mycobacterial culture, Xpert MTB/RIF assay, and cell-free M. tuberculosis DNA or RNA assay. Blood samples were used for IGRAs, T-cell counts (CD3 + CD4+ and CD3 + CD8+), and antibodies to tuberculosis test.

RESULTS

Of the 1857 participants enrolled in this study, 1772 were included in the analyses, among which, 1311 were diagnosed with active tuberculosis. The specificity of antibody against 16kD for active tuberculosis was 92.7% (95% confidence interval [CI]: 89.3-95.4) with a positive likelihood ratio for active tuberculosis cases of 3.1 (95% CI: 2.1-4.7), which was higher than that of antibody to Rv1636 (90.5% [95% CI: 86.6-93.5]), antibody to 38kD (89.5% [95% CI: 85.5-92.7]), antibody against CFP-10 (82.6% [95% CI: 77.9-86.7]), and antibody against LAM (79.3% [95% CI: 74.3-83.7]). Sensitivity ranged from 15.8% (95% CI: 13.9-17.9) for antibody against Rv1636 to 32.9% (95% CI: 30.4-35.6) for antibody to LAM.

CONCLUSIONS

Commercially available antibodies against to do not have sufficient sensitivity for the diagnostic evaluation of active tuberculosis. However, antibody against Rv1636 and 16kD may have sufficiently high specificities, high positive likelihood ratios, and correspondingly high positive predictive values to facilitate the rule-in of active tuberculosis.

摘要

目的

通过描述性队列研究，评估现有商业化抗体检测在高负担国家疑似结核病患者中的诊断效能，以明确诊断中的不确定性。

方法

本研究为回顾性研究，纳入在广西南宁市的疑似结核病患者。采用商业化的抗抗体检测试剂盒检测患者的感染情况，分析其对诊断活动性结核病的敏感度、特异度、阳性预测值、阴性预测值、阳性似然比和阴性似然比。同时收集患者的痰标本和支气管肺泡灌洗液进行分枝杆菌培养、Xpert MTB/RIF 检测、游离结核分枝杆菌 DNA 或 RNA 检测，血液标本进行 IGRA、T 细胞计数（CD3+CD4+和 CD3+CD8+）和结核抗体检测。

结果

本研究共纳入 1857 名患者，其中 1772 名纳入分析，1311 名患者确诊为活动性结核病。抗 16kD 抗体对活动性结核病的特异度为 92.7%（95%CI：89.3-95.4），其对活动性结核病的阳性似然比为 3.1（95%CI：2.1-4.7），高于抗 Rv1636 抗体（90.5%[95%CI：86.6-93.5]）、抗 38kD 抗体（89.5%[95%CI：85.5-92.7]）、抗 CFP-10 抗体（82.6%[95%CI：77.9-86.7]）和抗 LAM 抗体（79.3%[95%CI：74.3-83.7]）。抗 Rv1636 抗体的敏感度最低，为 15.8%（95%CI：13.9-17.9），抗 LAM 抗体的敏感度最高，为 32.9%（95%CI：30.4-35.6）。