Clinical utilization of multiple antibodies of <i>Mycobacterium tuberculosis</i> for serodiagnosis evaluation of tuberculosis: a retrospective observational cohort study
Creators: name: Bi, DeWu
name: Liang, ChaoJuan
name: Huang, XiaoXian
name: Pan, HuiDan
name: Qin, Yue
name: Shi, XiMing
name: Tang, YunHua
name: Wang, Ying
name: Zhao, MingMei
name: Lin, JianYan
name: Xie, ZhouHua
name: Wen, LeMin
name: Chen, ChaoYou
name: Tang, XiKe
name: Luo, XiaoCheng
name: Shao, HongHua
name: Luo, XiaoLu
Publisher: name: Taylor & Francis
Year: 2023
Subjects: subject: Medicine
subject: Microbiology
subject: FOS: Biological sciences
subject: Biotechnology
subject: Immunology
subject: FOS: Clinical medicine
subject: Biological Sciences not elsewhere classified
subject: Science Policy
subject: Hematology
subject: Infectious Diseases
subject: FOS: Health sciences
subject: Virology
subject: Computational Biology

description: We aimed to investigate clinical uncertainties by characterizing the accuracy and utility of commercially available antibodies of <i>Mycobacterium tuberculosis</i> in the diagnostic assessment of suspected tuberculosis in high-burden countries. We conducted a retrospective, descriptive, cohort study among participants aged ≥ 18 years with suspected tuberculosis in Nanning, Guangxi, and China. Participants were tested for <i>M. tuberculosis</i> infection using commercially available antibodies against <i>Mycobacterum tuberculosis</i>. 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. 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. Commercially available antibodies against to <i>Mycobacterium tuberculosis</i> 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. Existing <i>M. tuberculosis</i> antigens do achieve a limited sensitivity and negative predictive value to rule out a diagnosis of tuberculosis.<i>M. tuberculosis</i> antigens may help to rule in a diagnosis of active or latent tuberculosis in clinical setting among the high burden tuberculosis countries.This study is the largest retrospective, descriptive, cohort study to evaluate the clinical utilization of existing <i>M. tuberculosis</i> antigens integrating <i>M. tuberculosis</i> immunogens in patients with suspected active tuberculosis in high-burden country. Existing <i>M. tuberculosis</i> antigens do achieve a limited sensitivity and negative predictive value to rule out a diagnosis of tuberculosis. <i>M. tuberculosis</i> antigens may help to rule in a diagnosis of active or latent tuberculosis in clinical setting among the high burden tuberculosis countries. This study is the largest retrospective, descriptive, cohort study to evaluate the clinical utilization of existing <i>M. tuberculosis</i> antigens integrating <i>M. tuberculosis</i> immunogens in patients with suspected active tuberculosis in high-burden country. Existing antibodies against <i>M. tuberculosis</i> antigens exhibit limited sensitivity for ruling out TB.Multiple TB antibodies against <i>M. tuberculosis</i> antigens may aid in identifying cases of active or latent tuberculosis.The biggest cohort for investigating clinical applications of TB antibodies. Existing antibodies against <i>M. tuberculosis</i> antigens exhibit limited sensitivity for ruling out TB. Multiple TB antibodies against <i>M. tuberculosis</i> antigens may aid in identifying cases of active or latent tuberculosis. The biggest cohort for investigating clinical applications of TB antibodies.