Diagnostic value of chemiluminescence for urinary lipoarabinomannan antigen assay in active tuberculosis: insights from a retrospective study

Front Cell Infect Microbiol. 2023 Dec 8:13:1291974. doi: 10.3389/fcimb.2023.1291974. eCollection 2023.

Abstract

Purpose: This study aimed to assess the efficacy of chemiluminescence-based urinary lipoarabinomannan (LAM) antigen assay as a diagnostic tool for identifying active tuberculosis.

Methods: A retrospective study was conducted on 166 Tuberculosis (TB), 22 Non-Tuberculous Mycobacteria (NTM), 69 Non-TB cases, and 73 healthy controls from Zhangjiagang First Peoples Hospital between July 2022 and November 2022. Clinical and laboratory data were collected, including urine samples for LAM antigen detection, sputum samples and pleural effusion for GeneXpert, TB-DNA, and culture.

Results: TB group exhibited a higher LAM positivity rate (P < 0.001). CD4 count and diabetes as independent factors influencing the diagnostic accuracy of LAM. The LAM assay showed a sensitivity of 50.6% and a specificity of 95.65%. Notably, LAM's sensitivity was superior to TB-DNA (50.60% vs. 38.16%, P < 0.05). LAM's PTB detection rate was 51.7%, superior to TB-DNA (P = 0.047). Moreover, in EPTB cases, the LAM detection rate was 42.11%, surpassing Gene Xpert (P = 0.042), as well as exceeding the detection rates of TB-DNA and sputum culture.

Conclusion: LAM antigen detection using chemiluminescence has demonstrated outstanding clinical diagnostic value for active TB, especially in the diagnosis of extrapulmonary TB. The convenience of sample collection in this diagnostic approach allows for widespread application in the clinical diagnosis of active tuberculosis, particularly in cases of EPTB and sputum-negative patients.

Keywords: active tuberculosis; chemiluminescence method; diagnostic value; retrospective study; urine LAM antigen detection.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • DNA
  • HIV Infections*
  • Humans
  • Lipopolysaccharides
  • Luminescence
  • Mycobacterium tuberculosis* / genetics
  • Retrospective Studies
  • Sensitivity and Specificity
  • Sputum / microbiology
  • Tuberculosis* / diagnosis

Substances

  • lipoarabinomannan
  • Lipopolysaccharides
  • DNA

Grants and funding

The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This work was supported in part by grants from the Respiratory Infectious Diseases Clinical Medical Center of Suzhou, China (Szlcyxzx202108); Youth Science and Technology Project of Suzhou, China (KJXW2022046) and Zhangjiagang Medical and Health Technology Innovation Guidance Project, China (ZKYL2233).