Performance of ultra-sensitive electrochemiluminescence LAM assay for diagnosing tuberculosis in HIV-negative individuals: a multicentre, prospective diagnostic study
4 affiliations
- 1Beijing Key Laboratory for Key Technologies in Tuberculosis Prevention and Control, Department of Bacteriology and Immunology, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, 101149 Beijing China
- 2The Second Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing, 101149 China
- 3Beijing Geriatric Hospital, Beijing, 100095 China
- 4Beijing Tsinghua Changing Hospital, Tsinghua University, Beijing, 102200 China
Abstract
Purpose: Optimization of urine lipoarabinomannan (LAM) detection platforms holds significant potential for improving early tuberculosis (TB) diagnosis. Currently, accurate urine LAM assays are notably lacking for HIV-negative populations. To address this gap, we evaluated the diagnostic accuracy of an Ultra-sensitive electrochemiluminescence LAM assay (AIMLAM) in HIV-negative individuals with suspected pulmonary TB in Beijing, China.
Methods: In this prospective multicentre study, we enrolled adult (≥ 18 years), presumptive TB patients in Beijing, China. All participants provided sputum samples for smear microscopy, Xpert MTB/RIF assay, and mycobacterial culture, as well as urine samples for AIMLAM testing. Diagnostic performance was evaluated against both microbiological reference standard (MRS) and a composite reference standard (CRS).
Results: We collected and stored urine samples from 692 HIV-negative adult presumptive TB patients. Of these, 315 were microbiologically confirmed TB cases, 177 had possible TB, and 200 were considered unlikely to have TB. When evaluated against the MRS, the AIMLAM assay demonstrated a sensitivity of 61.6% (95% CI: 56.1–66.8) and specificity of 83.0% (95% CI: 78.9–86.5). Using the CRS, the AIMLAM assay showed sensitivity 51.6% (95% CI: 47.3–55.9) but specificity 98.0% (95% CI: 94.9–99.4).
Conclusions: The Ultra-sensitive electrochemiluminescence LAM assay demonstrated favorable diagnostic accuracy, potentially offering rapid tuberculosis diagnosis for HIV-negative individuals with pulmonary TB.
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BibTeX
@article{shang2026performance,
title = {{Performance of ultra-sensitive electrochemiluminescence LAM assay for diagnosing tuberculosis in HIV-negative individuals: a multicentre, prospective diagnostic study}},
author = {Yuanyuan Shang and Jiachang Zhang and Wenli Cao and Mingui Lin and Yilin Wang and Lili Wang and Leping Zhong and Xiaohui Wang and Wenjing Hou and Wei Xu and Guiping Wu and Junfeng Wu and Yu Pang and Xinting Yang},
journal = {Infection},
year = {2026},
month = jun,
doi = {10.1007/s15010-026-02861-4},
url = {https://doi.org/10.1007/s15010-026-02861-4},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - Performance of ultra-sensitive electrochemiluminescence LAM assay for diagnosing tuberculosis in HIV-negative individuals: a multicentre, prospective diagnostic study
AU - Yuanyuan Shang
AU - Jiachang Zhang
AU - Wenli Cao
AU - Mingui Lin
AU - Yilin Wang
AU - Lili Wang
AU - Leping Zhong
AU - Xiaohui Wang
AU - Wenjing Hou
AU - Wei Xu
AU - Guiping Wu
AU - Junfeng Wu
AU - Yu Pang
AU - Xinting Yang
PY - 2026
DA - 2026/06/22
JO - Infection
DO - 10.1007/s15010-026-02861-4
UR - https://doi.org/10.1007/s15010-026-02861-4
AB - Purpose: Optimization of urine lipoarabinomannan (LAM) detection platforms holds significant potential for improving early tuberculosis (TB) diagnosis. Currently, accurate urine LAM assays are notably lacking for HIV-negative populations. To address this gap, we evaluated the diagnostic accuracy of an Ultra-sensitive electrochemiluminescence LAM assay (AIMLAM) in HIV-negative individuals with suspected pulmonary TB in Beijing, China. Methods: In this prospective multicentre study, we enrolled adult (≥ 18 years), presumptive TB patients in Beijing, China. All participants provided sputum samples for smear microscopy, Xpert MTB/RIF assay, and mycobacterial culture, as well as urine samples for AIMLAM testing. Diagnostic performance was evaluated against both microbiological reference standard (MRS) and a composite reference standard (CRS). Results: We collected and stored urine samples from 692 HIV-negative adult presumptive TB patients. Of these, 315 were microbiologically confirmed TB cases, 177 had possible TB, and 200 were considered unlikely to have TB. When evaluated against the MRS, the AIMLAM assay demonstrated a sensitivity of 61.6% (95% CI: 56.1–66.8) and specificity of 83.0% (95% CI: 78.9–86.5). Using the CRS, the AIMLAM assay showed sensitivity 51.6% (95% CI: 47.3–55.9) but specificity 98.0% (95% CI: 94.9–99.4). Conclusions: The Ultra-sensitive electrochemiluminescence LAM assay demonstrated favorable diagnostic accuracy, potentially offering rapid tuberculosis diagnosis for HIV-negative individuals with pulmonary TB.
SN - 0300-8126
SN - 1439-0973
ER -