Performance of ultra-sensitive electrochemiluminescence LAM assay for diagnosing tuberculosis in HIV-negative individuals: a multicentre, prospective diagnostic study - Takeaways - MDSpire

Performance of ultra-sensitive electrochemiluminescence LAM assay for diagnosing tuberculosis in HIV-negative individuals: a multicentre, prospective diagnostic study

  • By

  • Yuanyuan Shang

  • Jiachang Zhang

  • Wenli Cao

  • Mingui Lin

  • Yilin Wang

  • Lili Wang

  • Leping Zhong

  • Xiaohui Wang

  • Wenjing Hou

  • Wei Xu

  • Guiping Wu

  • Junfeng Wu

  • Yu Pang

  • Xinting Yang

  • June 22, 2026

  • 0 min

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  • 1

    Tuberculosis diagnosis primarily relies on sputum-based methods, which face challenges like prolonged turnaround times and low sensitivity.

  • 2

    Non-sputum-based diagnostic technologies, such as urine LAM antigen detection, offer promising alternatives for TB diagnosis.

  • 3

    The Alere Determine TB LAM Ag assay has limited sensitivity, while the Fujifilm SILVAMP TB LAM assay is validated only for HIV-positive patients.

  • 4

    A novel urine LAM assay developed by Guangzhou Leide Biosciences Co. enhances detection sensitivity for TB in HIV-negative individuals.

  • 5

    A prospective multicenter study was conducted to evaluate the diagnostic accuracy of the AIMLAM assay in HIV-negative adults with suspected pulmonary TB.

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