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Clinical Report: Efficacy of an ultra-sensitive electrochemiluminescence LAM assay

Overview

This multicenter study evaluates the diagnostic accuracy of an ultra-sensitive electrochemiluminescence LAM assay for tuberculosis in HIV-negative patients.

Background

Tuberculosis (TB) poses a significant global health challenge, with timely diagnosis being crucial for effective treatment and transmission control. Traditional sputum-based diagnostic methods have limitations, including low sensitivity and operational complexity, particularly in HIV-negative populations. The development of non-sputum-based diagnostic technologies, such as urine LAM assays, offers a promising alternative for TB diagnosis.

Data Highlights

The study found that the AIMLAM assay demonstrated a sensitivity of 80% and a specificity of 95% in diagnosing TB among HIV-negative patients. In comparison, the existing urine LAM assays showed a sensitivity range of 40-60%, highlighting the superior performance of the AIMLAM assay.

Key Findings

• The novel AIMLAM assay shows enhanced sensitivity and specificity for detecting TB in HIV-negative patients.

• Current urine LAM assays, including AlereLAM, have suboptimal sensitivity (40-60%).

• The Fujifilm SILVAMP TB LAM assay has a sensitivity of approximately 67%, but is validated only for HIV-positive patients.

• Approximately 50% of active pulmonary TB patients do not exhibit typical symptoms, complicating diagnosis.

• Non-sputum-based diagnostics are particularly valuable for patients who cannot produce adequate sputum samples.

Clinical Implications

The AIMLAM assay may provide a diagnostic option for TB in HIV-negative patients.

Conclusion

The study evaluates the AIMLAM assay's ability to improve TB diagnosis in HIV-negative individuals.

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3. Infection, Evaluating the Diagnostic Precision of Interferon-Gamma Release Assays in HIV Patients with Potential Tuberculosis Infection: A Meta-Analysis, 2022

4. Open Forum Infectious Diseases, Evaluation of the VISITECT CD4 Advanced Disease Test's Accuracy and Acceptability Relative to the PIMA CD4 Test in Point-of-Care Settings Within the Advanced HIV Disease Care Framework: A Mixed-Methods Investigation, 2022

5. WHO consolidated guidelines on tuberculosis: module 3: diagnosis, 2025

6. Performance of ultra-sensitive urine lipoarabinomannan assay for diagnosing tuberculosis in HIV-negative individuals: a multicentre, prospective diagnostic study, 2026

7. Antigen heterogeneity in the development and clinical validation of a multiplexed urine test for tuberculosis, Communications Medicine, 2026

8. WHO consolidated guidelines on tuberculosis: module 3: diagnosis

9. Performance of ultra-sensitive urine lipoarabinomannan assay for diagnosing tuberculosis in HIV-negative individuals: a multicentre, prospective diagnostic study | Sciety

10. Antigen heterogeneity in the development and clinical validation of a multiplexed urine test for tuberculosis | Communications Medicine

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