Novel LAM Assay Shown Satisfactory Results in the Detection of Tuberculosis
Luo X, Xin K, Lai F, Xie Z, Pang X, Huang Y, Ma Q, Zheng Y, et al. (10 authors)
Infection and drug resistance · 2025-11
Abstract
Background Diagnosing tuberculosis (TB) infection remains a challenge for clinicians. According to recommendations from the World Health Organization (WHO), lipoarabinomannan (LAM) testing can be used to diagnose TB infection in individuals. A new generation of urinary LAM testing is now available. However, studies on its accuracy are limited and warrant further exploration. Objective This study aims to evaluate the accuracy of a new urinary LAM testing using LAM for diagnosing TB infection. Methods A cross-sectional study was conducted at the Fourth People's Hospital of Nanning, China. Participants were enrolled from December 2023 to May 2024. Fresh urine samples were collected from the participants and tested using LAM. The diagnostic accuracy of the LAM was compared with other tests for Mycobacterium tuberculosis (sputum culture, sputum smear or molecular biology testing). We compared the positive rates of different TB detection methods to evaluate the effectiveness of LAM. In the comparative analysis, the 95% confidence interval was calculated using the Wilson score method. The kappa value was computed, and the corresponding P-value was reported. Results The positive agreement rate of LAM was 64.37%, the negative agreement rate was 94.29%, and the overall agreement rate was 80.73%. The Kappa value was 0.6013, indicating good consistency between the test reagent and the reference method. Conclusion LAM can be used for the diagnosis of TB. It provides diagnostic information quickly, easily, and cost-effectively, particularly showing good performance in diagnosing TB.