Evaluation of Urine TB-Lipoarabinomannan (LAM) Ag FIA as a Point-of-Care Test for Active Tuberculosis Diagnosis Among Suspected TB Patients in Malaysia: A Cross-Sectional Study Protocol (Preprint)

<sec> <title>BACKGROUND</title> Tuberculosis (TB) remains a global public health issue. Despite the availability of diagnostic tools, TB diagnosis in resource-limited settings remains challenging. Urine Lipoarabinomannan (LAM), a novel point-of-care (POC) urine test, has shown promising results among immunocompromised populations. </sec> <sec> <title>OBJECTIVE</title> : This study aims to evaluate the diagnostic accuracy of urine TB-LAM Antigen (Ag) Fluorescence Immunoassay (FIA) against standard diagnostic methods among general TB-suspected patients in Malaysian public health clinics. </sec> <sec> <title>METHODS</title> A cross-sectional diagnostic accuracy study will be conducted in ten public health clinics across Malaysia. The study population includes patients aged five years and above who present with symptoms suggestive of TB. The index test (urine TB-LAM FIA) will be compared against a composite reference standard comprising clinical diagnosis and bacteriological confirmation using Xpert MTB/RIF assay and culture. A total of 2,000 patients will be consecutively recruited. Sensitivity, specificity, predictive values, and likelihood ratios will be calculated. </sec> <sec> <title>RESULTS</title> This protocol outlines methodology including study design, test procedures, data collection, statistical analysis, and ethical considerations. Findings will support the integration of urine TB-LAM as a POC TB diagnostic tool in primary care. </sec> <sec> <title>CONCLUSIONS</title> If the index test is shown to be accurate, the urine TB-LAM test may improve early TB detection and reduce disease transmission, particularly in high-burden settings. </sec> <sec> <title>CLINICALTRIAL</title> Research Registration: National Medical Research Register (NMRR ID-24-00445-KR0) </sec>