Toward a National Tuberculosis Lateral-Flow Urine Lipoarabinomannan (LF-LAM) External Quality Assessment Program in Thailand: Feasibility Demonstration Through Panel Development, Validation, and Proficiency Testing, March 2025–April 2026

Background: The World Health Organization and the Thailand National HIV Treatment Guidelines recommend the use of lateral flow urine lipoarabinomannan (LF-LAM) testing for tuberculosis (TB) detection in people living with HIV (PLHIV) with advanced HIV disease who have signs and symptoms of TB or are seriously ill. As Thailand decentralizes LF-LAM testing, a robust quality assurance system is needed to maintain diagnostic accuracy across healthcare levels. Methods: We developed, validated, and rolled out Thailand’s first national external quality assessment (EQA) and internal quality control (IQC) framework for urinary TB LF-LAM testing. Pre-characterized urine panels were distributed to 20 provinces spanning 12 health regions nationwide across four cycles from 2025 to 2026. Longitudinal monitoring of reporting compliance, pass rates, and failure modes was performed across 30 participating sites in 2025 and 64 and 42 sites in 2026 Rounds 1 and 2, respectively. Results: IQC coverage increased from 7 to 68 facilities by the final cycle in January 2026, with satisfaction rates of 85.7–100%. EQA pass rates showed a stepwise improvement: 83.3% in Round 1/2025, 93.1% in Round 2/2025 and 97.5% and 98.4% in the 2026 rounds (p < 0.05). Initial failures were primarily due to false-positive interpretation of Grade 1 bands and deviation in the reading window. Targeted retraining and standardized reference match-cards reduced user-dependent false-positive results to 0% in the final cycle. Conclusions: A centralized national quality assurance framework may be an effective mechanism for standardizing the reliability and interpretation of point-of-care LF-LAM testing across decentralized healthcare systems. This approach strengthens diagnostic capacity at peripheral facilities and supports the safe expansion of TB services for PLHIV.