PATHFAST TB LAM Ag Assay

Previous studies found no significant difference in LAM concentrations between raw and NALC–NaOH processed sputum, though supporting data are limited. All prior PATHFAST-LAM findings were based on retrospective analyses of stored samples, leaving the clinical utility for predicting treatment failure unvalidated prospectively. Studies from Kenya and South Africa confirmed that sputum LAM concentrations measured by PATHFAST-LAM correlate with culture-based bacterial load. The PATHFAST TB LAM Ag assay is a fully automated, cartridge-based chemiluminescent enzyme immunoassay that quantifies sputum LAM within one hour with minimal manual handling. The LAM extraction procedure involves NaOH treatment, heat at 100°C, neutralisation, and centrifugation, with a total extraction time of approximately 30 minutes. PATHFAST-LAM testing is performed on both raw sputum and NALC–NaOH processed sputum to evaluate the assay across different laboratory settings.