Clinical evaluation of the diagnostic performances and treatment monitoring of the new PATHFAST TB LAM Ag assay in sputum specimens of patients with tuberculosis or with nontuberculous mycobacteria pulmonary disease

Effective monitoring of the treatment response is essential for successful tuberculosis (TB) management as prolonged therapies require accurate evaluation to prevent relapse, treatment failure, or drug resistance. This study highlights the diagnostic and treatment-monitoring potential of the PATHFAST TB LAM Ag assay, which quantifies lipoarabinomannan (LAM) concentrations in sputum samples and correlates with bacterial load. For the first time, we also demonstrate the assay's applicability for detecting and monitoring nontuberculous mycobacterial (NTM) pulmonary diseases, which are increasingly prevalent in industrialized countries. The semi-automated, rapid format (<17 minutes) of the PATHFAST TB LAM Ag assay provides a simple and reliable approach for assessing bacillary load during treatment, representing a promising tool for improving patient management and diagnostic efficiency in both TB and NTM-PD.