Diagnostic accuracy of the BD MAX MDR-TB assay on sputum and tongue swabs for <i>Mycobacterium tuberculosis</i> complex detection in adults under investigation for TB in South Africa

This study evaluates the accuracy of the BD MAXTM MDR-TB assay in detecting <i>Mycobacterium tuberculosis</i> complex using sputum and tongue swabs from individuals being assessed for tuberculosis (TB) in South Africa. Rapid and reliable TB diagnosis is crucial for early treatment and preventing transmission. The MAX Multi Drug Resistant Tuberculosis (MAX MDR-TB) assay is a fully automated molecular test that can simultaneously detect TB and drug resistance, offering a potentially faster and more efficient alternative for TB diagnosis. By assessing its performance on different specimen types, this study provides valuable insights into its reliability in clinical settings. Although the MAX MDR-TB assay demonstrated strong agreement with the Xpert MTB/RIF Ultra assay, it identified fewer TB cases. Tongue swabs were also shown to be a feasible specimen type for testing. This research contributes to global TB control efforts by evaluating advanced diagnostics that could streamline testing, reduce delays, and ultimately improve patient outcomes.