METHODS FOR DUAL DETECTION AND DIFFERENTIATION OF INFECTION BY MYCOBACTERIUM TUBERCULOSIS COMPLEX AND NONTUBERCULOUS MYCOBACTERIA

摘要

This disclosure provides novel binary and ternary diagnostic tests with improved sensitivity and specificity for the presence of antigenic derivatives of lipo arabino mannan (LAM) present in biological fluids (e.g., sputum, serum, urine) of subjects infected with various mycobacterial pathogens, including M. tb and NTMs. The disclosed diagnostic tests detect and differentiate infection by Mycobacterium tuberculosis complex (MTBC) and nontuberculous mycobacteria (NTMs). The diagnostic tests detect different forms of LAM in the sample of patients, using capture antibodies that are either specific for TB, specific for NTMs or crossreactive with all forms of LAM, in conjunction with high-affinity species-specific or crossreactive detection antibodies.