Simultaneous detection and differentiation of <i>Mycobacterium tuberculosis</i> and nontuberculous mycobacteria in smear-negative sputum by a multiplex PCR assay: a clinical feasibility study.

ABSTRACT: Accurate and rapid differentiation of Mycobacterium tuberculosis (M. tuberculosis) and nontuberculous mycobacteria (NTM) remains challenging, especially in smear-negative samples. Routine diagnostic methods often lack specificity and rapidity, highlighting the urgency of developing applicative molecular diagnostics to guide clinical management and improve patient outcomes. We developed and validated a multiplex PCR assay employing TaqMan probes targeting the IS6110 and rpoB genes to simultaneously detect M. tuberculosis and 23 NTM species in a single reaction, while avoiding cross-reactivity. Analytical performance was assessed using reference strains, and clinical feasibility was evaluated in a prospective, single-center pilot study involving 96 smear-ne

SUBMITTER: Xie L 

PROVIDER: S-EPMC12210955 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature