Analytical and clinical validation of a novel MeltPlus TB-NTM/RIF platform for simultaneous detection of Mycobacterium tuberculosis complex, Non-Tuberculous Mycobacteria and rifampicin resistance.

ABSTRACT:

Background

Rapid and accurate diagnosis of tuberculosis, particularly rifampin (RIF)-resistant tuberculosis (RR-TB) and Non-Tuberculous Mycobacteria (NTM), is essential for implementing appropriate proper therapy to benefit patients and improve TB/NTM patient management.

Methods

In this study, we developed a novel MeltPlus MTB-NTM/RIF platform, designed to simultaneously detect Mycobacterium tuberculosis complex (MTBC), NTM and RIF resistance. The platform was evaluated for its limit of detection (LOD) and specificity before clinical validation, followed by a prospective single-center study in patients with presumptive TB cases.

Results

The calculated LOD for MTBC, NTM and RIF susceptibility was found to be 10.31 CFU/mL, 57.55 CFU/mL and 48.584 CFU/mL, r

SUBMITTER: Wang Z 

PROVIDER: S-EPMC11847904 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature