Multicentric validation of the PathoDetect™ MTB RIF & INH assay for simultaneous detection of Mycobacterium tuberculosis, & drug resistance to rifampicin & isoniazid in presumptive pulmonary tuberculosis & drug-resistant TB patients.

ABSTRACT: Background & objectives Tuberculosis (TB) remains a major global health concern, with India accounting for 26 per cent of the global burden. Despite advances, access to rapid molecular diagnostics is limited, and the assays currently used in National TB Elimination Programme (NTEP) do not detect isoniazid (INH) resistance upfront. PathoDetect™ MTB RIF & INH is an indigenous closed-system assay that simultaneously detects Mycobacterium tuberculosis (MTB) and resistance to rifampicin (RIF) and INH. This study evaluated its diagnostic characteristics. Methods In this cross-sectional multicenter study conducted at six TB reference laboratories in India, 1039 participants were enrolled (718 presumptive pulmonary TB, 321 presumptive multidrug resistant TB; MDR-TB). PathoDetect™'s discriminatory

SUBMITTER: Choudhary H 

PROVIDER: S-EPMC12550425 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature