Development and evaluation of the phenotypic 2G test to detect drug-resistant TB.

ABSTRACT:

Background

Early diagnosis of TB with drug susceptibility testing (DST) is critical to achieve successful treatment outcomes. We aimed to develop and test a novel colorimetric, 12-well, thin-layer agar-based test to assess its accuracy for TB diagnosis and DST in a clinical setting in Southern Mozambique.

Methods

Development of the first prototype of the second generation (2G) test in the laboratory setting followed by a cross-sectional diagnostic accuracy study with consecutive recruitment of subjects with microbiologically confirmed TB using GeneXpert MTB/RIF Ultra.

Results

In the laboratory setting, the 2G test showed 100% accuracy in detecting resistance of genotypically characterised drug-resistant Mycobacterium tuberculosis strains. In the clinical settin

SUBMITTER: Garcia JI 

PROVIDER: S-EPMC12617084 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature