ArticleIJTLD open2025
Development and evaluation of the phenotypic 2G test to detect drug-resistant TB.
Article in IJTLD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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15 authors.
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Abstract
backgroundEarly 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.
methodsDevelopment 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.
resultsIn the laboratory setting, the 2G test showed 100% accuracy in detecting resistance of genotypically characterised drug-resistant
conclusionIn the clinical setting, the 2G test showed a low sensitivity versus Xpert and MGIT. The 2G test sensitivity was lower when frozen instead of fresh sputa was used. Despite these results, important information was collected to further improve this 2G test prototype and its implementation in resource-constrained settings.
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