ArticleTherapeutic advances in infectious disease
Diagnostic accuracy of the novel and biosafe molecular assay Orange G3 TBC compared to GeneXpert for tuberculosis diagnosis in resource-limited settings.
Article in Therapeutic advances in infectious disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
1 citing paper in PubMed.
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Tuberculosis (TB) remains a global public health priority, with 10.5 million new cases and 1.5 million deaths reported in 2023. Current diagnostic methods face limitations in sensitivity, biosafety, and accessibility, particularly in low-resource settings. Objective: This study evaluates the diagnostic accuracy of a novel, Polymerase Chain Reaction (PCR) platform (Orange G3 TBC), comparing it with the WHO-endorsed GeneXpert Ultra system in Oruro, Bolivia. Design: We conducted a randomized, double-blind study. Methods: The study included 71 clinical samples (67 sputum samples and 4 cerebrospinal fluid samples) from patients with presumptive TB. All samples were tested with GeneXpert Ultra and the Orange G3 TBC platform, which incorporates a unique biosafe processing system. Statistical analysis included sensitivity, specificity, predictive values (positive predictive value (PPV) and negative predictive value (NPV)), likelihood ratios (LR+ and LR-), and correlation measures. Results: Orange G3 TBC demonstrated strong performance metrics compared to GeneXpert Ultra: sensitivity = 90%, specificity = 97%, diagnostic efficiency = 96%, PPV = 82%, and NPV = 98%. Statistical analysis showed a high correlation between the two methods (Pearson's correlation = 0.834, Kappa = 0.832, LR+ = 27.3, LR- = 0.103). Conclusion: The Orange G3 TBC platform offers comparable diagnostic accuracy to GeneXpert Ultra. The system is adaptable to resource-limited settings, making it a viable alternative for TB diagnosis in endemic regions.
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