Ther Adv Infect Dis. 2025 Oct 21;12:20499361251386681. doi: 10.1177/20499361251386681. eCollection 2025 Jan-Dec.
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.
PMID:41147006 | PMC:PMC12553880 | DOI:10.1177/20499361251386681
