Key result
Hain V2 and Nipro assays prove noninferior to Hain V1 for detecting rifampin and isoniazid resistance.
Why the study?
Newer-version line probe assays for rapid detection of rifampin and isoniazid resistance have not been evaluated against the WHO-endorsed Hain GenoType MTBDRplus version 1.
Do Hain Genotype MTBDRplus version 2 and Nipro NTM+MDRTB detection kit 2 perform noninferiorly to Hain version 1 for detecting rifampin and isoniazid resistance in tuberculosis?
Population
379 test strains and 644 sputum samples for MDR-TB detection
Comparison
Hain Genotype MTBDRplus version 2 and Nipro NTM+MDRTB detection kit 2 vs Hain GenoType MTBDRplus version 1
Design
Two-phase noninferiority study in two supranational reference laboratories
Authors
Loading...
Newer LPAs demonstrate noninferiority for RIF/INH resistance detection; leaves open need for prospective validation before routine clinical adoption.
Cross-Sectional (n=1,023)
Yes
Do Hain Genotype MTBDRplus version 2 and Nipro NTM+MDRTB detection kit 2 perform noninferiorly to Hain version 1 for detecting rifampin and isoniazid resistance in tuberculosis?
Hain V2 and Nipro line probe assays are noninferior to Hain V1 for detecting multidrug-resistant tuberculosis, supporting their use in WHO policy recommendations.
Nathavitharana et al. (2016) conducted a cross-sectional in Multidrug-resistant tuberculosis (MDR-TB) (n=1,023). Hain GenoType MTBDRplus version 2 and Nipro NTM+MDRTB line probe assays vs. Hain GenoType MTBDRplus version 1 was evaluated on Sensitivity and specificity for rifampin (RIF) and isoniazid (INH) resistance detection. Hain V2 and Nipro assays were noninferior to Hain V1 for detecting rifampin and isoniazid resistance, demonstrating phase 2 RIF sensitivities of 98.2% and 96.5% vs 97.1% for V1.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: