Multi-center Study to Assess the Non-inferiority of Nipro NTM + MDRTB and Hain Genotype Mtbdrplus V2 Line Probe Assays Compared to Hain Genotype Mtbdrplus V1

New diagnostic methods have provided a promising solution for rapid and reliable detection of drug-resistant TB strains. The aim of this study was to evaluate the performance of the MeltPro TB assay in identifying multidrug-resistant (MDR-) and extensively drug-resistant tuberculosis (XDR-TB) patients from sputum samples. The MeltPro TB assay was evaluated using sputum samples from 2057 smear-positive TB patients. Phenotypic Mycobacterial Growth Indicator Tube (MGIT) 960 drug susceptibility testing served as a reference standard. The sensitivity of the MeltPro TB assay was 94.2% for detecting resistance to rifampicin and 84.9% for detecting resistance to isoniazid. For second-line drugs, the assay showed a sensitivity of 83.3% for ofloxacin resistance, 75.0% for amikacin resistance, and 63.5% for kanamycin resistance. However, there was a significant difference for detecting kanamycin resistance between the two pilot sites in sensitivity, which was 53.2% in Guangdong and 81.5% in Shandong (P = 0.015). Overall, the MeltPro TB assay demonstrated good performance for the detection of MDR- and XDR-TB, with a sensitivity of 86.7% and 71.4%, respectively. The MeltPro TB assay is an excellent alternative for the detection of MDR- and XDR-TB cases in China, with high accuracy, short testing turn-around time, and low unit price compared with other tests.

show abstract

Multi-center Study to Assess the Non-inferiority of Nipro NTM + MDRTB and Hain Genotype Mtbdrplus V2 Line Probe Assays Compared to Hain Genotype Mtbdrplus V1

Cited by 3 publications

References 0 publications

Laboratory Diagnosis of Tuberculosis

Laboratory Diagnosis of Tuberculosis

Drug Resistance Assays for Mycobacterium tuberculosis

Rapid diagnosis of MDR and XDR tuberculosis with the MeltPro TB assay in China

Contact Info

Product

Resources

About