Original Article
Evaluation of GenoType MTBDRplus assay for rapid detection of isoniazid- and rifampicin-resistance in Mycobacterium tuberculosis isolates from diabetes mellitus patients
Abstract
Background: To evaluate the performance of GenoType MTBDRplus assay for rapid detection of isoniazid (INH)- and rifampicin (RIF)-resistance in Mycobacterium tuberculosis (M.TB) isolates from diabetes mellitus (DM) patients, a retrospective study was conducted.
Methods: Between May, 2012 and Sep, 2016, 227 tuberculosis (TB) patients with DM were enrolled in the study. Culture and phenotypic drug susceptibility test were performed in all cases. The GenoType MTBDRplus assay were done on sputum or culture specimens and carried out according to manufacturer’s instructions. The sensitivity, specificity, false positive ratio, false negative ratio and diagnostic odds ratio for detecting INH- and RIF-resistance by GenoType MTBDRplus assay were calculated using the phenotypic drug susceptibility test as the gold standard.
Results: The total sensitivity, specificity, false positive ratio, false negative ratio and diagnostic odds ratio of GenoType MTBDRplus assay: (I) for RIF-resistance detection, were 96.7% (83.3%, 99.4%), 97.5% (94.2%, 98.9%), 38.1 (16.0, 90.7), 0.034 (0.005, 0.235) and 1,113.6 (125.6, 9,873.5), respectively; (II) for INH-resistance detection, were 82.1% (64.4%, 92.1%), 91.9% (87.3%, 95.0%), 10.2 (6.2, 16.8), 0.194 (0.088, 0.43) and 52.3 (17.5, 156.2), respectively; (III) for multiple drug resistance (MDR) detection, were 92.9% (68.5%, 98.7%), 96.2% (92.8%, 98.0%), 24.7 (12.3, 49.5), 0.074 (0.011, 0.491) and 333.1 (38.7, 2,868.7), respectively.
Conclusions: GenoType MTBDRplus assay is highly sensitive and specific for rapid diagnosis of MDR-TB in DM patients. The application of this assay could be considered for some settings. Further studies were needed to assess the role and value of GenoType MTBDRplus assay in treatment for MDR-TB with DM patients.
Methods: Between May, 2012 and Sep, 2016, 227 tuberculosis (TB) patients with DM were enrolled in the study. Culture and phenotypic drug susceptibility test were performed in all cases. The GenoType MTBDRplus assay were done on sputum or culture specimens and carried out according to manufacturer’s instructions. The sensitivity, specificity, false positive ratio, false negative ratio and diagnostic odds ratio for detecting INH- and RIF-resistance by GenoType MTBDRplus assay were calculated using the phenotypic drug susceptibility test as the gold standard.
Results: The total sensitivity, specificity, false positive ratio, false negative ratio and diagnostic odds ratio of GenoType MTBDRplus assay: (I) for RIF-resistance detection, were 96.7% (83.3%, 99.4%), 97.5% (94.2%, 98.9%), 38.1 (16.0, 90.7), 0.034 (0.005, 0.235) and 1,113.6 (125.6, 9,873.5), respectively; (II) for INH-resistance detection, were 82.1% (64.4%, 92.1%), 91.9% (87.3%, 95.0%), 10.2 (6.2, 16.8), 0.194 (0.088, 0.43) and 52.3 (17.5, 156.2), respectively; (III) for multiple drug resistance (MDR) detection, were 92.9% (68.5%, 98.7%), 96.2% (92.8%, 98.0%), 24.7 (12.3, 49.5), 0.074 (0.011, 0.491) and 333.1 (38.7, 2,868.7), respectively.
Conclusions: GenoType MTBDRplus assay is highly sensitive and specific for rapid diagnosis of MDR-TB in DM patients. The application of this assay could be considered for some settings. Further studies were needed to assess the role and value of GenoType MTBDRplus assay in treatment for MDR-TB with DM patients.
