A. Performance characteristics of the GenoType® MTBDRplusassay for the detection of RIF- and INH-resistance in comparison to drug-susceptibility test results using the MGIT BACTEC 960. | |||||||||
---|---|---|---|---|---|---|---|---|---|
INH Resistance | RIF Resistance | ||||||||
MGIT AST Result | MGIT AST Result | ||||||||
Specimen Type | GenoType® MTBDR plus Result | + | - | Sensitivity (%) | Specificity (%) | + | - | Sensitivity (%) | Specificity (%) |
AFB+ Sputum | + (Resistant) | 27 | 0 | 93.1 | 100 | 19 | 0 | 100 | 100 |
- (Sensitive) | 2 | 135 | 0 | 145 | |||||
Stored Isolate | + | 14 | 0 | 100 | 100 | 6 | 0 | 100 | 100 |
- | 0 | 36 | 0 | 44 | |||||
All Specimens | + | 41 | 0 | 95.3 | 100 | 25 | 0 | 100 | 100 |
- | 2 | 171 | 0 | 189 | |||||
B. Performance characteristics of the GenoType ® MTBDR plus assay for the detection of MDR-TB in comparison to drug-susceptibility test results using the MGIT BACTEC 960. | |||||||||
MDR-TB MGIT AST Result | |||||||||
Specimen Type | GenoType ® MTBDR plus Result | + | - | Sensitivity (%) | Specificity (%) | ||||
AFB+ Sputum | + (Resistant) | 12 | 0 | 92.3 | 100 | ||||
- (Sensitive) | 1 | 151 | |||||||
Stored Isolate | + | 5 | 0 | 100 | 100 | ||||
- | 0 | 45 | |||||||
All Specimens | + | 17 | 0 | 94.4 | 100 | ||||
- | 1 | 196 |