Table 2.
Sensitivity and specificity of endorsed molecular assays for rapid detection of drug-resistant TB
| Assay | Detection of drug resistance | Sensitivity % (95% confidence interval) |
Specificity % (95% confidence interval) |
References |
|---|---|---|---|---|
| Xpert MTB/RIF | RIF | 95 (90–97) | 98 (97–99) | 44* |
| Xpert Ultra | RIF | 92.7 (80.1–98.5) | 98 (92.8–99.9) | 58* |
| GenoType MTBDRplus | RIF | Smear positive sample: 88.2 (72.6–96.7) | Smear positive sample: 89.5 (75.2–97.1) | 77* |
| Smear negative and culture positive direct sample: 100 (29.2–100) | Smear negative and culture positive direct sample: 63.6 (30.8–89.1) | |||
| INH | Smear positive sample: 91.7 (77.5–98.3) | Smear positive sample: 97.2 (85.5–99.9) | ||
| Smear negative and culture positive direct sample: 60 (14.7–94.7) | Smear negative and culture positive direct sample: 100 (66.4–100) | |||
| MDR-TB (RMP&INH) | Smear positive sample: 96.4 (81.7–99.9) | Smear positive sample: 100 (88.8–100) | ||
| Smear negative and culture positive direct sample: 100 (15.8–100) | Smear negative and culture positive direct sample: 100 (47.8–100) | |||
| GenoType MTBDRsl | FLQ | 100 (95.8–100) | 98.9 (96.1–99.9) | 84* |
| AMK | 93.8 (79.2–99.2) | 98.5 (95.5–99.7) | ||
| KAN | 89.2 (79.1–95.6) | 98.5 (95.5–99.7) | ||
| CPM | 86.2 (68.3–96.1) | 95.9 (92.2–98.2) |
44*: reference standard was phenotypic culture-based DST
58*: results were compared with phenotypic susceptibility testing and Xpert MTB/RIF
77*: results were compared with the conventional liquid culture based reference standard method, BACTEC MGIT 960 culture and DST
84*: results were compared with phenotypic DST