TABLE 4.
Corrected diagnostic performance of the FluoroType MTBDR assay for detection of rifampin and isoniazid resistance using Sanger sequencing and GenoType MTBDRplus as reference methodsa
| Specimen | Rifampin |
Isoniazid |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of indeterminate results | Sensitivity |
Specificity |
Positive LR (95% CI) | Negative LR (95% CI) | No. of indeterminate results | Sensitivity |
Specificity |
Positive LR (95% CI) | Negative LR (95% CI) | |||||
| % (95% CI) | No. of specimens positive/total no. tested | % (95% CI) | No. of specimens positive/total no. tested | % (95% CI) | No. of specimens positive/total no. tested | % (95% CI) | No. of specimens positive/total no. tested | |||||||
| All (n = 322) | 99.5 (96.6–100) | 183/184 | 99.3 (95.6–100) | 135/136 | 135.3 (19.2–953.3) | 0.01 (0.0008–0.04) | 100 (97.1–100) | 161/161 | 98.7 (95–99.8) | 154/156 | 78 (19.7–309.1) | 0 (0–NaN) | ||
| Sputum smear positive (n = 232) | 2 | 99.2 (95.8–100) | 130/131 | 100 (96.6–100) | 99/99 | Undefined (NaN–infinity) | 0.01 (0.001–0.05) | 2 | 100 (97–100) | 119/119 | 99.1 (95.1–100) | 110/111 | 111.1 (15.8–781.1) | 0 (0–NaN) |
| Sputum smear negative (n = 90) | 0 | 100 (93–100) | 53/53 | 97.3 (85.8–99.9) | 36/37 | 37.03 (5.4–255.8) | 0 (0–NaN) | 3 | 100 (91.6–100) | 42/42 | 97.8 (88.2–99.9) | 44/45 | 45.5 (6.48–312.5) | 0 (0–NaN) |
a
Definitions of abbreviations: CI, confidence intervals; LR, likelihood ratio; NaN, the calculation could not be performed because the values entered included one or more instances of zero.