TABLE 1.
Performance of FluoroType MTBDR and Genotype MTBDRplus for detection of M. tuberculosis complex from smear-positive and smear-negative sputum specimens compared to culture and Genotype MTBDRplus results obtained from the corresponding cultured isolatesa
| Specimen | FluoroType MTBDRb |
MTBDRplusc |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Sensitivity |
Specificity |
% PPV (95% CI) | % NPV (95% CI) | No. of invalid tests | Sensitivity |
% PPV (95% CI) | No. of invalid tests | ||||
| % (95% CI) | No. of specimens positive/total no. of samples tested | % (95% CI) | No. of specimens positive/total no. tested | % (95% CI) | No. of specimens positive/total no. tested | ||||||
| All (n = 448) | 96.11 (93.3–97.8) | 322/335 | 100 (95.6–100) | 105/105 | 100 (98.5–100) | 89 (81.6–93.8) | 8 | 97 (94.5–98.8) | 334/343 | 100 (98.6–100) | 0 |
| Sputum smear positive (n = 244) | 97.9 (94.9–99.2) | 232/237 | 100 (98.4–100) | 7 | 99.2 (96.8–99.9) | 242/244 (P = 0.24d) | 100 (98.0–100) | 0 | |||
| Sputum smear negative (n = 204) | 91.8 (84.1–96.2) | 90/98 (P = 0.009e) | 100 (96.6–100) | 105/105 | 100 (96–100) | 92.9 (86.5–96.9) | 1 | 92.3 (85.5–96.9) | 92/99 (P = 0.001,e P = 0.78d) | 100 (95–100) | 0 |
a
Definitions of abbreviations: CI, confidence interval; NPV, negative predictive value; PPV, positive predictive value.
b
Fluorotype MTBDR assay done on sputum specimens.
c
Genotype MTBDRplus done on sputum specimens.
d
P values comparing FluoroType MTBDR and Genotype MTBDRplus results within smear groups.
e
Assay-specific P values comparing results for smear-positive and smear-negative specimens.