TABLE 2.
Performance of FluoroType MTBDR and Genotype MTBDRplus for detection of rifampin and isoniazid resistance from smear-positive and smear-negative sputum specimens compared to GenoType MTBDRplus results obtained from DNA extracts from the corresponding cultured isolatesa
| Specimen | FluoroType MTBDRb |
Genotype MTBDRplusc |
||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rifampin |
Isoniazid |
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) | No. of indeterminate tests | 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 | % (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) | 97.8 (94.1–99.3) | 178/182 | 95.6 (90.4–98.2) | 132/138 | 22.5 (10.3–49.2) | 0.02 (0.009–0.06) | 98.8 (95.1–99.8) | 158/160 | 97 (92.6–98.9) | 152/157 | 32 (13.5–75.8) | 0.01 (0.003–0.05) | 97.3 (93.5–99) | 181/186 | 91.5 (85.3–95.3) | 129/141 | 11.4 (6.7–19.6) | 0.03 (0.01–0.07) | 96.4 (92–98.5) | 162/168 | 96.8 (92.3–98.8) | 151/156 | 30.1 (12.7–71.3) | 0.04 (0.02–0.08) | ||||
| Sputum smear positive (n = 232) | 2 | 96.9 (92.4–99.2) | 127/131 | 97 (91.4–99.4) | 96/99 | 32.3 (10.5–97.5) | 0.03 (0.01–0.08) | 2 | 98.3 (94.1–99.8) | 117/119 | 97.3 (92.3.–99.4) | 108/111 | 36.4 (11.9–111.1) | 0.02 (0.004–0.07) | 0 | 97.1 (92.2–99.1) | 132/136 (P = 0.95d) | 95.3 (88.8–98.3) | 101/106 | 20.58 (8.74–48.4) | 0.03 (0.01–0.08) | 0 | 97.6 (92.7–99.4) | 123/126 (P = 0.69d) | 99.1 (92.7–99.4) | 115/116 | 113.3 (16.1–797.3) | 0.03 (0.008–0.07) |
| Sputum smear negative (n = 90) | 0 | 100 (93–100) | 51/51 (P = 0.21e) | 92.3 (79.1–98.4) | 36/39 | 13 (4.4–38.6) | 0 (0–NaN) | 3 | 100 (91.4–100) | 41/41 (P = 0.40e) | 95.7 (85.2–99.5) | 44/46 | 23.3 (5.93–89.2) | 0 (0–NaN) | 6 | 98 (88–99.9) | 49/50 (P = 0.73,e P = 0.31d) | 80 (62.5–90.9) | 28/35 | 4.9 (2.5–9.5) | 0.03 (0.003–0.18) | 9 | 92.8 (79.4–98.1) | 39/42 (P = 0.15,e P = 0.08d) | 90 (75.4–96.7) | 36/40 | 9.3 (3.7–23.6) | 0.08 (0.03–0.24) |
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.
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.