Table 3.
Sensitivity and specificity of the hyplex® TBC test
| PCR results | |||||
|---|---|---|---|---|---|
| positive (n) | negative (n) | total (n) | sensitivity (%) | specificity (%) | |
| ALL SAMPLES | 243 | 314 | 557 | ||
| TB samples | 241 | 49 | 290 | 83.1 | |
| smear-positive | 213 | 15 | 228 | 93.4 | |
| smear-negative | 28 | 34 | 62 | 45.1 | |
| non-TB samples | 2 | 265 | 267 | 99.25 | |
| non-NTM | 1 | 246 | 247 | 99.5 | |
| NTM | 1 | 19 | 20 | 95.0 | |
| RESPIRATORY SAMPLES | 237 | 257 | 494 | ||
| TB samples | 234 | 44 | 278 | 84.2 | |
| smear-positive | 210 | 14 | 224 | 93.7 | |
| smear-negative | 24 | 30 | 54 | 44.4 | |
| non-TB samples | 2 | 213 | 215 | 99.1 | |
| non-NTM | 1 | 195 | 196 | 99.5 | |
| NTM | 1 | 18 | 19 | 94.7 | |
| NON RESPIRATORY SAMPLES | 11 | 53 | 64 | ||
| TB samples | 11 | 1 | 12 | 91.6 | |
| smear-positive | 4 | 0 | 4 | 100 | |
| smear-negative | 7 | 1 | 8 | 87.5 | |
| non-TB samples | 0 | 52 | 52 | 100 | |
| non-NTM | 0 | 51 | 51 | 100 | |
| NTM | 0 | 1 | 1 | 100 | |