Table 2.
The diagnostic performance of the Anyplex MTB/NTM for MTBC (A) and NTM (B) detection (A) MTBC detection.
|
(A) MTBC detection | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Specimens | Culture-positive |
Culture-negative |
Sensitivity (%) (95%CI) | Specificity (%) (95%CI) | PPV (%) (95%CI) | NPV (%) (95%CI) | Percent agreement (%) (95%CI) | ||
| PCR + | PCR - | PCR + | PCR - | ||||||
| Pulmonary | 580 | 156 | 248 | 4338 | 78.8 (75.7–81.7) |
94.6 (93.9–95.2) |
70 (66.8–73.2) |
96.5(96–97) | 92.4 (91.7–93.1) |
| Extrapulmonary | 265 | 59 | 220 | 3709 | 81.8 (77.1–85.8) |
94.4 (93.6–95.1) |
54.6 (50.1–59.1) |
98.4 (98–98.8) |
93.4 (92.7–94.2) |
| Overall | 845 | 215 | 468 | 8047 | 79.7 (77.2–82.1) |
94.5 (94–95) |
64.4 (61.7–67) |
97.4 (97–97.7) |
92.9 (92.4–93.4) |
|
(B) NTM detection | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Specimens | Culture-positive |
Culture-negative |
Sensitivity (%) (95%CI) | Specificity (%) (95%CI) | PPV (%) (95%CI) | NPV (%) (95%CI) | Percent agreement (%) (95%CI) | ||
| PCR + | PCR - | PCR + | PCR - | ||||||
| Pulmonary | 98 | 132 | 172 | 4920 | 42.6 (36.1–49.3) |
96.6 (96.1–97.1) |
36.3 (30.6–42.3) |
97.4 (96.9–97.8) |
94.3 (93.7–94.9) |
| Extrapulmonary | 26 | 20 | 42 | 4165 | 56.5 (41.1–71.1) |
99 (98.7–99.3) |
38.2 (26.7–50.8) |
99.5 (99.3–99.7) |
98.5 (98.2–98.9) |
| Overall | 124 | 152 | 214 | 9085 | 44.9 (39–51) |
97.7 (97.4–98) |
36.7 (31.5–42.1) |
98.4 (98.1–98.6) |
96.2 (95.8–96.6) |