TABLE 3.
Diagnostic accuracy clinical study: accuracy of single rapid tests using as a gold standard four cultures performed from two sputum samples
| Prospective diagnostic accuracy | Compared to 4 culture results (2 MGIT, 2 LJ) performed on 2 sputum specimens |
AFB Sm+/Cx+, Sensitivity (n/n [%] [95% CI])a | AFB Sm−/Cx+, Sensitivity (n/n [%] [95% CI]) | |||
|---|---|---|---|---|---|---|
| Sensitivity (n/n [%] [95% CI]) | Specificity (n/n [%] [95% CI]) | PPV (n/n [%] [95% CI]) | NPV (n/n [%] [95% CI]) | |||
| Sputum 1 result vs culture gold standard (n = 336 participants) | ||||||
| Genedrive, prehomogenization, sputum 1 | 44/97 (45.4) (35.2–55.8) | 233/239 (97.5) (94.6–99.1) | 44/50 (88.0) (75.7–95.5) | 233/286 (81.5) (75.7–85.8) | 44/75 (58.7) (46.7–70.0) | 0/22 (0) (0–15.4) |
| Genedrive, posthomogenization, sputum 1 | 57/97 (58.8) (48.3–68.7) | 233/239 (97.5) (94.6–99.1) | 57/63 (90.5) (80.4–96.4) | 233/273 (85.3) (80.6–89.3) | 56/75 (74.7) (63.3–84.0) | 1/22 (4.5) (0.0–22.8) |
| Xpert MTB/RIF, sputum 1 | 89/97 (91.8) (84.4–96.4) | 234/239 (97.9) (95.2–99.3) | 89/94 (94.7) (88.0–98.3) | 234/242 (96.7) (93.6–98.6) | 74/75 (98.7) (92.8–99.9) | 15/22 (68.2) (45.1–86.1) |
| AFB smear microscopy, sputum 1 | 75/97 (77.3) (67.7–85.2) | 239/239 (100) (98.5–100) | 75/75 (100) (95.1–100) | 239/261 (91.6) (87.5–94.6) | N/A | N/A |
| Sputum 2 result vs culture gold standard (n = 326 participants) | ||||||
| Genedrive, pellet, sputum 2 | 64/95 (67.4) (57.0–76.6) | 225/231 (97.4) (94.4–99.0) | 64/70 (97.0) (81.5–96.6) | 225/256 (87.9) (83.3–91.6) | 63/74 (85.14) (74.9–92.3) | 1/21 (4.7) (0–23.8) |
a
Cx, culture; Sm, smear; N/A, not available.