TABLE 3.
Device performance using serum for all sites, stratified by days p.s.o.a
| Day p.s.o. | Test article | No. of specimens that were: |
Sensitivity (95% CI) (%) | Specificity (95% CI) (%) | |||
|---|---|---|---|---|---|---|---|
| TP | FN | FP | TN | ||||
| 0–3 | Panbio RDT | 120 | 130 | 213 | 371 | 48.0 (41.7–54.4) | 63.5 (59.5–67.4) |
| 4–8 | 145 | 17 | 56 | 90 | 89.5 (83.7–93.8) | 61.6 (53.2–69.6) | |
| 9–14 | 64 | 1 | 9 | 17 | 98.5 (91.7–100.0) | 65.4 (44.3–82.8) | |
| 15+ | 248 | 5 | 242 | 339 | 98.0 (95.5–99.4) | 58.3 (54.2–62.4) | |
| 4–14 | 209 | 18 | 65 | 107 | 92.1 (87.8–95.2) | 62.2 (54.5–69.5) | |
| 0–3 | SD RDT | 206 | 51 | 57 | 429 | 80.2 (74.8–84.9) | 88.3 (85.1–91.0) |
| 4–8 | 159 | 11 | 24 | 93 | 93.5 (88.7–96.7) | 79.5 (71.0–86.4) | |
| 9–14 | 69 | 1 | 2 | 23 | 98.6 (92.3–100.0) | 92.0 (74.0–99.0) | |
| 15+ | 232 | 15 | 73 | 495 | 93.9 (90.2–96.6) | 87.1 (84.1–89.8) | |
| 0–14 | 434 | 63 | 83 | 545 | 87.3 (84.1–90.1) | 86.8 (83.9–89.3) | |
| 0–3 | IgM ELISA | 83 | 166 | 41 | 540 | 33.3 (27.5–39.6) | 92.9 (90.6–94.9) |
| 4–8 | 143 | 28 | 19 | 124 | 83.6 (77.2–88.8) | 86.7 (80.0–91.8) | |
| 9–14 | 68 | 2 | 1 | 24 | 97.1 (90.1–99.7) | 96.0 (79.7–99.9) | |
| 15+ | 199 | 48 | 41 | 530 | 80.6 (75.1–85.3) | 92.8 (90.4–94.8) | |
| 4–14 | 211 | 30 | 20 | 148 | 87.6 (82.7–91.4) | 88.1 (82.2–92.6) | |
| 0–3 | IgG ELISA | 40 | 216 | 45 | 530 | 15.6 (11.4–20.7) | 92.2 (89.7–94.2) |
| 4–8 | 79 | 90 | 18 | 127 | 46.7 (39.0–54.6) | 87.6 (81.1–92.5) | |
| 9–14 | 56 | 14 | 2 | 25 | 80.0 (68.7–88.6) | 92.6 (75.7–99.1) | |
| 15+ | 226 | 24 | 56 | 508 | 90.4 (86.1–93.8) | 90.1 (87.3–92.4) | |
| 4–14 | 135 | 104 | 20 | 152 | 56.5 (49.9–62.9) | 88.4 (82.6–92.8) | |
a
The numbers of true positives (TP), false negatives (FN), false positives (FP), and true negatives (TN) of the test article when compared with the reference method are provided, and sensitivity [TP/(TP+FN)] and specificity [TN/(TN+FP)] are calculated. The upper and lower bounds for confidence intervals (95%) are also shown.