Table 3 Sensitivity, specificity, PPV and NPV of SmartRub® device in phase I (part 1 and 2), II and III
Sensitivity % (95% CI) | Specificity % (95% CI) | PPV % (95% CI) | NPV % (95% CI) | |
|---|---|---|---|---|
Phase 1 (bottle only) | ||||
Gel | 90.7 (86.2–94.1) | 100.0 (98.5–100.0) | 99.4 (96.5–99.8) | 91.0 (87.2–93.6) |
Rinse | 99.2 (97.2–99.9) | 91.0 (86.8–94.2) | 91.7 (88.2–94.2) | 99.1 (96.7–99.8) |
Phase 1 (bottle and wristband) | ||||
Gel | 92.2 (87.6–95.5) | 100.0 (98.2–100.0) | 99.3 (96.0–99.8) | 92.2 (88.1–94.7) |
Rinse | 96.1 (92.4–98.3) | 98.0 (95.1–99.5) | 98.0 (94.9–99.2) | 96.2 (92.7–98.0) |
Phase 2 | ||||
Gel | 91.8 (87.6–94.9) | 83.5 (78.3–88.0) | 84.8 (80.7–88.1) | 91.0 (86.9–93.9) |
Rinse | 97.5 (94.7–99.1) | 81.2 (75.7–86.0) | 83.9 (80.0–87.1) | 97.0 (93.7–98.6) |
Feedback off | 91.8 (87.6–94.9) | 82.4 (77.0–86.9) | 83.9 (79.8–87.3) | 90.9 (86.8–93.9) |
Feedback on | 97.5 (94.7–99.1) | 82.4 (77.0–87.0) | 84.7 (80.8–88.0) | 97.1 (93.7–98.7) |
Phase 3 | ||||
Total | 96.8 (93.8–98.6) | 98.3 (95.7–99.5) | 98.3 (95.6–99.3) | 96.8 (93.9–98.4) |