Table 1.
Accuracy of Bioeasy™ rapid immunochromatographic test at point of care and in the laboratory
| Readings at 15’ | Readings at 30’ | |||
|---|---|---|---|---|
| Whole blood/POCa | Serum/Laboratoryb | Whole blood/POCa | Serum/Laboratoryb | |
| Sensitivity | 76.7%c | 82.2%c | 78.3%c | 84.9%c |
| (95%CI) | (68.0–84.1) | (74.1–88.6) | (69.9–85.3) | (77.2–90.8) |
| Specificity | 87.0%d | 100.0%d | 87.5%d | 95.8%d |
| (95% CI) | (66.4–97.2) | (85.8–100.0) | (67.6–97.3) | (78.9–99.9) |
| PPV | 96.7% | 100.0% | 96.9% | 99.0% |
| (95%CI) | (90.8–99.3) | (96.3% - 100.0) | (91.2–99.4) | (95.4–99.8) |
| NPV | 42.6% | 53.3% | 44.7% | 56.1% |
| (95%CI) | (28.3–57.8) | (37.9–68.3) | (30.2–59.9) | (39.8–71.5) |
| LR+ | 5.9 | 19.8e | 6.27 | 20.4 |
| (95%CI) | (2.0–17.0) | (2.9–135.1) | (2.2–18.1) | (3.0–139.0) |
| LR- | 0.27 | 0.18 | 0.25 | 0.16 |
| (95%CI) | (0.19–0.39) | (0.12–0.26) | (0.17–0.36) | (0.10–0.24) |
POC point of care, 95% CI 95% confidence interval, PPV positive predictive value, NPV negative predictive value, LR+ positive likelihood ratio, LR- negative likelihood ratio
aPerformed with whole blood
bPerformed with serum
cP-value <0.01
dP-value >0.05 of χ2 McNemar test
eLR+ calculated using 97.9% specificity