Table 1.
Analytical sensitivities, specificities and predictive parameters for SARS-CoV-2 antibody detection.
| Positive serum samplesa | Negative serum samplesa | Sensitivity (95% CI) | Specificity (95% CI) | PPV (95% CI) | NPV (95% CI) | Accuracy (95% CI) | Diagnostic odds ratio (95% CI) | Youden's index | |
|---|---|---|---|---|---|---|---|---|---|
| MENARINI® IgM | 20/63 | 58/61 | 31.7% (21.6–44.0) | 95.1% (86.5–98.3) | 87.0% (67.9–95.5) | 57.4% (47.7–66.6) | 62.9% (54.1–70.9) | 8.99 (2.51–32.21) | 0.3 |
| MENARINI® IgG | 46/63 | 58/61 | 73.0% (61.0–82.4) | 95.1% (86.5–98.3) | 93.9 (83.5–97.9) | 77.3 (66.7–85.3) | 83.9% (76.4–89.3) | 52.31 (14.44–189.47) | 0.7 |
| MENARINI® Combined IgM or IgG | 49/63 | 57/61 | 77.8% (66.1–86.3) | 93.4% (84.3–97.4) | 92.5% (82.1–97.0) | 80.3% (69.6–87.9) | 85.5% (78.2–90.6) | 49.88 (15.40–161.50) | 0.7 |
| PALEX® IgM | 42/63 | 56/61 | 66.7% (54.4–77.1) | 91.8% (82.2–96.4) | 89.4% (77.4–95.4) | 72.7% (61.9–81.4) | 79.0% (71.0–85.3) | 22.40 (7.81–64.28) | 0.6 |
| PALEX® IgG | 56/63 | 56/61 | 88.9% (78.8–94.5) | 91.8% (82.2–96.4) | 91.8% (82.2–96.4) | 88.9% (78.8–94.5) | 90.3% (83.8–94.4) | 89.60 (26.83–299.26) | 0.8 |
| PALEX® Combined IgM or IgG | 56/63 | 52/61 | 88.9% (78.8–94.5) | 85.2% (74.3–92.0) | 86.2% (75.7–92.5) | 88.1% (77.5–94.1) | 87.1% (80.1–91.9) | 46.22 (16.06–133.07) | 0.7 |
| VIRCLIA® IgM | 38/63 | 58/61 | 60.3% (48.0–71.5) | 95.1% (86.5–98.3) | 92.7% (80.6–97.5) | 69.9% (59.3–78.7) | 77.4% (69.3–83.9) | 29.39 (8.29–104.17) | 0.6 |
| VIRCLIA® IgG | 53/63 | 59/61 | 84.1% (73.2–91.1) | 96.7% (88.8–99.1) | 96.4% (87.7–99.0) | 85.5% (75.3–91.9) | 90.3% (83.8–94.4) | 156.35 (32.76–746.18) | 0.8 |
| VIRCLIA® Combined IgM or IgG | 54/63 | 58/61 | 85.7% (75.0–92.3) | 95.1% (86.5–98.3) | 94.7% (85.6–98.2) | 86.6% (76.4–92.8) | 90.3% (83.8–94.4) | 116.0 (29.83–451.15) | 0.8 |
| SIEMENS® | 49/63 | 59/61 | 77.8% (66.1–86.3) | 96.7% (88.8–99.1) | 96.1% (86.8–98.9) | 80.8% (70.3–88.2) | 87.1% (80.1–91.9) | 103.25 (22.37–476.49) | 0.7 |
| ROCHE® | 50/63 | 59/61 | 79.4% (67.8–87.5) | 96.7% (88.8–99.1) | 96.2% (87.0–98.9) | 81.9% (71.5–89.1) | 87.9% (81.0–92.5) | 113.46 (24.43–526.96) | 0.8 |
| WONDFO® | 46/63 | 59/61 | 73.0% (61.0–82.4) | 96.7% (88.8–99.1) | 95.8% (86.0–98.8) | 77.6% (67.1–85.5) | 84.7% (77.3–90.0) | 79.82 (17.54–363.17) | 0.7 |
a
Calculated as positive sera among total positive samples and negative sera among total negative samples.
PPV (positive predictive value) and NPV (negative predictive value).