Table 3.
Validation study results for SARS CoV-2 CLIA assays.
| DiaSorin IgG | OrthoIgG | OrthoT | SiemensT | Abbott IgG | RocheT | ||
|---|---|---|---|---|---|---|---|
| Sensitivity % (95% CI) | 0–14 days post-onset (n = 10) |
60 (31.3–53.2) | 100 (72.3-100) | 100 (72.-100) | 90 (59.6-98.2) | 90 (59.6-98.2) | 90 (59.6-98.2) |
| >14 days post-onset (n = 32) |
80 (61.4–92.3) | 93.3 (77.9–99.2) | 100 (88.4-100) | 86.7 (69.3-96.2) | 96.7 (82.8-99.9) | 93.3 (77.9-99.2) | |
| Overall (n = 42) | 78.6 (64.1–88.3) | 97.6 (87.7–99.6) | 100 (91.5–100) | 90.5 (77.9–96.2) | 95.2 (84.2–98.7) | 92.9 (81.0–97.5) | |
| Specificity % (95% CI) | Presumed negative n = 65 | 95.4 (87.3–98.4) | 98.5 (91.8–99.7) | 98.5 (91.8–99.7) | 100 (94.4–100) | 100 (94.4–100) | 100 (94.4–100) |
| McNemar's p value for overall sensitivity and specificity | Ortho IgG | 0.146 | |||||
| Ortho T | 0.092 | 1.0 | |||||
| Siemens T | 0.727 | 0.125 | 0.063 | ||||
| Abbott IgG | 0.388 | 0.25 | 0.25 | 0.625 | |||
| Roche T | 0.549 | 0.125 | 1.0 | 1.0 | 1.0 | ||
| Estimated PPV%/NPV%* | 1% prevalence | 14.7/99.8 | 39.7/100 | 40.2/100 | 100/99.9 | 100/99.9 | 100/99.9 |
| 5% prevalence | 47.3/97.6 | 77.4/99.9 | 77.8/100 | 100/99.5 | 100/99.7 | 100/99.6 | |
| 10% prevalence | 75.5/97.6 | 87.8/99.7 | 88.1/100 | 100/99.0 | 100/99.5 | 100/99.2 |
Abbreviations: CI=confidence interval; PPV= positive predictive value; NPV=negative predictive value
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PPV/NPV calculations are based on cumulative performance at all time points.