Table 1.
Diagnostic performance for each described assay using the 117 serum specimens from the validation panel.
| Presumed Positive (n = 31) | Presumed Negative (n = 86) | |||||||
|---|---|---|---|---|---|---|---|---|
| Assay Target | Positive | Negative | Sensitivity% (95% CI) | Positive | Negative | Specificity% (95% CI) | PPV% (95% CI) | NPV% (95% CI) |
| MSD RBD | 31 | 0 | 100 (89.0–100) | 5 | 81 | 94.2 (87.1–97.5) | 86.1 (71.3–93.9) | 100 (95.7–100) |
| MSD Spike | 31 | 0 | 100 (89.0–100) | 0 | 86 | 100 (95.7–100) | 100 (89.0–100) | 100 (95.7–100) |
| MSD NC | 31 | 0 | 100 (89.0–100) | 1 | 85 | 98.8 (93.7–99.8) | 96.9 (84.3–100) | 100 (95.7–100) |
| Siemens Ta | 31 | 0 | 100 (89.0–100) | 0 | 86 | 100 (95.7–100) | 100 (89.0–100) | 100 (95.7–100) |
| Abbott IgGb | 31 | 0 | 100 (89.0–100) | 0 | 86 | 100 (95.7–100) | 100 (89.0–100) | 100 (95.7–100) |
| Ortho Tc | 31 | 0 | 100 (89.0–100) | 2 | 84 | 97.7 (91.9–99.4) | 93.9 (80.4–98.3) | 100 (95.7–100) |
a
ADVIA Centaur XP SARS-CoV-2 Total Antibody (Siemens, USA); target epitope: recombinant RBD of Spike protein.
b
ARCHITECT SARS-CoV-2 IgG (Abbott IgG; Abbott, USA); target epitope: recombinant NC protein.
c
VITROS Anti-SARS-CoV-2 Total Antibody (Ortho Clinical Diagnostics, USA); target epitope: recombinant S1 of Spike protein.