TABLE 2.
Diagnostic accuracy of various serological immunoassays for the presence of previous COVID‐19. Results of a diagnostic accuracy study are shown
| Analytical technique | ELISA | ELISA | ELISA | ECLIA | CLIA | CLIA | LFI |
|---|---|---|---|---|---|---|---|
| Epitope | Anti‐RBD | Anti‐S1 | Anti‐N | Anti‐N | Anti‐N | Anti‐S1/S2 | Anti‐RBD+ |
| Antibody subtype | IgG | IgG | IgG | Pan‐Ig | IgG | IgG | Pan‐Ig |
| Manufacturer | In‐house | Euroimmun | Epitope diagnostics | Roche diagnostics | Abbott | DiaSorin | Bühlmann |
| Numbers of patients | 3637 | 3658 | 3654 | 3630 | 3630 | 3630 | 2589 |
| True positives | 152 | 168 | 126 | 164 | 153 | 160 | 110 |
| False negatives | 40 | 27 | 66 | 25 | 36 | 29 | 21 |
| False positives | 98 | 62 | 79 | 54 | 60 | 84 | 95 |
| True negatives | 3347 | 3401 | 3383 | 3387 | 3381 | 3357 | 2363 |
| AUC (95% CI) | 0.95 (0.93, 0.97) | 0.97 (0.95, 0.98) | 0.90 (0.86, 0.93) | 0.94 (0.91, 0.97) | 0.95 (0.93, 0.98) | 0.95 (0.92, 0.97) | 0.92 (0.88, 0.95) |
| Sensitivity (percent; 95%CI) | 79.2 (72.7, 84.7) | 86.2 (80.5, 90.7) | 65.6 (58.4, 72.3) | 86.8 (81.1, 91.3) | 81.0 (74.6, 86.3) | 84.7 (78.7, 89.5) | 84.0 (76.6, 89.8) |
| Specificity (percent; 95%CI) | 97.2 (96.5, 97.7) | 98.2 (97.7, 98.6) | 97.7 (97.2, 98.2) | 98.4 (98.0, 98.8) | 98.3 (97.8, 98.7) | 97.6 (97.0, 98.1) | 96.1 (95.3, 96.9) |
| Positive likelihood ratio | 28 | 48 | 29 | 55 | 46 | 35 | 22 |
| Negative likelihood ratio | 0.21 | 0.41 | 0.35 | 0.13 | 0.19 | 0.16 | 0.17 |
Consecutive inpatients and medical personnel with suspected COVID‐19 were included in a prospective cross‐sectional study in a real‐life clinical setting (n = 3658). A positive RT‐PCR from a nasopharyngeal swab was defined as the primary reference standard test representing a “previous SARS‐CoV‐2” infection (COVID‐19). Abbreviations: ELISA, enzyme‐linked immunosorbent assay; ECLIA, electrochemiluminescence immunoassay; CLIA, chemiluminescence immunoassay; LFI, lateral flow immunoassay; N, nucleoprotein; RBD, receptor‐binding domain of the SARS‐CoV‐2 spike glycoprotein; S1/2, domain 1 or 2 of the SARS‐CoV‐2 spike glycoprotein; RBD+, extended receptor‐binding domain of the SARS‐CoV‐2 spike glycoprotein.