TABLE 3.
Diagnostic accuracy of serological immunoassays for the presence of neutralizing antibodies
| 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 | 197 | 201 | 197 | 188 | 188 | 188 | 157 |
| True positives | 127 | 140 | 98 | 133 | 122 | 131 | 95 |
| False negatives | 21 | 11 | 50 | 12 | 23 | 14 | 13 |
| False positives | 2 | 4 | 17 | 3 | 0 | 1 | 1 |
| True negatives | 47 | 46 | 32 | 40 | 43 | 42 | 48 |
| Sensitivity (percent; 95%CI) | 85.8 (91.0, 79.1) | 92.7 (87.3, 96.3) | 66.2 (58.0, 73.8) | 91.7 (86.0, 95.6) | 84.1 (77.2, 89.7) | 90.3 (84.3, 94.6) | 87.9 (80.3, 93.4) |
| Specificity (percent; 95%CI) | 95.9 (86.0, 99.5) | 92.0 (80.8, 97.8) | 65.3 (50.4, 78.3) | 93.0 (80.9, 98.5) | 100 (91.8, 100) | 97.7 (87.7, 99.9) | 97.9 (89.2, 100) |
A subset of complex patients was selected for analysis using the live SARS‐CoV‐2 neutralization assay because of limited resources (n = 201). 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