Table 1.
Performances of ELISAs/ECLIA for SARS-CoV-2 antibody detection
| Early samples | Late samples | |||||||
|---|---|---|---|---|---|---|---|---|
| Sensitivity overall in % (95% CI) (n=15) | Sensitivity ICU in % (95% CI) (n=10) | Sensitivity HCW in % (95% CI) (n=5) | Sensitivity overall in % (95% CI) (n=25) | Sensitivity ICU in % (95% CI) (n=16) | Sensitivity HCW in % (95% CI) (n=9) | Specificity in % (95% CI) (n = 22) | AUC (95% CI) | |
| ELISA | ||||||||
| Epitope Diagnostics IgG | 33.3 (13.5–58.5) | 40.0 (14.6–70.0) | 20.0 (1.3–62.8) | 88.0 (71.8–96.9) | 100 | 66.7 (34.5–90.5) | 95.5 (81.5–99.7) | 0.97 (0.93–1.00) |
| Epitope Diagnostics IgM | 26.7 (9.2–51.5)–33.3 (13.5–58.5)a | 30.0 (8.5–60.7)–40.0 (14.6–70.0)a | 20.0 (1.3–62.8) | 64.0 (44.5–80.8)–80.0 (61.8–92.3)a | 87.5 (66.2–97.8)–93.8 (75.3–99.6)a | 22.2 (4.1–54.2)–55.6 (24.9–83.5)a | 100 | 0.95 (0.89–1.00) |
| Euroimmun IgG | 6.7 (0.4–26.2)–13.3 (2.3–35.8)a | 10.0 (0.6–37.2)–20.0 (3.6–49.9)a | 0 | 92.0 (77.3–98.6) | 100 | 77.8 (45.8–95.9) | 100 | 0.97 (0.91–1.00) |
| Euroimmun IgA | 46.7 (23.5–70.9)–53.3(29.1–76.5)a | 60.0 (30.0–85.4) | 20.0 (1.3–62.8)–40.0 (8.1–80.1)a | 92.0 (77.3–98.6) | 100 | 77.8 (45.8–95.9) | 100 | 0.97 (0.91–1.00) |
| Mikrogen Diagnostik IgG | 26.7 (9.2–51.5) | 30.0 (8.5–60.7) | 20.0 (1.3–62.8) | 88.0 (71.8–96.9)–92.0 (77.3–98.6)a | 100 | 66.7 (34.5–90.5)–77.8 (45.8–95.9)a | 95.5 (81.5–99.7) | 0.95 (0.88–1.00) |
| Vircell IgG | 46.7 (23.5–70.9)–60.0(35.1–81.7)a | 60.0 (30.0–85.4)–70.0 (39.3–91.5)a | 20.0 (1.3–62.8)–40.0 (8.1–80.1)a | 96.0 (83.5–99.8) | 100 | 88.9 (59.5-99.3) | 95.5 (81.5–99.7) | 0.99 (0.96–1.00) |
| Vircell IgM + IgA | 40.0 (18.3–64.9) | 50.0 (21.8–78.2) | 20.0 (1.3–62.8) | 88.0 (71.8–96.9)–96.0 (83.5–99.8)a | 100 | 66.7 (34.5–90.5)–88.9 (59.5–99.3)a | 68.2 (47.5–84.9)–77.3 (57.4–91.2)a | 0.92 (0.84–1.00) |
| Wantai Ig | 53.3 (29.1–76.5) | 60.0 (30.0–85.4) | 40.0 (8.1–80.1) | 96.0 (83.5–99.8) | 100 | 88.9 (59.5–99.3) | 95.5 (81.5-99.7) | 0.98 (0.94–1.00) |
| Wantai IgM | 40.0 (18.3–64.9) | 50.0 (21.8–78.2) | 20.0 (1.3–62.8) | 88.0 (71.8–96.9) | 100 | 66.7 (34.5–90.5) | 100 | 0.96 (0.89–1.00) |
| ECLIA | ||||||||
| Roche Ig | 33.3 (13.5–58.5) | 40.0 (14.6–70.0) | 20.0 (1.3–62.8) | 88.0 (71.8–96.9) | 100 | 66.7 (34.5–90.5) | 100 | 0.99 (0.96–1.00) |
AUC area under (ROC) curve, ELISA enzyme-linked immunosorbent assay, ECLIA electrochemiluminescence immunoassay, Ig immunoglobulin, ICU intensive care unit, HCW healthcare worker
Sensitivity, specificity and AUC for all ELISAs/ECLIA tested, using 25 late sera and 15 early sera of patients with a positive PCR for SARS-CoV-2 and 22 negative controls. 95% CI are shown in parentheses. The early samples include the samples 6 to 8 days after start of disease, whereas the late samples include the samples >14 days after start of disease
aTwo calculations were used for borderline results: the first one with borderline values counted as negative and the second with borderline values counted as positive