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Table. 1.

Table. 1.

Characteristics and sensitivity and specificity of the five SARS-CoV-2 antibody assays evaluated in this study

Roche (Roche Diagnostics, Mannheim, Germany) Abbott (Abbot Laboratories, Abbott Park, IL, USA) Siemens (Siemens, Munich, Germany) SD Biosensor (SD Biosensor, Suwon, Korea) LG Chem (LG Chem, Seoul, Korea)
Characteristics of the assays
Product name Elecsys anti-SARS-CoV-2 SARS-CoV-2 IgG SARS-CoV-2 total (COV2T) STANDARD E COVID-19 Total Ab AdvanSure SARS-CoV-2 IgG (S1)
Analyzer Elecsys Cobas e801 Architect i2000SR Atellica IM ELISA ELISA
Principle ECLIA CMIA CLIA ELISA ELISA
Target antibody Total (IgG+IgM) IgG Total (IgG+IgM) Total (IgG+IgM) IgG
Used reagent antigen Nucleoprotein Nucleoprotein RBD Spike+Nucleoprotein S1
Sample type Serum, plasma Serum, plasma Serum, plasma Serum, plasma Serum, plasma
Sample volume 20 µL 25 µL 50 µL 50 µL 10 µL
Cut-off value (unit) 1.0 (COI) 1.4 (index) 1.0 (index) NC+0.3 (OD) 1.0 (S/CO)
Time to first result (min) 18 29 15 150 150
Sensitivity and specificity of the assays according to days after symptom onset (or admission)
1–7 (N = 13) 15.4% (2/13) 15.4% (2/13) 15.4% (2/13) 53.8% (7/13) 46.2% (6/13)
8–14 (N = 65) 86.2% (56/65) 86.2% (56/65) 95.4% (62/65) 98.5% (64/65) 92.3% (61/65)
15–21 (N = 84) 98.8% (83/84) 98.8% (83/84) 98.8% (83/84) 100% (84/84) 100% (84/84)
22–28 (N = 43) 100% (43/43) 100% (43/43) 100% (43/43) 100% (43/43) 100% (43/43)
> 28 (N = 97) 96.9% (93/96) 94.8% (92/97) 98.9% (95/96) 98.9% (95/96) 98.9% (95/96)
Unknown (N = 96) 97.9% (94/96) 93.8% (90/96) 97.9% (94/96) 100% (96/96) 100% (96/96)
Total sensitivity (N = 398) 93.5% (371/397, 95% CI 90.6–95.7) 92.2% (367/398, 95% CI 90.0–95.3) 95.7% (380/397, 95% CI 93.2–97.5) 98.0% (389/397, 95% CI 96.1–99.1) 97.0% (385/397, 95% CI 94.5–98.2)
Total specificity
Pre-pandemic controls (N = 510) 99.6% (508/510) 99.2% (506/510) 100% (510/510) 99.6% (508/510) 97.2% (496/510)
Including cross-reactivity and interference (N = 683) 99.7% (681/683, 95% CI 98.9–100) 99.4% (679/683, 95% CI 98.5–99.8) 100% (683/683, 95% CI 99.5–100) 99.3% (678/683, 95% CI 98.3–99.8) 97.5% (666/683, 95% CI 95.9–98.4)

Abbreviations: CMIA, chemiluminescence microparticle immunoassay; CLIA, chemiluminescence immunoassay; CI, confidence interval; COI, cutoff index; ECLIA, electrochemiluminescence immunoassay; ELISA, enzyme-linked immunosorbent assay; NC, negative control; OD, optical density; RBD, receptor-binding domain; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.

Ann Lab Med 2022;42:71~78

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