TABLE 3.
Summary of antigen–antibody‐based serology tests for SARS‐CoV‐2(EUAs)
| Detection target | Collected samples | Clinical Performance | Manufacturer | Detection principle | Diagnostic | Source |
|---|---|---|---|---|---|---|
| IgM and IgG | Plasma, serum |
PPA (≤6 days, 7–14 days, >14 Days, Days from Symptoms Onset to Blood Collection): IgM: 100%, 85.71%, 99.25%; IgG: 0.00%, 76.19%, 98.50%; NPA: IgM/IgG: 99.43% |
Hangzhou Laihe Biotech Co., Ltd. | Lateral Flow (Colloidal Gold) | LYHER Novel Coronavirus (2019‐nCoV) IgM/IgG Antibody Combo Test Kit | 146 |
| Human venous/fingerstick whole blood, serum, plasma |
PPA (0–7 days, 8–14 days, ≥15 days): (1) Serum: IgM: 100%, 86.7%, 84%; IgG: 87.5%, 86.7%, 100% (2) Whole Blood: IgM: 100%, 100%, 100%; IgG: 100%,100%,100%; NPA: 99.04% |
Assure Tech. (Hangzhou Co., Ltd) | Lateral Flow (Colloidal Gold) | Assure COVID‐19 IgG/IgM Rapid Test Device | 147 | |
| Human venous whole blood, plasma or serum |
Either IgG+ or IgM+: PPA: 96.7% (95% CI: 90.7–98.9%) NPA: 97.0% (95% CI: 91.6–99.0%) |
Healgen Scientific LLC | Lateral Flow (Colloidal Gold) | COVID‐19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) | 148 | |
| Human serum and serum |
Total IgM and IgG Combined PPA: 93.94% (≤ 7: 43.75%, 8–14: 93.40%, ≥15: 100%, Days post symptom onset) NPA: 98.67% |
Shenzhen New Industries Biomedical Engineering Co., Ltd. | CLIA | MAGLUMI 2019‐nCoV IgM/IgG | 149 | |
| Human serum, acid citrate dextrose (ACD) plasma, fingerstick whole blood |
PPA(0–7, 8–14, ≥ 15, Days of Symptoms Onset): IgM:76.9%, IgG:75.9% NPA: IgM:99.6%, IgG:99.3% |
Megna Health, Inc. | Lateral Flow | Rapid COVID‐19 IgM/IgG Combo Test Kit | 150 | |
| Human serum and acid citrate dextrose (ACD) plasma |
Overall PPA: 97.14% NPA: 100% |
Jiangsu Well Biotech Co., Ltd. | Lateral Flow | Orawell IgM/IgG Rapid Test | 151 | |
| Human serum, plasma, venous whole blood |
PPA(0–7, 8–14, ≥15, Days from Symptom Onset): (1) IgG: 0%, 56.6%, 96.21% (2) IgM: 33.33%, 83.02%, 97.73% NPA: IgM:99.46%, IgG:100% |
Biohit Healthcare (Hefei) Co. Ltd. | Lateral Flow | Biohit SARS‐CoV‐2 IgM/IgG Antibody Test Kit | 152 | |
| Total Neutralizing Antibodies | Human serum and plasma |
Total PPA: 96.0% (<7: NA, 8–14: 85.7%, >15: 97.7%, Days Between Onset of Symptoms and Specimen Draw) NPA: 98. 9% |
ZEUS Scientific, Inc. | Indirect ELISA | ZEUS ELISA SARS‐CoV‐2 Total Antibody Test System | 153 |
| Human serum and plasma |
PPA: 96.2% (87.3–99.0%) NPA: 96.3% (89.8–98.8%) |
InBios International, Inc. | Qualitative competitive inhibition ELISA | SCoV‐2 Detect Neutralizing Ab ELISA | 154 | |
| Human venous/fingerstick whole blood, plasma, serum |
Serum and Plasma Samples: PPA (≤7, 8–14, ≥15, Days post‐RT‐PCR test): 94.9%, 96.0%, 100% NPA: 97.9% |
NOWDiagnostics, Inc. | Lateral Flow (Colloidal Gold) | ADEXUSDx COVID‐19 test | 155 | |
| Human serum and plasma |
LoB: 0.30 U/ml, LoD: 0.35 U/ml LoQ: 0.40 U/ml, PPA (0–7, 8–14, ≥ 15, Days after PCR positive result): 90.6%, 87.0%, 96.6%, NPA: 99.98% |
Roche Diagnostics, Inc. | ECLIA | Elecsys anti‐SARS‐CoV‐2S | 156 | |
| Human serum and plasma |
Overall PPA: 93.85% (0–7: 66.67%, 8–14: 92.31%, > 15: 95.92%, Number of days after symptom onset) NPA:97.83% |
QIAGEN, GmbH | Digital lateral flow | QIAreach anti‐SARS‐CoV‐2 total test | 157 | |
| Human serum and plasma |
Serum: PPA:98.86%; NPA:100% Plasma: PPA:100%; NPA: 95.6% |
Bio‐Rad Laboratories, Inc. | ELISA | Platelia SARS‐CoV‐2 total Ab assay | 158 | |
| IgG | Human serum | LoB: 0.029 μg/ml, LoD: 0.051 μg/ml, LoQ: 0.213 μg/ml, PPA (0–7, 8–14, ≥ 15, Days from positive PCR test): 45.16%, 87.50%, 100.00%, NPA: 99.19% | Quanterix Corporation | Paramagnetic microbead‐based sandwich ELISA | Simoa semi‐quantitative SARS‐CoV‐2 IgG antibody test | 159 |
| Human serum, plasma |
Total PPA: 92.7%(≤7: 75.8%, 8–14: 95.3%, ≥15: 96.8%, >18: 100%, Days between positive PCR and Sample Collection) NPA: 99.6% |
Beckman Coulter, Inc. | CLIA | Access SARS‐CoV‐2 IgG | 160 | |
| Human serum |
PPA(0–7, 8–14, ≥15, Days from positive PCR): 73.01%, 100%, 100% NPA (Two clinical studies): 97.68% (379/388), 94.4% (236/250) |
Emory Medical Laboratories | ELISA | SARS‐CoV‐2 RBD IgG test | 161 | |
| Serum and plasma |
PPA (0–7, 8–14, ≥15): (1) Days post‐symptom onset: 49.33%, 82.61%, 98.11% (2) Days post‐positive PCR: 56.07%, 95.77%, 97.56% NPA:99.55% |
Abbott Laboratories Inc. | CMIA | AdviseDx SARS‐CoV‐2 IgG II | 162 | |
| Human serum and plasma |
PPA(0–7, 8–14, ≥15, Days Post Agreement Symptom Onset): 61.9%, 92.9%, 100% NPA: 100% |
Siemens Healthcare Diagnostics Inc. | CLIA | Dimension EXL SARS‐CoV‐2 IgG (CV2G) | 163 | |
| Human serum or plasma |
PPA (≥15, Days post PCR confirmation): 93.3% NPA:99.2% |
EUROIMMUN US, Inc. | ELISA | EUROIMMUN Anti‐SARS‐CoV‐2S1 Curve ELISA (IgG) | 164 | |
| IgM | human serum and plasma |
PPA (0–7, 8–14, ≥15, Days from Symptom Onset): 26.1%, 83.3%, 94.4% NPA:98.3% |
Diazyme Laboratories, Inc. | CLIA | Diazyme DZ‐Lite SARS‐CoV‐2 IgM CLIA Kit | 165 |
Abbreviations: LoB, limit of blank; LoD, limit of detection; LoQ, limit of quantitation; NPA, negative percent agreement, specificity; PPA, positive percent agreement, sensitivity.