Table 3.
Commercial serological diagnosis of SARS-CoV-2 infection.
| Brand (company) | Company (Country) | Methods | Antibodies detected | Specimens | Sensitivity/specificity | TAT/per test | Approval | Reference |
|---|---|---|---|---|---|---|---|---|
| 2019-nCoV IgG/IgM Rapid Test Cassette (ALLTEST) | Hangzhou ALLTEST Biotech Co., Ltd. (China) | LFIA | IgM and IgG | Whole blood, serum, plasma | IgM: 85%/96% IgG: 100%/98% |
10–20 min | CE-IVD | 48 |
| Wondfo SARS-CoV-2 Antibody Test | Guangzhou Wondfo Biotech Co., Ltd, (China) | LFIA | IgM/IgG | Whole blood, serum, plasma | IgM/IgG: 86.43%/99.57% |
15 min | China FDA-EUA | 47 |
| ASK COVID-19 IgG/IgM Rapid Test | TONYAR Biotech Inc. (Taiwan) | LFIA | IgM and IgG | Whole blood, serum or plasma | 1–14 days after symptom onset: 47.8%/100% 15–21 days: 87.0%/100.0% >day 21 days: 100%/100% | 10 min | No | 50 |
| COVID-19 IgG/IgM Rapid Test Cassette | Zhejiang Oriental Gene Biotech Co. Ltd. (China) | LFIA | IgM and IgG | Whole blood, serum, plasma | IgM: 87.9%/100% IgG: 97.2%/100% | 10 min | CE-IVD | 51 |
| 2019-nCoV Ab Test Cassette (Colloidal Gold) | INNOVITA (Tangshan) Biological Technology Co., Ltd. (China) | LFIA | IgM/IgG | Whole blood, serum, plasma | NA | 15 min | China FDA-EUA CE-IVD |
53 |
| 2019 nCOV IgG/IgM Rapid Test | Dynamiker Biotechnology (Tianjin) Co., Ltd. (China) | LFIA | IgM and IgG | Whole blood, serum, plasma | Mixed (IgM and/or IgG): 93.2%/95.3% | 10 min | CE-IVD | 54 |
| qSARS-CoV-2 IgG/IgM Rapid Test | Cellex Inc. (NC, USA) | LFIA | IgM and IgG | Whole blood, serum, plasma | Mixed (IgM and/or IgG): 93.8%/96.4% | 15–20 min | US FDA- EUA CE-IVD |
55 |
| Anti-SARS-CoV-2 ELISA | EUROIMMUN AG (Lübeck, Germany) | EIA | IgA and IgG | Serum | IgG Sensitivity: <10/>10 days after symptom onset: 33%/100% Specificity: 98.5% IgA Sensitivity: <10/>10 days after symptom onset: 50%/100% Specificity: 92.5% IgG and IgA combined Sensitivity: <10/>10 days after symptom onset: 66.7%/100% |
2–3 h/96 samples | CE-IVD | 56 |
| SARS-CoV-2 IgG | Abbott Laboratories, IL, USA | CMIA | IgG | Serum or plasma | Sensitivity: 3–7 days after symptom onset: 25.0% 8–13 days: 86.1% ≥14 days: 100% Specificity: 99.6%–100% |
NA | CE-IVD, USFDA | 58 |
| Elecsys Anti-SARS-CoV-2 | Roche Diagnostics Basel, Switzerland | ECLIA | Total antibody (including IgG) | Serum or plasma | Sensitivity: 0–6 days after symptom onset: 65.5% 7–13 days: 88.1% ≥14 days: 100%/Specificity: 99.8% |
18 min | CE-IVD, USFDA | 59 |
CE-IVD, Conformité Européenne in vitro diagnostic device; CMIA, chemiluminescent microparticle immunoassay; ECLIA, electrochemiluminescence immunoassay; EIA, enzyme immunoassay; EUA, Emergency Use Authorization; LFIA, lateral flow immunoassay; NA, not available; RUO, research use only; TAT, turnaround time; US FDA, Food and Drug Administration of the United States.