Table 4.
Serology tests with EUA from the U.S. FDA
| Name | Company | Source | Target | Accuracy | Method |
|---|---|---|---|---|---|
| Alinity i SARS-CoV-2 IgG | Abbott | IgG | NP |
IgG Sens 0–7 days: 49.3% 8–13 days: 80.4% ≥ 14 days: 98.1%, IgG Spec: 99.6% |
CLIA |
| Architect SARS-CoV-2 IgG | Abbott | IgG | NP |
IgG Sens 0–7 days: 49.3% 8–14 days: 82.6% ≥ 15 days: 98.1%, IgG Spec: 99.6% |
CLIA |
| AdviseDx SARS-CoV-2 IgM (Architect) | Abbott | IgM | S |
IgM Sens 0–7 days: 42.6% 8–14 days: 79% ≥ 15 days: 95%, IgM Spec: 99.6% |
CLIA |
| Babson Diagnostics aC19G1 | Babson Diagnostics, Inc | IgG | S |
IgG Sens 8–14 days: 66.7% ≥ 15 days: 100% IgG Spec: 100% |
CLIA |
| Access SARS-CoV-2 IgG | Beckman Coulter, Inc | IgG | S |
IgG Sens 0–7 days: 75.8% 8–14 days: 95.3% ≥ 15 days: 96.8%, IgG Spec: 99.6% |
CLIA |
| Access SARS-CoV-2 IgM | Beckman Coulter, Inc | IgM | S |
IgM Sens 0–7 days: 54.4% 8–14 days: 91.7% ≥ 15 days: 98.3%, IgM Spec: 99.9% |
CLIA |
| SARS-CoV-2 IgG and IgM Combo Test | BioCheck, Inc | IgM, IgG | S |
IgM Sens 0–7 days: 100% 8–14 days: 93.8% ≥ 15 days: 88.9%, IgM Spec: 97.2% IgG Sens 0–7 days: 100% 8–14 days: 100% ≥ 15 days: 100%, IgG Spec: 100% |
CLIA |
| SARS-CoV-2 IgG Antibody Test Kit | BioCheck, Inc | IgG | S |
IgG Sens 0–7 days: 100% 8–14 days: 100% ≥ 15 days: 100%, IgG Spec: 100% |
CLIA |
| SARS-CoV-2 IgM Antibody Test Kit | BioCheck, Inc | IgM | S |
IgM Sens 0–7 days: 100% 8–14 days: 93.8% ≥ 15 days: 88.9%, IgM Spec: 97.2% |
CLIA |
| LIAISON SARS-CoV-2 IgM Assay | DiaSorin, Inc | IgM | S |
IgM Sens 0–7 days: 64.4% 8–14 days: 90.2% ≥ 15 days: 92.6%, IgM Spec: 99.3% |
CLIA |
| LIAISON SARS-CoV-2 S1/S2 IgG | DiaSorin, Inc | IgG | S |
IgG Sens 0–5 days: 25% 6–14 days: 89.8% ≥ 15 days: 97.55%, IgG Spec: 99.3% |
CLIA |
| LIAISON SARS-CoV-2 TrimericS IgG | DiaSorin, Inc | IgG | S |
IgG Sens 0–7 days: 21.4% 8–14 days: 70.8% ≥ 15 days: 96.9%, IgG Spec: 99.5% |
CLIA |
| DZ-Lite SARS-CoV-2 IgG CLIA Kit | Diazyme Laboratories, Inc | IgG | S, NP |
IgG Sens 0–7 days: 43.5% 8–14 days: 91.7% ≥ 15 days: 100%, IgG Spec: 97.4% |
CLIA |
| DZ-Lite SARS-CoV-2 IgM CLIA Kit | Diazyme Laboratories, Inc | IgM | S, NP |
IgG Sens 0–7 days: 26.1% 8–14 days: 83.8% ≥ 15 days: 94.4%, IgG Spec: 98.3% |
CLIA |
| QUANTA Flash SARS-CoV-2 IgG | Inova Diagnostics, Inc | IgG | S, NP |
IgG Sens 0–7 days: 66.7% 8–14 days: 61.5% ≥ 15 days: 100%, IgG Spec: 99.9% |
CLIA |
| VITROS Anti-SARS-CoV-2 IgG test | Ortho-Clinical Diagnostics, Inc | IgG | S |
IgG Sens 12–15 days: 83.3% ≥ 16 days: 90%, IgG Spec: 100% |
CLIA |
| VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent | Ortho-Clinical Diagnostics, Inc | Pan-Ig | S |
Pan-Ig Sens 0–7 days: 80% ≥ 8 days: 100%, Pan-Ig Spec: 100% |
CLIA |
| Q-Plex SARS-CoV-2 Human IgG (4 Plex) | Quansys Biosciences, Inc | IgG | S |
IgG Sens 0–7 days: 100% 8–14 days: 100% ≥ 15 days: 95.2%, IgG Spec: 99.7% |
CLIA |
| MAGLUMI 2019-nCoV IgM/IgG | Shenzhen New Industries Biomedical Engineering Co., Ltd | IgM, IgG | S, NP |
IgM Sens 0–7 days: 43.8% 8–14 days: 78.3% ≥ 15 days: 77.5%, IgM Spec: 99.6% IgG Sens 0–7 days: 31.3% 8–14 days: 90.6% ≥ 15 days: 100%, IgG Spec: 99.1% |
CLIA |
| ADVIA Centaur SARS-CoV-2 IgG (COV2G) | Siemens Healthcare Diagnostics | IgG | S |
IgG Sens 0–6 days: 53.5% 7–13 days: 93.4% ≥ 14 days: 100%, IgG Spec: 99.9% |
CLIA |
| ADVIA Centaur SARS-CoV-2 Total (COV2T) | Siemens Healthcare Diagnostics | Pan-Ig | S |
IgG Sens 0–6 days: 61.1% 7–13 days: 97.5% ≥ 14 days: 100%, IgG Spec: 99.8% |
CLIA |
| Atellica IM SARS-CoV-2 IgG (COV2G) | Siemens Healthcare Diagnostics | IgG | S |
IgG Sens 0–6 days: 56% 7–13 days: 92.2% ≥ 14 days: 100%, IgG Spec: 99.9% |
CLIA |
| Atellica IM SARS-CoV-2 Total (COV2T) | Siemens Healthcare Diagnostics | Pan-Ig | S |
Pan-Ig Sens 0–6 days: 60.7% 7–13 days: 97.5% ≥ 14 days: 100%, Pan-Ig Spec: 99.8% |
CLIA |
| Vibrant COVID-19 Ab Assay | Vibrant America Clinical Labs | Pan-Ig | S, NP |
IgG/IgM Sens: 98.1%, IgG/IgM Spec: 98.6% |
CLIA |
| WANTAI SARS-CoV-2 Ab ELISA | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd | Pan-Ig | S |
Pan-Ig Sens 0–7 days: 55.4% 8–14 days: 84.8% ≥ 15 days: 98.7%, Pan-Ig Spec: 97.5% |
ELISA |
| Platelia SARS-CoV-2 Total Ab | Bio-Rad Laboratories, Inc | Pan-Ig | NP |
Pan-Ig Sens 0–7 days: 100% 8–14 days: 96% ≥ 15 days: 100%, Pan-Ig Spec: 99.3% |
ELISA |
| SARS-CoV-2 RBD IgG test | Emory Medical Laboratories | IgG | S |
IgG Sens 0–7 days: 73% 8–14 days: 100% ≥ 15 days: 100%, IgG Spec: 97.7% |
ELISA |
| SARS-CoV-2 ELISA (IgG) | EUROIMMUN | IgG | S |
IgG Sens 0–4 days: 21.7% 5–10 days: 69.4% ≥ 11 days: 81.1%, IgG Spec: 100% |
ELISA |
| cPass SARS-CoV-2 Neutralization Antibody Detection Kit | GenScript USA Inc | Pan-Ig | S |
Pan-Ig Sens: 100%, Pan-Ig Spec: 100% |
ELISA |
| SCoV-2 Detect IgG ELISA | InBios International, Inc | IgG | S |
IgG Sens 8–14 days: 100% ≥ 15 days: 95.5%, IgG Spec: 100% |
ELISA |
| SCoV-2 Detect IgM ELISA | InBios International, Inc | IgM | S |
IgM Sens 0–7 days: 66.7% 8–14 days: 91.4% ≥ 15 days: 93.8%, IgM Spec: 98.8% |
ELISA |
| COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit | Kantaro Biosciences, LLC | IgG | S |
IgG Sens 0–7 days: 100% 8–14 days: 100% ≥ 15 days: 93%, IgG Spec: 99.6% |
ELISA |
| Mt. Sinai Laboratory COVID-19 ELISA Antibody Test | Mount Sinai Hospital Clinical Laboratory | IgM, IgG | S |
Combined Sens: 92.5%, Combined Spec: 100% |
ELISA |
| Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test | Quanterix Corporation | IgG | S |
IgG Sens 0–7 days: 45.2% 8–14 days: 87.5% ≥ 15 days: 100%, IgG Spec: 99.2% |
ELISA |
| Dimension Vista SARS-CoV-2 Total Ab assay (COV2T) | Siemens Healthcare Diagnostics | Pan-Ig | S |
Pan-Ig Sens 0–6 days: 66.7% 7–13 days: 97.4% ≥ 14 days: 100%, Pan-Ig Spec: 99.8% |
ELISA |
| Dimension EXL SARS-CoV-2 Total Ab assay (CV2T) | Siemens Healthcare Diagnostics | Pan-Ig | S |
Pan-Ig Sens 0–6 days: 68.8% 7–13 days: 97.4% ≥ 14 days: 100%, Pan-Ig Spec: 99.9% |
ELISA |
| COVID-19 self-collected Ab test system | Symbiotica, Inc | IgG | S |
IgG Sens 8–14 days: 100% ≥ 15 days: 100%, Pan-Ig Spec: 98.04% |
ELISA |
| OmniPATH COVID-19 Total Antibody ELISA Test | Thermo Fisher Scientific | Pan-Ig | S |
Pan-Ig Sens 0–7 days: 19% 8–14 days: 76.7% ≥ 15 days: 100%, Pan-Ig Spec: 100% |
ELISA |
| COVID-19 ELISA pan-Ig Antibody Test | University of Arizona Genetics Core for Clinical Services | Pan-Ig | S |
Pan-Ig Sens ≥ 15 days: 97.5%, Pan-Ig Spec: 99.1% |
ELISA |
| ZEUS ELISA SARS-CoV-2 Total Test | ZEUS Scientific, Inc | Pan-Ig | S |
Pan-Ig Sens: 93.3%, Pan-Ig Spec: 100% |
ELISA |
| ZEUS ELISA SARS-CoV-2 IgG Test System | ZEUS Scientific, Inc | IgG | S |
IgG Sens 0–7 days: 100% 8–14 days: 100% ≥ 15 days: 100%, IgG Spec: 99.1% |
ELISA |
| CareStart COVID-19 IgM/IgG | Access Bio, Inc | IgM, IgG | S, NP |
IgM Sens 8–14 days: 100% ≥ 15 days: 88.7%, IgM Spec: 99.5% IgG Sens 8–14 days: 100% ≥ 15 days: 96.8%, IgG Spec: 99.5% |
LFIA |
| Assure COVID-19 IgG/IgM Rapid Test Device | Assure Tech | IgM, IgG | S, NP |
IgG/IgM Sens 0–7 days: 100% 8–14 days: 83.3% ≥ 15 days: 89.3%, IgG/IgM Spec: 100% |
LFIA |
| ACON SARS-CoV-2 IgG/IgM Rapid Test | ACON Laboratories, Inc | IgM, IgG | S, NP |
IgG/IgM Sens 0–7 days: 100% 8–14 days: 100% ≥ 15 days: 100%, IgG/IgM Spec: 95.9% |
LFIA |
| RapCov Rapid COVID-19 Test | ADVAITE, Inc | IgG | NP |
IgG Sens ≥ 15 days: 93.3%, IgG Spec: 99.5% |
LFIA |
| WANTAI SARS-CoV-2 Ab Rapid Test | Beijing Wantai Biological Pharmacy Enterprise Co., Ltd | Pan-Ig | S |
Pan-Ig Sens: 100%, Pan-Ig Spec: 98.8% |
LFIA |
| Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test | Biocan Diagnostics Inc | IgM, IgG | S, NP |
IgM Sens 8–14 days: 88.9% ≥ 15 days: 85.2%, IgM Spec: 98.7% IgG Sens 8–14 days: 100% ≥ 15 days: 100%, IgG Spec: 96.2% |
LFIA |
| Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit | Biohit Healthcare (Hefei) | IgM, IgG | NP |
IgM Sens 0–7 days: 33.3% 8–14 days: 83% ≥ 15 days: 97.7%, IgM Spec: 99.5% IgG Sens 8–14 days: 56.6% ≥ 15 days: 96.2%, IgG Spec: 100% |
LFIA |
| qSARS-CoV-2 IgG/IgM Rapid Test | Cellex, Inc | IgM, IgG | S, NP |
Combined Sens: 93.8%, Combined Spec: 96% |
LFIA |
| COvAb SARS-CoV-2 Ab Test | Diabetomics, Inc | Pan-Ig | S |
Pan-Ig Sens 0–7 days: 41.6% 8–14 days: 84.2% ≥ 15 days: 97.6%, Pan-Ig Spec: 98.78% |
LFIA |
| RightSign COVID-19 IgG/IgM Rapid Test Cassette | Hangzhou Biotest Biotech | IgM, IgG | S |
IgG/IgM Sens 0–7 days: 66.7% 8–14 days: 100% ≥ 15 days: 88.9%, IgG/IgM Spec: 100% |
LFIA |
| LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo | Hangzhou Laihe Biotech | IgM, IgG | S |
IgM Sens 0–6 days: 100% 7–14 days: 85.7% ≥ 15 days: 99.3%, IgM Spec: 99.4% IgG Sens 7–14 days: 76.2% ≥ 15 days: 98.5%, IgG Spec: 99.4% |
LFIA |
| COVID-19 IgG/IgM Rapid Test Cassette | Healgen Scientific, LLC | IgM, IgG | S |
IgM Sens: 100%, IgM Spec: 100% IgG Sens: 96.7%, IgG Spec: 97.5% Combined Sens: 100%, Combined Spec: 97.5% |
LFIA |
| Innovita 2019-nCoV Ab Test (Colloidal Gold) | Innovita (Tangshan) Biological Technology Co., Ltd | IgM, IgG | S, NP |
IgG/IgM Sens 0–7 days: 87.9% 8–14 days: 96.6% ≥ 15 days: 100%, IgG/IgM Spec: 98% |
LFIA |
| SCoV-2 Detect IgG Rapid Test | InBios International, Inc | IgG | S |
IgG Sens 0–7 days: 92.9% 8–14 days: 81.8% ≥ 15 days: 100%, IgG Spec: 97.7% |
LFIA |
| Orawell IgM/IgG Rapid Test | Jiangsu Well Biotech | IgM, IgG | S |
IgG/IgM Sens 8–14 days: 98.2% ≥ 15 days: 100%, IgG/IgM Spec: 98% |
LFIA |
| Rapid COVID-19 IgM/IgG Combo Test Kit | Megna Health, Inc | IgM, IgG | NP |
IgM Sens 0–7 days: 66.7% 8–14 days: 77.1% ≥ 15 days: 90.9%, IgM Spec: 99.6% IgG Sens 0–7 days: 62.3% 8–14 days: 85.7% ≥ 15 days: 90.9%, IgG Spec: 99.3% |
LFIA |
| Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit | Nirmidas Biotech, Inc | IgM, IgG | S |
IgG Sens 0–7 days: 27.8% 8–14 days: 76.5% ≥ 15 days: 100%, IgM Sens 0–7 days: 27.8% 8–14 days: 82.4% ≥ 15 days: 97%, IgM/IgG Spec: 84.8% |
LFIA |
| ADEXUSDx COVID-19 Test | NOWDiagnostics, Inc | Pan-Ig | S |
Pan-Ig Sens: 93.3%, Pan-Ig Spec: 100% |
LFIA |
| QIAreach Anti-SARS-CoV-2 Total Test | QIAGEN, GmbH | Pan-Ig | S |
Pan-Ig Sens: 100% Pan-Ig Spec: 97.5% |
LFIA |
| Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette | Salofa Oy | IgM, IgG | S |
IgM Sens: 90%, IgM Spec: 100% IgG Sens: 93.3%, IgG Spec: 98.8% Combined Sens: 93.3%, Combined Spec: 98.8% |
LFIA |
| SGTi-flex COVID-19 IgG | Sugentech, Inc | IgG | S, NP |
IgG Sens 0–7 days: 41.2% 8–14 days: 91.7% ≥ 15 days: 98.6%, IgG Spec: 100% |
LFIA |
| TBG SARS-CoV-2 IgG/IgM Rapid Test Kit | TBG Biotechnology Corp | IgM, IgG | S, NP |
IgM/IgG Sens ≥ 15 days: 96.4%, IgM/IgG Spec: 99.8% |
LFIA |
| BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test | Xiamen Biotime Biotechnology Co., Ltd | IgM, IgG | S |
IgM Sens 0–7 days: 55.1% 8–14 days: 94.1% ≥ 15 days: 100%, IgG Sens 0–7 days: 46.4% 8–14 days: 67.7% ≥ 15 days: 100%, IgM/IgG Spec: 98.5% |
LFIA |
| VIDAS SARS-CoV-2 IgG | BioMérieux SA | IgG | S |
IgG Sens 0–7 days: 47.9% 8–14 days: 100% ≥ 15 days: 100%, IgG Spec: 99.9% |
ELFA |
| VIDAS SARS-CoV-2 IgM | BioMérieux SA | IgM | S |
IgM Sens 0–7 days: 53.8% 8–14 days: 100% ≥ 15 days: 100%, IgG Spec: 99.4% |
ELFA |
| Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2 | Genalyte, Inc | Pan-Ig | S, NP |
Ig Sen 0–7 days: 66.7% 8–14 days: 90.9% ≥ 15 days: 96.1%, Ig Spec: 97.7% |
PRI |
| xMAP SARS-CoV-2 Multi-Antigen IgG Assay | Luminex Corporation | IgG | S, NP |
IgG Sens 0–7 days: 71.1% 8–14 days: 71.4% ≥ 15 days: 96.2%, IgG Spec: 100% |
FMIA |
| BioPlex 2200 SARS-CoV-2 IgG | Bio-Rad Laboratories | IgG | S |
IgG Sens 0–7 days: 81.3% 8–14 days: 96.3% ≥ 15 days: 93.9%, IgG Spec: 99.9% |
FIA |
| FREND COVID-19 total Ab | NanoEntek America, Inc | IgM, IgG | NP |
Combined Sens: 96.7%, Combined Spec: 98.8% |
FIA |
| MosaiQ COVID-19 Antibody Magazine | Quotient Suisse SA | Pan-Ig | S |
Ig Sens 0–7 days: 100% 8–14 days: 100% ≥ 15 days: 93%, Ig Spec: 99.8% |
PIA |
| Elecsys Anti-SARS-CoV-2 | Roche Diagnostics, Inc | Pan-Ig | NP |
Ig Sens 0–6 days: 60.2% 7–13 days: 85.3% ≥ 14 days: 99.5%, Ig Spec.: 99.7% |
ECLIA |
| Elecsys Anti-SARS-CoV-2 S | Roche Diagnostics, Inc | Pan-Ig | S |
Ig Sens 0–7 days: 90.6% 8–14 days: 87% ≥ 15 days: 96.6%, Ig Spec.: 100% |
ECLIA |
| New York SARS-CoV Microsphere Immunoassay for Antibody | Wadsworth Center, New York State Department of Health | Pan-Ig | NP |
Ig Sens 0–6 days: 17.9% 7–10 days: 31.3% 11–15 days: 48.9% 16–20 days: 49.2% > 20 days: 79.3%, Ig Spec: 99.6% |
MIA |
CLIA chemiluminescence immunoassay, ECLIA enzyme-enhanced chemiluminescence immunoassay, ELFA enzyme-linked fluorescence assay, FMIA fluorescent microsphere immunoassay, FIA fluorescence immunoassay, LFIA lateral flow immunoassay, MIA: magnetic immunoassay, NP nucleoprotein, PIA photometric immunoassay, PRI photonic ring immunoassay, S spike protein, Sens sensitivity (positive percent agreement), Spec specificity (negative percent agreement). The commercial kits granted EUA are updated based on the FDA. For each type of method, the products are listed in alphabetical order of the company names