Table 2. Examples of Serological and Immunological Tests Used to Detect Viral Protein or Antibodies to SARS-CoV-2 Virus.
| test name | test type | manufacturer/organization name | sample source | Ig or protein detected | test result time/additional information | EUAa | country of approval |
|---|---|---|---|---|---|---|---|
| m2000 SARS-CoV-2 assay | chemiluminescent microparticle immunoassay | Abbott Core Laboratory | serum/plasma/whole blood | IgG | runs up to 100–200 tests/h | United States | |
| COVID-19 IgG/IgM LF | lateral flow immunoassay | Advagen Biotech | serum/plasma/whole blood | IgG/IgM | results in 10 min | Brazil | |
| COVID-19 IgG/IgM Point of Care Rapid test | lateral flow immunoassay | Aytu Biosciences/Orient Gene Biotech | serum/plasma/whole blood | IgG/IgM | results in 2–10 min | China, United States | |
| COVID-19 IgM/IgG rapid test | lateral flow immunoassay | BioMedomics | serum/plasma/whole blood | IgG/IgM | results in 15 min | United States | |
| IgG antibody test kit for novel coronavirus 2019-nCoV | magnetic particle-based chemiluminescence immunoassay | Bioscience (Chongqing) Diagnostic Technology Co., Ltd. | serum | IgG | NMPA | China | |
| One-Step COVID-2019 test | lateral flow immunoassay | Celer Biotechnologia | serum/plasma/whole blood | IgG/IgM | results in 15 min | Brazil | |
| qSARS-CoV-2 IgG/IgM rapid test | lateral flow immunoassay | Cellex Inc. | serum/plasma/whole blood | IgG/IgM | results in 15–20 min, antibodies specific for N protein | Australia 3/31/2020, US FDA 4/01/2020 | Australia, United States |
| COVID-19 Ag Respi-Strip | lateral flow immunoassay (dipstick) | Coris Bioconcept | nasal mucus swabs | viral antigen | results in 15 min | Belgium | |
| DPP COVID-19 IgM/IgG system | lateral flow immunoassay | Chembio Diagnostics | serum/plasma/whole blood | IgG/IgM | results in 15 min | US FDA 4/14/2020 | Brazil |
| DEIASL019/020 SARS-CoV-2 IgG ELISA kit | ELISA | Creative Diagnostics | serum/plasma | IgG/IgM | IgG specific for N protein | United States | |
| OnSite COVID-19 IgG/IgM rapid test | lateral flow immunoassay | CTK Biotech Inc. (USA) | serum/plasma/whole blood | IgG/IgM | results in 10 min | Australia | |
| Diazyme DZ-Lite SARS-CoV-2 IgG/IgM test | luminescent immunoassay | Diazyme Laboratories | blood sample | IgG/IgM | EUA not required | United States | |
| KT-1033 EDI Novel Coronavirus COVID-19 ELISA kit | ELISA | Epitope Diagnostics | serum | IgG/IgM | United States | ||
| VivaDiag COVID-19 IgM/IgG rapid test | lateral flow immunoassay | Everest Links Pte Ltd. | serum/plasma/whole blood | IgG/IgM | results in 15 min | Singapore | |
| COVID-19 IgG/IgM rapid test cassette | lateral flow immunoassay | Hangzhou Biotest Biotech Co. Ltd. | serum/whole blood | IgG/IgM | results in 15–20 min | Australia 4/4/2020 | Australia |
| VITROS-Immunodiagnostics Products Anti-SARS-CoV-2 total reagent pack | ELISA | Ortho-Clinical Diagnostics | blood serum/plasma | IgG/IgM | cannot distinguish between IgG/IgM | US FDA 4/14/2020 | United States |
| SARS-CoV-2 rapid test | lateral flow immunoassay | PharmACT | whole blood/serum | IgG/IgM | results in 20 min, N protein, S1 and S2 subunits used as antigens | Germany | |
| Standard Q COVID-19 IgM/IgG Duo | lateral flow immunoassay | SD Biosensor | serum/plasma/whole blood | IgG/IgM | results in 10 min | EUA not required | South Korea |
| Standard Q COVID-19 Ag | chromatographic immunoassay | SD Biosensor | nasopharyngeal swabs | viral antigen | results in 30 min | South Korea | |
| iFLASH-SARS-CoV-2-IgG/IgM | immunoassay | Shenzhen Yhlo Biotech Company | serum/plasma/whole blood | IgG/IgM | China | ||
| MAGLUMI IgG/IgM de 2019-nCoV (CLIA) | chemiluminescence immunoassay | Snibe Diagnostic (China) | blood serum/plasma | IgG/IgM | results in 30 min | CE mark 2/2020 | Brazil |
a
Emergency Use Authorization by US FDA or other drug regulatory authorities.