List of SARS-CoV-2 antigen and antibody test kits approved by Ministry of Food and Drug Safety (as of September 28, 2021)
| Manufacturer | Kit | Approval date | Method | |
|---|---|---|---|---|
| 1 | SD Biosensor | STANDARDTM Q COVID-19 IgM/IgG Plus Test | ‘20.11.6. | Rapid Antibody |
| 2 | Sugenetech | SGTi-flex COVID-19 IgM/IgG | ‘20.12.18. | Rapid Antibody |
| 3 | SD Biosensor | STANDARDTM F COVID-19 IgM/IgG Combo FIA | ‘21.1.26. | Rapid Antibody |
| 4 | Roche | Elecsys Anti-SARS-CoV-2 | ‘21.4.16 | Rapid Antibody |
| 5 | Siemens Healthineers | ADVIA Centaur SARS-CoV-2 Total (COV2T) | ‘21.4.16 | Rapid Antibody |
| 6 | GenBody | GenBody COVID-19 IgM/IgG | ‘21.4.20 | Rapid Antibody |
| 7 | Humasis | Humasis COVID-19 IgG/IgM Test | ‘21.5.6 | Rapid Antibody |
| 8 | SG Medical | R-FIND COVID-19 IgM ELISA | ‘21.5.6 | ELISA Antibody |
| 9 | SG Medical | R-FIND COVID-19 IgG ELISA | ‘21.5.6 | ELISA Antibody |
| 10 | SG Medical | R-FIND COVID-19 IgG/M/A ELISA | ‘21.5.6 | ELISA Antibody |
| 11 | Wells Bio | careUSTM COVID-19 IgM/IgG Ab | ‘21.5.27 | Rapid Antibody |
| 12 | LG Chemical | AdvanSureTM SARS-CoV-2 IgG (S1) ELISA | ‘21.5.27 | ELISA Antibody |
| 13 | PCL | PCL SARS-CoV-2 IgG EIA | ‘21.8.12 | ELISA Antibody |
| 14 | MiCo BioMed | COVID-19 Biokit IgG/IgM | ‘21.8.13 | Rapid Antibody |
| 15 | SD Biosensor | STANDARDTM Q COVID-19 Ag Test | ‘20.11.11. | Rapid Antigen |
| 16 | GenBody | GenBody COVID-19 Ag | ‘20.12.24. | Rapid Antigen |
| 17 | SD Biosensor | STANDARDTM F COVID-19 Ag FIA | ‘21.1.5. | Rapid Antigen |
| 18 | RapiGEN | BIOCREDIT COVID-19 Ag | ‘21.3.18. | Rapid Antigen |
| 19 | Humasis | Humasis COVID-19 Ag Test | ‘21.3.18. | Rapid Antigen |
| 20 | Humasis | Humasis COVID-19 Ag Home Test | ‘21.4.23 | Rapid Antigen |
| 21 | SD Biosensor | STANDARDTM Q COVID-19 Ag Home Test | ‘21.4.23 | Rapid Antigen |
| 22 | Celltrion | DiaTrustTM COVID-19 Ag Home Test | ‘21.5.03 | Rapid Antigen |
| 23 | Sugenetech | SGTi-flex COVID-19 Ag | ‘21.5.25 | Rapid Antigen |
| 24 | RapiGEN | BIOCREDIT COVID-19 Ag Home Test | ’21.7.13. | Rapid Antigen |
| 25 | Boditech Med | ichromaTM COVID-19 Ag | ‘21.7.13 | Rapid Antigen |
| 26 | Boditech Med | AFIAS COVID-19 Ag | ‘21.7.15 | Rapid Antigen |
| 27 | GC MS | GENEDIA W COVID-19 Ag | ‘21.7.29 | Rapid Antigen |
| 28 | Precision Biosensor | PBCheck COVID-19 Ag | ‘21.8.3 | Rapid Antigen |
| 29 | BBB Tech | MARK-BTM COVID-19 Ag | ‘21.8.9 | Rapid Antigen |
| 30 | Precision Biosensor | Exdia COVID-19 Ag | ‘21.8.10 | Rapid Antigen |
| 31 | MiCo BioMed | VER-Q COVID-19 Ag Rapid Test | ’21.8.20 | Rapid Antigen |
| 32 | Wells Bio | careUS COVID-19 antigen | ’21.8.25 | Rapid Antigen |
| 33 | Asan | Asan Easy Test COVID-19 Ag | ’21.9.9. | Rapid Antigen |
| 34 | Abbott Rapid | Panbio COVID-19 Ag Rapid Test Device | ’21.9.28 | Rapid Antigen |
*The first two home test kits conditionally approved by Ministry of Food and Drug Safety.
Korean J healthc assoc Infect Control Prev 2021;26:47~56 https://doi.org/10.14192/kjicp.2021.26.2.47
© Korean J healthc assoc Infect Control Prev