List of SARS-CoV-2 molecular diagnostic kit approved by Ministry of Food and Drug Safety (as of September 28, 2021)
| Manufacturer | Kit | Approval date | Detection method |
Rapid format | |
|---|---|---|---|---|---|
| 1 | SD Biosensor | STANDARDTM M nCoV Real-Time Detection kit | ‘20.8.31. | Real time RT-PCR | |
| 2 | BioSewoom | Real-Q 2019-nCoV Detection Kit | ‘20.10.6. | Real time RT-PCR | |
| 3 | SEASUN BIO | U-TOPTM COVID-19 Detection Kit Plus | ‘20.10.8. | Real time RT-PCR | |
| 4 | CANCERROP | Q-Sens® COVID-19 Detection kit | ‘20.10.8. | Real time RT-PCR | |
| 5 | Kogene Biotech | PowerChekTM SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit | ‘20.11.3. | Real time RT-PCR | |
| 6 | SEASUN BIO | AQ-TOPTM COVID-19 Rapid Detection Kit Plus | ‘20.11.23. | LAMP | Rapid |
| 7 | Kogene Biotech | PowerChekTM SARS-CoV-2 Real-time PCR Kit | ‘20.11.26. | Real time RT-PCR | |
| 8 | Seegene | Allplex SARS-CoV-2 Assay | ‘20.12.7. | Real time RT-PCR | |
| 9 | CANCERROP | Q-Sens® COVID-19 Detection Kit V2 | ‘20.12.14. | Real time RT-PCR | |
| 10 | BioSewoom | Real-Q Direct SARS-CoV-2 Detection Kit | ‘21.1.20. | Real time RT-PCR | Rapid |
| 11 | Seegene | AllplexTM SARS-CoV-2/FluA/FluB/RSV Assay | ‘21.1.26. | Real time RT-PCR | |
| 12 | SML Genetree | Ezplex® SARS-CoV-2 Kit | ‘21.1.29. | Real time RT-PCR | |
| 13 | BioCore | BioCore 2019-nCoV Real Time PCR Kit | ‘21.3.12. | Real time RT-PCR | |
| 14 | LabGenomics | LabGunTM COVID-19 ExoFast RT-PCR Kit | ‘21.3.18. | Real time RT-PCR | Rapid |
| 15 | OPTOLANE | Dr. PCRTM Di20K COVID-19 Detection kit | ‘21.3.23. | Real time RT-PCR | |
| 16 | SEASUN BIO. | U-TOPTM SARS-CoV-2 & Flu A/B | ‘21.4.1. | Real time RT-PCR | |
| 17 | OSANG Healthcare | GeneFiner COVID-19 Fast RealAmp Kit | ‘21.4.26 | Real time RT-PCR | |
| 18 | Bioneeer | Real-Q SARS-CoV-2/FluA/FluB Detection Kit | ‘21.4.26 | Real time RT-PCR | |
| 19 | Bioneeer | AccuPower® RV1 Real-Time RT-PCR Kit | ‘21.4.30 | Real time RT-PCR | |
| 20 | Roche | Cobas SARS-CoV-2 & Influenza A/B | ‘21.5.4 | Real time RT-PCR | |
| 21 | PaxGenBio | PaxView® SARS-CoV-2 real-time RT-PCR Kit | ‘21.5.12 | Real time RT-PCR | |
| 22 | Bioneeer | AccuPower® RV1 Multiplex Kit | ‘21.5.26 | Real time RT-PCR | |
| 23 | Genomictree | AccuraDTectTM COVID-19 RT-qPCR Kit | ‘21.6.17 | Real time RT-PCR | |
| 24 | SML Genetree | Ezplex® SARS-CoV2/RV Fast Kit | ‘21.6.21 | Real time RT-PCR | Rapid |
| 25 | AMSBIO | A+CheQ COVID-19 RT-qPCR Detection kit | ‘21.6.22 | Real time RT-PCR | |
| 26 | GeneMatrix | NeoPlexTM FluCOVID Kit | ‘21.7.1 | Real time RT-PCR | |
| 27 | SolGent | DiaPlexQTM Novel Coronavirus (2019-nCoV) Detection Kit | ‘21.7.22 | Real time RT-PCR | |
| 28 | GeneMatrix | NeoPlexTM COVID-19 Detection | ‘21.8.27 | Real time RT-PCR | |
| 29 | Bioneer | AccuPower® COVID-19 Multiplex Real-Time RT-PCR Kit | ’21.9.13 | Real time RT-PCR |
Abbreviations: RT-PCR, reverse transcription polymerase chain reaction; LAMP, loop-mediated isothermal amplification.
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