SARS-CoV-2 rapid molecular diagnostic kits commercially available in Korea (as of September 28, 2021)
| Kit | Manufacturer | Detection format | Approval | Claimed LOD |
|---|---|---|---|---|
| Xpert Xpress SARS-CoV-2 | Cepheid | Real-time RT-PCR | EUA | 250 copies/mL |
| BioFire Respiratory Panel 2.1 | bioMérieux | Nested multiplex PCR | EUA | 160 copies/mL |
| Real-Q Direct SARS-CoV-2 Detection Kit | Biosewoom | Real-time RT-PCR | MFDS-approved | E 6.6-9.9 copies/μL, RdRp 6.8-8.7 copies/μL |
| LabGunTM COVID-19 ExoFast RT-PCR Kit | LabGenomics | Real-time RT-PCR | MFDS-approved | 50 copies/reaction |
| Ezplex SARS-CoV-2 FAST Kit | SML Genetree | Real-time RT-PCR | MFDS-approved | 1.0-2.6 copies/μL |
| nCoV-QS | MiCo BioMed | Real-time RT-PCR | EUA | NA |
| A+CheQ COVID-19 High Speed RT-qPCR Detection Kit | AMSBIO | Real-time RT-PCR | EUA | NA |
| AQ-TOP COVID-19 Rapid Detection Kit Plus | SEASON BIO | RT-LAMP | MFDS-approved | 10 copies/reaction |
| iDetectTM SARS-CoV-2 Detection Kit | COSMAX PHARMA | RT-LAMP | EUA | RdRp114.5 copies/reaction, N 298.5 copies/reaction |
Abbreviations: EUA, emergency use authorization; LOD, limit of detection; MFDS, Ministry of Food and Drug Safety; RT-LAMP, reverse transcription 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