Table 1
Emergency use authorized molecular diagnostic kits for COVID-19 in Korea

Purpose Approval date Name (manufacturer name) Test methods Target gene Cutoff Ct value
Diagnostic Feb 4, 2020 PowerChek 2019-nCoV Real-time PCR Kit (KogeneBiotech) Real-time RT-PCR E, RdRp <35
Feb 12, 2020 Allplex 2019-nCoV Assay (Seegene) Real-time RT-PCR E, RdRp, N <40
Feb 27, 2020 STANDARD M nCoV Real-Time Detection Kit (SD Biosensor,) Real-time RT-PCR E, ORF1ab (RdRp) <46
Feb 27, 2020 DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit (SolGent) Real-time RT-PCR ORF1a, N <40
Mar 13, 2020 Real-Q 2019-nCoV Detection Kit (BioSewoom) Real-time RT-PCR E, RdRp <38
May 8, 2020 BioCore 2019-nCoV Real Time PCR Kit (BioCore) Real-time RT-PCR RdRp, N <40
May 28, 2020 careGENE N-CoV RT-PCR Kit (Wells Bio) Real-time RT-PCR E, RdRp <45
Rapid Jun 24, 2020 Ezplex SARS-CoV-2 FAST Kit (SML Genetree) Real-time RT-PCR RdRp, N <38
Jun 24, 2020 Real-Q Direct SARS-CoV-2 Detection Kit (BioSewoom) Real-time RT-PCR E, RdRp <38
Jun 24, 2020 LabGun COVID-19 Fast RT-PCR Kit (LabGenomics) Real-time RT-PCR E, RdRp <40
Jul 24, 2020 AQ-TOP COVID-19 Rapid Detection Kit Plus (SeaSun Biomaterials) Real-time LAMP ORF1ab, N <30
Jul 24, 2020 nCoV-QS (MiCo BioMed) Real-time RT-PCR ORF3a, N <40
Jul 24, 2020 BioFire Respiratory Panel 2.1 (biomerieux) Multiplex nested PCR S, M NA*
Jul 24, 2020 Xpert Xpress SARS-CoV-2 (Cepheid) Real-time RT-PCR E, N2 <45
Jul 24, 2020 iDetect SARS-CoV-2 Detection Kit (COSMAX PHARMA) Real-time LAMP RdRp, N <36
Jul 24, 2020 A+CheQ COVID-19 High Speed RT-qPCR Detection Kit (AMSBIO) Real-time RT-PCR ORF1ab, N <36
COVID-19, coronavirus disease 2019; Ct, cycle threshold; RT, reverse transcription; LAMP, loop mediated isothermal amplification; NA, not available.
*BioFire Respiratory Panel 2.1 does not provide a quantitative value.