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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Scientific literature on COVID-19 Test Methods and Devices - detail

Comparison of commercial RT-PCR diagnostic kits for COVID-19

Detection Principle
NucleicAcid-PCR based
E, S, ORF1ab, N, RdRp genes
Testing Method Category
Testing Method
7 commercial RT-PCR kits compared
Reported Performance
PCR efficiency: >96% (all tests) ; sensitivity: 13/16 (R-Biopharm AG), 12/16 (BGI, KH Medical, Seegene), 11/16 (CerTest BioTec), 10/16 (Altona Diagnostic, PrimerDesign) ; LOD95%: 3.8 cpu (Altona Diagnostic E- and S-gene), 23 cpu (PrimerDesign), 0.91 cpu (in-house Corman E-gene), 4.3 cpu (BGI and R-Biopharm AG, KH Medical S-gene), 4.8 cpu (CerTest Biotec N-gene, KH Medical ORF1ab/RdRp), 18 cpu (CerTest Biotec Orf1ab/RdRp)
Sample Size
16 patients Covid19 positive, 6 patients other respiratory viral infections

The database contains available information from scientific literature that is being updated periodically. Please note that the provided information (as retrieved from analysed papers) is provided only for devices commercially available with CE-IVD mark. Acknowledgements