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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Evaluation of nCoV-QS (MiCo BioMed) for RT-qPCR detection of SARS-CoV-2 from nasopharyngeal samples using CDC FDA EUA qPCR kit as a gold standard: an example of the need of validation studies

Detection Principle
NucleicAcid-PCR based
Target
N1, N2, RdRp (CDC); ORF3a, N (MiCo BioMed)
Testing Method Category
PCR_KIT
Testing Method
Multiple kits
Testing Method - Additional Info
nCoV-QS (MiCo BioMed), CDC FDA EUA
Reported Performance
LOD: 20 cp/ul (CDC); PPA: 66.7%
Sample Size
54 samples & 6 controls
Peer-reviewed
no

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