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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
N1 and N2
Testing Method Category
Testing Method
CoV-QS(MiCoBioMed;SouthCorea)and2019-nCoV CDC EUA kit (IDT, USA)
Testing Method - Additional Info
the performance in terms of positive percent agreement(PPA) of nCoV-QS (MiCoBioMed;SouthCorea) and 2019-nCoV CDC EUA kit (IDT, USA)
Reported Performance
Positive percentage agreement (PPA) for nCoV-QS: 66.7 % , MiCBioMedan PPA:70.5 %; Adapted CDC PPA: 62.5%
Sample Size
54 specimens

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