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 and N2
Testing Method Category
RT-PCR
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
Peer-reviewed
yes
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