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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Analysis of SARS-CoV-2 Antibodies in COVID-19 Convalescent Plasma using a Coronavirus Antigen Microarray.

Detection Principle
ImmunoAssay-Antigen
Target
spike protein (S), including the receptor-binding (RBD), S1, and S2 domains and the whole protein (S1?+?S2), nucleocapsid protein (NP), and papain-like protease (PLpro)
Testing Method Category
Other Immuno assay
Testing Method
ONCYTE AVID nitrocellulose-coated slides (Grace Bio-Labs, Bend
Testing Method - Additional Info
validation of a coronavirus antigen microarray containing immunologically significant antigens from SARS-CoV-2, in addition to SARS-CoV, MERS-CoV, common human coronavirus strains, and other common respiratory viruses. 
Reported Performance
IgG SARS.CoV.2.S1.mFcTag Sensitivity: 0.5629; Specificity: 0.9849; IgM SARS.CoV.2.Spike.RBD.rFc Sensitivity: 0.5894; Specificity: 0.9873; Combination of IgG and IgM sensitivity: 87.8%; Specificity: 98.9%
Sample Size
135 blood 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