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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

SARS-CoV-2 infection serology: a useful tool to overcome lockdown?

Detection Principle
ImmunoAssay-Antibody
Target
IgG/IgM vs N, S
Testing Method Category
 
Testing Method
kits
Testing Method - Additional Info
comparison of two different immunochromatographic cards (Card1: 2019-nCoV IgG/IgM Rapid Test Cassette, Hangzhou AllTest Biotech Co, Hangzhou, China); Card2: Cellex qSARS IgG/IgM Rapid Test, Cellex, Inc., NC, USA), an immunofluorescence chromatographic card (Card3: POCT-fluorescence Coronavirus IgG/IgM antibodies detection kit ,Sichuan Xincheng Biological Co., China), and a chemiluminescence-automated immunoassay (CLIA: Shenzhen Mindray Bio-Medical Electronics Co., Shenzen, China)
Reported Performance
Sensitivity: 61.4% (IgM Card1), 84.3% (IgG Card1), 87.8% (IgM Card2), 89.6% (IgG Card2), 84% (IgM Card3), 93% (IgG Card3), 84% (IgM CLIA), 95% (IgG CLIA); Specificity: 100% (IgM Card1), 100% (IgG Card1), 100% (IgM Card2), 100% (IgG Card2), 100% (IgM Card3), 100% (IgG Card3), 94% (IgM CLIA), 100% (IgG CLIA)
Sample Size
83 samples
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