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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests

DOI
10.3390/jcm9082369 
Detection Principle
ImmunoAssay-Antibody
Target
S protein
Testing Method Category
Mixed
Testing Method
Three comercial avaible kits: i) NTBIO DiagnosticsInc. (Surrey, British Columbia, Canada) (ii) Zhejiang Orient-Gene Biotech Co. Ltd.(Huzhou, China) (iii) MEDsan GmbH, Biological Health Solutions (Hamburg,Germany)
Testing Method - Additional Info
Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests
Reported Performance
i) NTBIO DiagnosticsInc Specificity Whole Blood: 98%; Specificity plasma: 96%; Sensitivity Whole Blood: 92%; Sensitivity Plasma 92%; Positive Predicted Value (PPV) Whole Blood: 97%; PPV Plasma: 95%; Negative predicted Value (NPV) Whole Blood: 95%; NVP Plasma: 94%; ii) Zhejiang Orient-Gene Biotech Co. Ltd. Specificity Whole Blood: 100%; Specificity Plasma 98%; Sensitivity Whole Blood: 92%; Sensitivity Plasma: 100%; PPV Whole Blood: 100%; PPV Plasma: 97%; NPV Whole Blood: 95%; NPV Plasma: 100%; iii) EDsan GmbH, Biological Health Solutions, Specificity Whole Blood: 96%, Specificity Plasma: 96%; Sensitivity Whole Blood: 100%, Sensitivity Plasma: 100%; PPV Whole Blood: 95%; PPV plasma: 95%; NPV Whole Blood: 100%; NPV plasma: 100%
Sample Size
91 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