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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Diagnostic performance of COVID-19 serology assays

Detection Principle
total antibody, IgG and IgM separately, antigen
Testing Method Category
Testing Method
SARS-CoV-2 Antibody test (Biologix Corporation); WONDFO One Step COVID-19 (SARS-CoV-2 Antibody Test) (Guangzhou Wondfo Biotech); Diagnostic kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Zhuhai Livzon Diagnostic Inc.); Eugene SARS-CoV-2 (COVID-19) IgG/IgM Rapid Test (Shanghai Eugene Biotech); COVID-19 IgG/IgM Rapid Test (Healgen Scientific); COVID-19 IgM/IgG Ab Rapid Test (Qi ngdao hightop Biotech Co., Ltd); VivaDiag COVID-19 IgM/IgG Rapid Test (VivaChek Laboratories); Standard Q COVID-19 IgM/IgG Duo Test (SD Biosensor); COVID-19 IgG/IgM Rapid Test (PureCheck).
Testing Method - Additional Info
Full article available at:
Reported Performance
total antibody: sensitivity 86.4% to 90.6%; specificity >99%. IgM/IgG tests: sensitivity: 72.7% to 100%; specificity: 98.7% to 100%; positive coincidence rate: 37.5% to 97.1% and negative coincidence rate: 96% to 100%.

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