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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Evaluation of Enzyme-Linked Immunoassay and Colloidal Gold- Immunochromatographic Assay Kit for Detection of Novel Coronavirus (SARS-Cov-2) Causing an Outbreak of Pneumonia (COVID-19)

Detection Principle
ImmunoAssay-Antibody
Target
IgM/IgG
Testing Method Category
 
Testing Method
ELISA individual-kit, GICA individual-kit
Testing Method - Additional Info
ELISA kit: Zhu Hai Liv Zon Diagnostics; GICA kit: Zhu Hai Liv Zon Diagnostics
Reported Performance
Specificity: 100% (ELISA and GICA) ; Sensitivity: 44, 8% (IgM, ELISA), 82.5% (IgG, ELISA, 87.3 % (IgG+IgM, ELISA), 57.1% (IgM, GICA), 81.3% (IgG, GICA), 82.4% (IgG+IgM, GICA)
Sample Size
63 patients (ELISA), 91 patients (GICA)
Peer-reviewed
no

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