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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Clinical usefulness of fully automated chemiluminescent immunoassay for quantitative antibody measurements in COVID-19 patients

Detection Principle
ImmunoAssay-Antibody
Target
IgG, IgM vs N, S
Testing Method Category
Other Immuno assay
Testing Method
kit (MAGLUMI)
Testing Method - Additional Info
Snibe 2019?Novel Coronavirus (nCoV) Kit, a CE?IVD marked assay on MAGLUMI 800 (Shenzhen New Industries Biomedical Engineering [Snibe] Co., Ltd., Shenzhen, China),
Reported Performance
specificity: 100%; PPV: 100%; Sensitivity: 95.5% (15-25 dpo); LOD: 0.03 AU/mL (IgG), 0.58 AU/mL (IgM). Remark: table 3 and 4 present performance assessment of the method
Sample Size
276 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