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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Comparison and Application of Different Immunoassay Methods for the Detection of SARS-CoV-2

Detection Principle
IgM, IgG
Testing Method
kits (CLIA and colloidal gold)
Testing Method - Additional Info
SARS?CoV?2 IgM and IgG antibody chemiluminescence detection kits were from Maccura Biotechnology Co, Ltd and Bioscience (Tianjin) Diagnostic Technology Co, Ltd; SARS?CoV?2 colloidal gold test kits came from Innovita (Tangshan) Biological Technology Co, Ltd and Zhuhai Livzon Diagnostics Inc
Reported Performance
positive rate: 50% (IgM, CLIA, <7 dpo), 40% (IgM, colloidal gold, <7 dpo), 90% (IgM, CLIA, 14 dpo), 80% (IgM, colloidal gold, 14 dpo), 100% (IgM, CLIA & colloidal gold, >21dpo), 45% (IgG, CLIA, <7 dpo), 30% (IgG, colloidal gold, <7 dpo), 90% (IgG, CLIA, 14 dpo), 60% (IgG, colloidal gold, 14 dpo), 95% (IgG, CLIA & colloidal gold, >21dpo)
Sample Size
169 patients

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