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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Serology characteristics of SARS-CoV-2 infection since exposure and post symptom onset

Detection Principle
IgG and IgM, N and ORF1ab genes
Testing Method Category
Other Immuno assay
Testing Method
commercial ELISA, LFIA, CMIA, RT-PCR
Testing Method - Additional Info
three enzyme-linked immunosorbent assays (ELISA-Ab, ELISA-IgM and ELISA-IgG), three colloidal-gold lateral-flow immunoassays (LFIA-Ab, LFIA-IgM and LFIA-IgG) (Beijing Wantai Biological Pharmacy Enterprise Co., Ltd, Beijing, China) and two chemiluminescence microparticle immunoassays (CMIA-Ab and CMIA-IgM) (Xiamen InnoDx Biotech Co., Ltd, Xiamen, China), commercial one-step real-time reverse transcriptase polymerase chain reaction (RT-PCR) assay (Bio-Germ, Shanghai, China)
Reported Performance
Sensitivity: 97.5% (ELISA-Ab, LFIA-Ab), 96.3% (CMIA-Ab), 92.5% (ELISA-IgM), 86.3% (CMIA-IgM, LFIA-IgG), 88.8% (LFIA-IgM, ELISA-IgG) ; Specificity: 100% (ELISA-Ab, IgM, IgG), 99.3% (CMIA-Ab, IgM), 95.2% (LFIA-Ab), 98.1% (LFIA-IgM), 99.5% (LFIA-IgG)
Sample Size
80 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