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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 accuracy of serological tests for covid-19: systematic review and meta-analysis

Detection Principle
ImmunoAssay-Antibody
Target
IgG, IgM
Testing Method Category
 
Testing Method
ELISA, LFIA, CLIA
Testing Method - Additional Info
review and meta-analysis on serological tests
Reported Performance
Remark: Pooled sensitivity: 84.3% (ELISAs IgG or IgM), 66% (LFIAs), 97.8% (CLIAs). Pooled specificities ranged from 96.6% to 99.7%. Among LFIAs, pooled sensitivity of commercial kits (65.0%, 49.0% to 78.2%) was lower than that of non-commercial tests (88.2%, 83.6% to 91.3%). Heterogeneity was seen in all analyses. Sensitivity was higher at least three weeks after symptom onset (ranging from 69.9% to 98.9%) compared with within the first week (from 13.4% to 50.3%).
Sample Size
/
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