Skip to main content
European Commission logo
Live, work, travel in the EU
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Evaluation of serological tests for SARS-CoV-2: Implications for serology testing in a low-prevalence setting

DOI
10.1093/infdis/jiaa467 
Detection Principle
ImmunoAssay-Antibody
Target
IgA, IgG, IgM
Testing Method Category
Other Immuno assay
Testing Method
kits: OnSite COVID-19 IgG/IgM Rapid Test; VivaDiag COVID-19 IgM/IgG Rapid Test; Hangzhou AllTest COVID-19 test; Wondfo SARS-CoV-2 Antibody Test; and Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test; EuROIMMUN Anti-SARS-CoV-2 ELISA; Coronavirus Typing assay (AusDiagnostics)
Testing Method - Additional Info
Five PoCT are compared to EUROIMMUN Anti-SARS-CoV-2 ELISA and to PCR results.
Reported Performance
ELISA overall sensitivity for IgA or IgG: 67.9%; specificity: 72.8%. sensitivity for samples collected >14 from symptoms onset: 93.8% . 5 PoCT devices with either an IgM or IgG: overall sensitivity 68.6%; specificity: 100.0%; sensitivity for samples collected >14 from symptoms onset: 93.8%. (in the text are reported performance of single kits)
Sample Size
91 positive, 92 negative
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