Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Point-of-care serological assays for delayed SARS-CoV-2 case identification among health-care workers in the UK: a prospective multicentre cohort study

Detection Principle
ImmunoAssay-Antibody
Target
IgG
Testing Method Category
LFIA
Testing Method
kits (CTK Biotech, Zhuhai Encode)
Testing Method - Additional Info
two point-of-care lateral flow serological assays, the Onsite CTK Biotech COVID-19 split IgG/IgM Rapid Test (CTK Biotech, Poway, CA, USA) and the Encode SARS-CoV-2 split IgM/IgG One Step Rapid Test Device (Zhuhai Encode Medical Engineering, Zhuhai, China), were evaluated for performance against a laboratory immunoassay (EDI Novel Coronavirus COVID-19 IgG ELISA kit [Epitope Diagnostics, San Diego, CA, USA])
Reported Performance
Sensitivity: 93.4% (Encode), 88.2% (Onsite); Specificity: 99% (Encode), 94% (Onsite); Agreement with PCR: 94% (Encode), 84.7% (Onsite)
Sample Size
400 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