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
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