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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Analytical performance of lateral flow immunoassay for SARS-CoV-2 exposure screening on venous and capillary blood samples

Detection Principle
ImmunoAssay-Antibody
Target
IgM and IgG
Testing Method Category
LFIA
Testing Method
Biolidics 2019-nCoV IgG/IgM Detection Kit lateral flow immunoassay
Testing Method - Additional Info
Validation of the lateral flow immunoassay (LFI) for rapid sxcreeninf and qualitative detection of anti-SARS-CoV2
Reported Performance
Specificity IgM: 92%; Specificity IgG: 100%; Specificity IgM and IgG: 92%; Day 0 Sensitivity IgM: 29%; D0 Sensitivity IgG: 21%; Day 0 Sensitivty IgM and IgG: 29%; Day7 Sensitivity IgM: 54%; D7 Sensitivity IgG: 88%; D7 Sensitivity IgM and IgG: 92% ; Plasma Sensitivity IgM: 59%; Plasma Sensitivity IgG: 86%; Plasma Sensitivity IgM and IgG: 95%; Whole Blood Sensitivity IgM: 55%; Whole Blood Sensitivity : 86%; Whole Blood Sensitivity IgM and IgG: 95%; Capillary Sensitivity IgM: 43%; Capillary Sensitivity IgG: 68%; Capillary Sensitivity Igm and IgG: 93%;
Sample Size
62 patients
Peer-reviewed
yes

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