COVID-19, Coronavirus, SARS-CoV-2, Antibody IgG
This test is designed for detection of antibodies to SARS-CoV-2 in plasma from individuals suspected to be recovering, or recovered, from COVID-19 by their healthcare provider. It can be used to:
· Identify potential convalescent plasma donors
· Support diagnosis of acute COVID-19 illness in persons who present late. For persons who present 9–14 days after illness onset, serologic testing can be offered in addition to the recommended viral direct detection methods
· Support a diagnosis when patients present with late complications of COVID-19 illness, such as multisystem inflammatory syndrome in children
· Support epidemiologic studies and for surveillance purposes, such as understanding the transmission dynamics of the virus in the general population
Samples collected in gel
barrier tubes must be removed from the primary tube prior to transporting to
Marshfield. Do not send primary collection tube.
Interference: Avoid lipemic and hemolyzed samples.
Heterophile antibodies or human anti-animal antibodies (HAMA) may interfere and cause erroneous results.
Testing was performed using Beckman Access SARS-CoV-2 IgG II assay, under Emergency Use Authorization (EUA).
Fact sheets for this Emergency Use Authorization (EUA) assay can be found at the following links:
For Healthcare Providers: https://www.fda.gov/media/146899/download
For Patients: https://www.fda.gov/media/146900/download
Reported as REACTIVE or NON-REACT
REACTIVE (>= 10 AU/mL): Antibodies to SARS-CoV-2 IgG detected.
NON-REACT (< 10 AU/mL): No IgG antibodies to SARS-CoV-2 detected.