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Specimens submitted for detection of IgG antibodies to SARS-CoV-2 (COVID 19) spike antigen are tested using a chemiluminescent microparticle immunoassay (CMIA). The CMIA provides qualitative detection of SARS-CoV-2 IgG spike antibodies on the Diasorin Liaison instrument. Results are reported as positive or negative along with a value in Arbitrary Units (AU) per milliliter (AU/mL).
The Diasorin LIAISON SARS-CoV-2 IgG test has Emergency Use Authorization by the FDA as of April 26, 2020. The manufacturer’s performance specifications indicate a negative percent agreement of 99.5% based on analysis of 1899 pre-COVID-19 outbreak samples. Positive percent agreement (PPA) is 96.9%, based on testing of 32 subjects who tested positive by a SARS-CoV-2 PCR assay, varies by the time after disease onset. Samples should not be tested if collected from individuals less than 15 days post symptom onset.
This test detects IgG antibodies to a recombinant SARS-CoV-2 Trimeric spike protein.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
Positive results do not rule out the potential for re-infection or indicate immunity to SARS-CoV-2 infection.
This test is not recommended for samples collected less than seven days after onset due to low sensitivity in the first week after onset.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This test detects antibodies induced by currently approved vaccines as well as by infection with SARS-CoV-2.
Fact Sheets for Patients and Providers contain further information on antibody testing for SARS-CoV-2
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