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Test Code COVID IGG SARS-CoV-2 IgG

Important Note

THIS ANTIBODY TEST SHOULD NOT BE USED TO DIAGNOSE OR EXCLUDE ACUTE SARS-COV-2 INFECTION.

An electronic or written request from a provider is required for this test to be collected and performed.

Patients must be provided an informational brochure or flier when being collected for this test.  Brochures are available upon request.

Biohazard Infectious

Performing Laboratory

Memorial Hospital - Automated Procedures Lab

Specimen Requirements

Preferred: Gold Top SST (serum) tube

Acceptable: Red top (serum) tubes, Lithium Heparin (plasma) tubes

 

Spin and separate serum/plasma from cells within two hours

 

Unacceptable specimens:  Grossly hemolyzed or lipemic samples or samples meeting any other rejection criteria.

Storage and Stability

Temperature Stability
Room Temperature (15 - 30°C) 8 hours
Refrigerated (2 - 8°C) 48 hours
Frozen (-20°C or colder) 30 days

 

Methodology

The Access SARS-CoV-2 IgG assay is a two-step enzyme immunoassay detecting antibodies to the receptor binding domain of the S1 protein of the SARS-CoV-2-IgG virus.

Days Test Set Up and Turnaround

Testing is performed in the morning Monday through Friday.

Specimens not received by the time testing is performed that day will be held to the next run.

Result Interpretation

Non-Reactive = SARS-CoV-2 IgG antibodies were not detected or below the limit of detection

Equivocal = Recommend a new sample be collected in one to two weeks

Reactive = SARS-CoV-2 IgG antibodies detected

IMPORTANT NOTE

If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. Non-reactive results do not preclude acute SARS-CoV-2 infection. Reactive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains. This test is not designed for screening donated blood.  It is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. This test is not yet approved or cleared by the US FDA. It has been made available through the current Emergency Use Authorization (EUA) and has been evaluated in accordance with CLIA standards.