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SARS-CoV-2 Total Antibodies

COVID-19 antibody(ies)
COVID-19 IgG/IgM

The ADVIA Centaur SARS-CoV-2 Total Antibody assay detects total antibodies (combined IgM/IgG) from blood specimens that are generated as part of the adaptive human immune response to the COVID-19 virus indicating recent or prior infection. Studies have shown this assay to have a sensitivity of 100% and a specificity of 99.8%. Thus the PPV (positive predictive value) at 5% prevalence is 96.5% and the NPV (negative predictive value) at 5% prevalence is 100%.

• It is unknown currently if a positive immune response is protective against future infections.
• The absence of antibodies does not exclude COVID-19 exposure or infection as it can take up to 2 weeks for antibodies to develop post exposure or symptoms.
• This assay should not be used to diagnose or exclude acute infection.
• See also Healthcare Providers Fact Sheet and Recipients Fact Sheet.

CoVTotAb

Minimum of 2.0 mL serum

SST/Gold Top or Tiger

1. Label serum separator tube (SST) with two identifiers. Acceptable identifiers include patient’s name, date of birth, social security number, requisition number, and medical record number.
2. Allow SST contents to clot in an upright position for at least 30 minutes.
3. Centrifuge within 2 hours of collection and refrigerate.

Refrigerated

1-2 days

This test has not been FDA cleared or approved. This test has been authorized by the FDA under an Emergency Use Authorization (EUA).
This test has been authorized only for the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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