• SARS-CoV-2 Antibody Tests can be ordered by healthcare providers to test human plasma or serum to detect if there has been an adaptive immune response to COVID-19, indicating recent or prior infection.
  •  SARS-CoV-2 Antibody Tests should not be used to diagnose or exclude acute infection and should not be used as the sole basis for treatment or patient management decisions. Direct testing for SARS-CoV-2 should be performed if acute infection is suspected.
  • SARS-CoV-2 Antibody Tests are authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a.
  • This test has been validated and the FDA has been notified. This test has not been approved by the FDA. A negative result does not rule out SARS-CoV-2 infection. This antibody test result should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.