The antibody tests and the molecular tests (together referred to as “tests”) have not been cleared or approved by the Food and Drug Administration (FDA);
The FDA has authorized the use of some tests by certain laboratories under Emergency Use Authorization (EUA);
The antibody tests have been authorized for the detection of antibodies against SARS-CoV-2 only, and not for the detection of any other viruses or pathogens;
The molecular (PCR) tests have been authorized for the detection of nucleic acid from SARS-CoV-2 only, and not for the detection of any other viruses or pathogens; and
Tests are only authorized for as long as the circumstances exist to justify 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.