SARS-CoV-2 Antibody Profile, Nucleocapsid and Spike

These tests should not be used to diagnosis or exclude acute SARS-CoV-2 infection. The results should always be assessed in conjunction with patient's medical history, clinical presentation, and other findings. Negative test results do not rule out the possibility of an infection with SARS-CoV-2. Serum or plasma samples from the very early (pre-seroconversion) phase can yield negative findings. Therefore, these tests cannot be used to diagnosis an acute infection. It has also been reported that certain patients with confirmed infection do not develop SARS-CoV-2 antibodies. Furthermore, waning of antibody titers has been reported in some individuals within a range of months after infection, a feature which has also been reported for other coronaviruses.

The SARS-CoV-2 spike antibody assay has not been FDA cleared or approved. This test has been authorized by the FDA under an Emergency Use Authorization (EUA). 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-2(b)(1), unless the authorization is terminated or revoked sooner. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.