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Use: To evaluate for evidence of previous SARS-CoV-2 infection in individuals with a history of COVID-19 vaccination to aide in the diagnosis of Multisystem Inflammatory Syndrome in children (MIS-C) or adults (MIS-A). The presence of antibodies specific to the SARS-CoV-2 viral nucleocapsid protein is consistent with natural infection as currently available COVID-19 vaccines induce antibodies against the viral spike protein receptor binding domain (RBD) only.
Limitations: 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.
These tests have not been FDA cleared or approved. These tests have been authorized by FDA under an Emergency Use Authorization (EUA). These tests are 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.
Methodology: Electrochemiluminescence Immunoassay (ECLIA)
