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Evaluation of SARS-CoV-2 Quantitative Total Antibody.
Serologic assays can play an important role in understanding viral epidemiology in the general population and identifying groups at higher risk of infection. This assay uses a recombinant protein representing the RBD of the S antigen for the quantitative determination of antibodies against SARS-CoV-2. Quantification of the antibody response can help to determine the specific antibody titer and aid in longitudinal monitoring of the dynamics of the antibody response in individual patients.
This test may detect antibodies induced by currently available SARS-CoV-2 vaccines. This test does not result in the endpoint titer of the antibody.
The results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.
A negative test result does 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, this test cannot be used to diagnose 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.
This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of the declaration that circumstances existj ustifying 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. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.
