The U.S. Food and Drug Administration (FDA) is reminding the public and health care providers that results from currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.
While a positive antibody test result can be used to help identify people who may have had a prior SARS-CoV-2 infection, more research is needed in people who have received a COVID-19 vaccination. Currently authorized SARS-CoV-2 antibody tests have not been evaluated to assess the level of protection provided by an immune response to COVID-19 vaccination. If antibody test results are interpreted incorrectly, there is a potential risk that people may take fewer precautions against SARS-CoV-2 exposure. Taking fewer steps to protect against SARS-CoV-2 can increase their risk of SARS-CoV-2 infection and may result in the increased spread of SARS-CoV-2.
The FDA is providing additional information and recommendations to the public and health care providers about the use of antibody tests in people who received a COVID-19 vaccination.
abfind post vaccination neutralizing antibody test
Recommendations for People Who Had or May Have a SARS-CoV-2 Antibody Test
Be aware that SARS-CoV-2 antibody tests help health care providers identify whether someone has antibodies to SARS-CoV-2, the virus that causes COVID-19, indicating a prior infection with the virus. However, more research is needed to understand the meaning of a positive or negative antibody test, beyond the presence or absence of antibodies, including in people who received a COVID-19 vaccination, in people who have been exposed and have SARS-CoV-2 antibodies, and in people who are not fully vaccinated.
If you have not been vaccinated: Be aware that a positive result from an antibody test does not mean you have a specific amount of immunity or protection from SARS-CoV-2 infection. If you have a positive test result on a SARS-CoV-2 antibody test, it means that it is possible you were previously infected with the SARS-CoV-2 virus. Talk with your health care provider about the meaning of your SARS-CoV-2 antibody test results.
If you received a COVID-19 vaccination: Continue to follow the CDC’s recommendations for fully vaccinated people. Be aware that if you have a positive test result on a SARS-CoV-2 antibody test, it is possible you were previously infected with SARS-CoV-2. A COVID-19 vaccination may also cause a positive antibody test result for some but not all antibody tests. You should not interpret the results of your SARS-CoV-2 antibody test as an indication of a specific level of immunity or protection from SARS-CoV-2 infection. Talk to your health care provider or your state and local health departments if you have questions about whether an antibody test is right for you.
Recommendations for Health Care Providers
At this time, do not interpret the results of qualitative, semi-quantitative, or quantitative SARS-CoV-2 antibody tests as an indication of a specific level of immunity or protection from SARS-CoV-2 infection after the person has received a COVID-19 vaccination. While a positive antibody test can indicate an immune response has occurred (seroconversion), and failure to detect such a response may suggest a lack of immune response, more research is needed. Currently authorized SARS-CoV-2 antibody tests are not validated to evaluate specific immunity or protection from SARS-CoV-2 infection. SARS-CoV-2 antibody tests should be ordered only by health care providers who are familiar with the use and limitations of the test. For more information about antibody tests for SARS-CoV-2, see Serology/Antibody Tests: FAQs on Testing for SARS-CoV-2.
Be aware that vaccines trigger antibodies to specific viral protein targets. For example, currently authorized COVID-19 mRNA vaccines induce antibodies to the spike protein and not to nucleocapsid proteins that are likely detected only after natural infections. Therefore, COVID-19 vaccinated people who have not had previous natural infection will receive a negative antibody test result if the antibody test does not detect the antibodies induced by the COVID-19 vaccine. If you are considering antibody testing in vaccinated individuals, follow the Centers for Disease Control and Prevention’s guidelines for antibody testing. For more information about antibody test performance visit EUA Authorized Serology Test Performance.
Description: Anti-BCMA Neutralizing Antibody, is produced from a hybridoma resulting from fusion of SP2/0 myeloma and B-lymphocytes obtained from a mouse immunized with BCMA.
Cytomegalovirus gB Late Neutralizing Antigen (CMV-LA gB Neutralizing) Antibody (FITC)
Description: This anti-BTLA antibody is a purified recombinant human monoclonal antibody which recognizes the human BTLA protein. BTLA (B- and T-lymphocyte attenuator) belongs to the CD28 immunoglobulin superfamily (IgSF) and is an immune-regulatory receptor that binds to HVEM (Herpesvirus entry mediator, also known as TNFRSF14, Tumor necrosis factor receptor superfamily member 14). This antibody has been tested for specific binding to purified human BTLA protein and neutralizes the interaction between BTLA and HVEM.
Description: Human, recombinant monoclonal antibody recognizing the RANKL protein, also known as TNFSF11 antibody and CD254 antibody. This antibody recognizes human RANKL. It has not been tested with other species. MW= 50 kDa (Heavy chain); 24 kDa (Light chain).
