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: This human monoclonal antibody recognizes human V-domain immunoglobulin (Ig) suppressor of T cell activation (VISTA), and neutralizes its interaction with VSIG3 (also called IGSF11). VISTA is also known as B7-H5 or VSIR (GenBank Accession No. NM_022153). VSIG3 is a ligand involved in cell adhesion as a VISTA binding partner. This neutralizing antibody has been functionally tested using the VSIG-3:VISTA [Biotinylated] Inhibitor Screening Assay Kit (BPS Bioscience #79782).
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).
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).
Description: Neutralizing recombinant murine/human chimeric antibody recognizing the PD-L1/PD-L2 binding region of human PD-1. This antibody does not cross-react with mouse PD-1, but does cross-react with monkey (M. fascicularis) PD-1. It has not been tested with other species.
Description: Neutralizing recombinant human_x000D_chimeric antibody recognizing human IL-17A._x000D_This antibody has not been tested for crossreactivity_x000D_with other species.
Description: Purified, recombinant, humanized Anti-β-amyloid (IgG1) antibody, expressed in HEK293 cells. This antibody reacts with human β-amyloid and has not been tested for cross-reactivity with other species.
Description: Neutralizing recombinant human monoclonal antibody recognizing the extracellular domain of CTLA4 and blocking binding of CTLA4 to B7.1 and B7.2. This antibody recognizes human CTLA4 but does not bind to murine CTLA4. This antibody has not been tested for cross-reactivity with other species.
Description: Neutralizing recombinant chimeric murine/human monoclonal antibody recognizing the extracellular domain of PD-L1 and blocking the binding of PD-L1 to PD-1. This antibody has been shown to cross-react with mouse PD-L1. No other species have been tested.
Description: Purified, recombinant, human anti-PD-1 (IgG1) antibody with C-terminal Avitag, expressed in HEK293 cells. Purified antibody was enzymatically biotinylated using Avitag™ technology. This antibody does not cross-react with mouse PD-1, but does cross-react with monkey (M. fascicularis) PD-1. It has not been tested with other species.
Description: Purified, recombinant, chimeric murine/human anti-PD-L1 (IgG1) antibody with C-terminal Avi-tag, expressed in HEK293 cells. Purified antibody was enzymatically biotinylated using Avitag™ technology. This antibody reacts with human PD-L1 and cross-reacts with mouse PD-L1. It has not been tested for cross-reactivity with other species.
Description: This monoclonal antibody recognizes the SARS-CoV-2 Spike RBD (B.1.1.529, Omicron Variant) protein and neutralizes its interaction with ACE2 [Table of Variants]. The human ACE2 receptor is found on the surface of type I and II pneumocytes, endothelial cells, and ciliated bronchial epithelial cells. ACE2 is known to mediate COVID-19 infection through direct binding of the SARS-CoV-2 Spike protein. This neutralizing antibody has been functionally tested using the Spike S1 RBD (B.1.1.529, Omicron Variant) (SARS-CoV-2):ACE2 Inhibitor Screening Colorimetric Assay Kit (BPS Bioscience #78339).
Description: This monoclonal antibody recognizes the SARS-CoV-2 Spike RBD (B.1.1.529, Omicron Variant) protein and neutralizes its interaction with ACE2 [Table of Variants]. The human ACE2 receptor is found on the surface of type I and II pneumocytes, endothelial cells, and ciliated bronchial epithelial cells. ACE2 is known to mediate COVID-19 infection through direct binding of the SARS-CoV-2 Spike protein. This neutralizing antibody has been functionally tested using the Spike S1 RBD (B.1.1.529, Omicron Variant) (SARS-CoV-2): ACE2 Inhibitor Screening Colorimetric Assay Kit (BPS Bioscience, #78339).
Description: Purified recombinant human_x000D_anti-PCSK9 (IgG1) antibody with a C-terminal_x000D_Avi-tag, expressed in HEK293 cells. Purified_x000D_antibody was enzymatically biotinylated using_x000D_AviTag™ technology. This antibody reacts with_x000D_human PCSK9 and has not been tested for_x000D_cross-reactivity with other species.
Description: Purified recombinant human_x000D_anti-PCSK9 (IgG4) antibody with a C-terminal_x000D_Avi-tag, expressed in HEK293 cells. Purified_x000D_antibody was enzymatically biotinylated using_x000D_AviTag™ technology. This protein reacts with_x000D_human PCSK9 and has not been tested for_x000D_cross-reactivity with other species.
Description: Recombinant human monoclonal (clone 414-2) antibody recognizing the SARS-CoV-2 Spike S1 RBD glycoprotein. This antibody cross-reacts with the Spike protein from the SARS-CoV virus.
Description: Recombinant human monoclonal (clone 414-1) antibody recognizing the SARS-CoV-2 Spike S1 RBD glycoprotein. This antibody cross-reacts with the Spike protein from the SARS-CoV virus.
