Quanta Inc (fka QNTA)

[~MulaGreen~]

FDA WARNING...COVID-19 Part 1 Date Issued: May 19, 2021

Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication

https://www.fda.gov/medical-devices/safety-communications/antibody-testing-not-currently-recommended-assess-immunity-after-covid-19-vaccination-fda-safety

Date Issued: May 19, 2021

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.