Antibody Tests May Answer Public Health Questions

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Some employers are using antibody tests, also known as serological tests, to decide which employees may return to work or work on the frontlines, but are they accurate enough to be a good measure of safety?

. Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance,” Anand Shah, MD, FDA deputy commissioner for Medical and Scientific Affairs, and Jeff Shuren, MD, FDA director, Center for Devices and Radiological Health, said on the agency’s website.

The manufacturers of the 12 antibody tests that the FDA has authorized for emergency include big commercial laboratories and medical device manufacturers like Abbott and Roche as well as Mount Sinai Hospital Clinical Laboratory and Wadsworth Center, New York State Department of Health.and is adding the results from the independent validation performed by other federal agencies including the National Cancer Institute as they become available, according to an FDA spokesperson.

Mina says the timing of antibody testing is important. It takes about 1 to 3 weeks after someone becomes infected with SARS-CoV-2 for their body to make antibodies, and some people may take longer. The FDA and some health care providers recommend a second test for confirmation. “The result of a single antibody test is not likely to be sufficiently accurate to make an informed decision regarding whether or not an individual has had a prior infection or truly has antibodies to the virus. A second test, typically one assessing for the presence of antibodies to a different viral protein, generally would be needed to increase the accuracy of the overall testing results,” says the FDA.

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