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Accuracy concerns arise after FDA allows COVID-19 antibody tests to be sold without authorization

Many tests give inconsistent results

DETROIT – There are concerns about the accuracy of antibody tests that would help determine if someone had and recovered from coronavirus (COVID-19).

The Food and Drug Administration has granted emergency use authorizations to four antibody tests. Tests from Cellex, Ortho Clinical Diagnostics, ChemBio Diagnostics and Mount Sinai Health System are the only ones authorized.

However, the administration is also allowing about 90 companies to sell antibody tests without authorization or review. These companies are expected to self-validate the tests to ensure they are accurate.

According to Sean Tabibian’s diagnostic lab, 70 percent of tests from five different companies that do not have FDA approval provided inconsistent results.

“These rapid test kits are dangerous,” he said. “They’re giving false positives or negatives. It might give people a false sense of security that they somehow have immunity.”

A Texas health department also had similar results. One brand of test kits it tried was only 20 percent reliable. The company claimed up to 97 percent accuracy.

The FDA is working with the Centers for Disease Control and Prevention to help validate some tests and make them more accurate.

How COVID-19 Spreads

Person-to-person spread

The virus is thought to spread mainly from person-to-person.

  • Between people who are in close contact with one another (within about 6 feet).
  • Through respiratory droplets produced when an infected person coughs or sneezes.

These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs.

Can someone spread the virus without being sick?

  • Spread is possible before people show symptoms. People who are not showing symptoms can still be carrying the virus and can still pass it on to other people.

Spread from contact with contaminated surfaces or objects

It may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes, but this is not thought to be the main way the virus spreads.

How easily the virus spreads

How easily a virus spreads from person-to-person can vary. Some viruses are highly contagious (spread easily), like measles, while other viruses do not spread as easily. Another factor is whether the spread is sustained, spreading continually without stopping.

Prevention & Treatment

There is currently no vaccine to prevent coronavirus disease 2019 (COVID-19). The best way to prevent illness is to avoid being exposed to this virus. However, as a reminder, CDC always recommends everyday preventive actions to help prevent the spread of respiratory diseases, including:

  • Avoid close contact with people who are sick.
  • Avoid touching your eyes, nose, and mouth.
  • Stay home when you are sick.
  • Cover your cough or sneeze with a tissue, then throw the tissue in the trash.
  • Clean and disinfect frequently touched objects and surfaces using a regular household cleaning spray or wipe.

Wash your hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after blowing your nose, coughing, or sneezing.


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