Approved: New Kind of COVID-19 Test

FDA approves COVID-19 tests that can estimate quantity of antibodies

(RxWiki News) The US Food and Drug Administration (FDA) has authorized two new COVID-19 tests.

These are the first two COVID-19 serology tests that can estimate the number of antibodies someone has from a past SARS-CoV-2 infection.

These tests, both from Siemens, are found under the names ADVIA Centaur COV2G and Atellica IM COV2G.

The FDA noted that these tests do not come up with an exact number of COVID-19 antibodies — just an estimate.

“There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorizations give us additional tools to evaluate those antibodies as we continue to research and study this virus," said Dr. Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, in a press release. "Patients should not interpret results as telling them they are immune, or have any level of immunity, from the virus."

The FDA encouraged consumers not to stop taking measures to protect themselves and their families, despite getting results from these tests or any other serology tests showing the presence of antibodies. The agency continued to strongly encourage social distancing and wearing masks, among other safety measures.

Here are a few things you can do to help protect yourself from COVID-19:

  • Avoid large crowds and practice social distancing.
  • Avoid close contact with people who are sick.
  • Avoid touching your eyes, nose and mouth.
  • Wash your hands frequently. Wash with soap and water for at least 20 seconds. If soap and water are not available, you can use hand sanitizer that has at least 60 percent alcohol. It’s especially important to wash:
    • Before eating or preparing food
    • Before touching your face
    • After using the restroom
    • After leaving a public place
    • After touching your mask
  • Disinfect surfaces, buttons, handles, knobs and other places that are touched often.

The FDA noted that serology tests are not to be used as a way to diagnose an active infection. They only can detect antibodies that the immune system developed in response to the virus.

Last Updated:
August 7, 2020