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Manufacturers have been putting COVID-19 antibody tests on the market since mid-March, but today the U.S. Food and Drug Administration (FDA) said it's cracking down to help ensure these tests are accurate.

FDA Goes After Unproven COVID-19 Antibody Tests

MONDAY, May 4, 2020 (HealthDay News) -- The U.S. Food and Drug Administration said Monday it will crack down on the fraudulent COVID-19 antibody tests that have flooded the market.

Companies selling coronavirus antibody tests will be required to submit data proving accuracy within the next 10 days, or their products could be yanked from public circulation, FDA officials said.

Since mid-March, dozens of manufacturers have been allowed to sell antibody tests without providing any evidence they are accurate, under the initial policy announced by the FDA.

The intent of the initial policy was to support "the availability of antibody tests, which are an important tool in our fight against the coronavirus," FDA Commissioner Dr. Stephen Hahn explained during a media briefing.

Unfortunately, many of the tests that came onto the market simply aren't accurate.

A recent assessment of 14 coronavirus antibody tests now available to consumers revealed that only three delivered consistently reliable results, according a report issued by a team of more than 50 scientists.

Read the full HealthDay story.

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Mabel Jong from our liveblog team speaks with Dr. Mary Beth Son, Program Director of Boston Children's Hospital's Rheumatology Program, and Brian Padla, father of James Padla, who has MIS-C.

Watch the in-depth discussion above, and see our past HealthDay Nows and other videos on our YouTube channel.


HD Live! Videos

Watch our latest HD Live! as we take a look at the global COVID-19 vaccination rollout and how the United States rollout compares.

Mabel Jong from our liveblog team speaks with Dr. Ran Balicer of Clalit Health Services and Dr. Arnold Monto of University of Michigan School of Public Health.

Watch the in-depth discussion above, and see our past HD Lives and other videos on our YouTube channel.

UPDATE 1/26/21: Since our HD Live! interview with CEO Andrei Doroshin, the Philadelphia Health Department has severed its ties with the organization. The nonprofit has changed its status to a for-profit entity.

Watch our latest HD Live! as we take a look at Philly Fighting Covid, a nonprofit organization run by graduate students from Drexel University that aims to help with mass COVID-19 vaccination in Philadelphia.

Mabel Jong from our liveblog team speaks with Andrei Doroshin, founder of Philly Fighting Covid.

Watch the in-depth discussion above, and see our past HD Lives and other videos on our YouTube channel.

Watch our latest HD Live! as we take a deep dive into the vaccine rollout across the country.

Mabel Jong from our liveblog team speaks with Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota and a member of the Biden COVID-19 Advisory Board.

Watch the in-depth discussion above, and see our past HD Lives and other videos on our YouTube channel.

Watch our latest HD Live! as we take a deep dive into the latest information on the COVID-19 vaccines, including the rollout process, potential side effects, supply and distribution.

Mabel Jong from our liveblog team speaks with Dr. Paul Offit, Director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children's Hospital of Philadelphia and one of the physicians on the FDA Vaccines and Related Biological Products Advisory Committee.

Watch the in-depth discussion above, and see our past HD Lives and other videos on our YouTube channel.

Watch our latest HD Live! as we take a look back and a look ahead at COVID-19 and its impact on the United States and its healthcare workers.

Mabel Jong from our liveblog team speaks with Dr. David Shulkin, former Secretary of Veterans Affairs, ex-CEO of Beth Israel Medical Center in New York and an accomplished healthcare executive, and Dr. Joel Zivot, anesthesiologist and clinician at Emory University Hospital ICU.

Watch the in-depth discussion above, and see our past HD Lives and other videos on our YouTube channel.

Watch our latest HD Live! with Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID).

Mabel Jong from our liveblog team speaks with Dr. Anthony Fauci about the latest on COVID-19, including the vaccines, the infection rates and the future.

Watch the in-depth discussion above, and see our past HD Lives and other videos on our YouTube channel.

Our latest HD Live! is a conference wrap-up of the American Heart Association Scientific Sessions 2020.

Mabel Jong from our liveblog team speaks with Dr. Donald Lloyd-Jones, American Heart Association President-Elect, for a summary of the highlights of the AHA Scientific Sessions 2020.

Watch the in-depth discussion above, and see our past HD Lives and other videos on our YouTube channel.

Our latest HD Live! discussion is on how healthcare in America could be impacted by a Trump or Biden victory.

Mabel Jong from our liveblog team speaks with Marianne Udow-Phillips, director of the Center for Health and Research Transformation at the University of Michigan, and Brian Blase, who served as a healthcare adviser to President Trump from 2017-2019 and is now president and CEO of Blase Policy Strategies.

Watch our in-depth discussion above, and see our past HD Lives and other videos on our YouTube channel.