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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.

In our latest HealthDay Now, Mabel Jong spoke with Dr. Lori Pierce, president of the American Society of Clinical Oncology and a cancer radiation specialist at the University of Michigan.

Dr. Pierce shared important takeaways from the recently concluded 2021 ASCO annual meeting and discussed why equity was the chosen theme this year.

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 HealthDay Now as we cover the latest on the Johnson & Johnson COVID-19 vaccine investigation. An independent advisory panel to the CDC is waiting on additional information before making recommendations on the use of the Johnson & Johnson COVID-19 vaccine after reports about rare blood clots.

Mabel Jong from our liveblog team speaks with Lynn Bahta, a member of the CDC's Advisory Committee on Immunization Practices (ACIP) and a clinical expert for vaccines at the Minnesota Department of Health.

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

Watch our latest HealthDay Now as we recap the highlights of the American Association for Cancer Research (AACR) Annual Meeting 2021.

Mabel Jong from our liveblog team speaks with Dr. Antoni Ribas, former president of the American Association for Cancer Research and professor of medicine at UCLA, and Anna Plym, PhD, a postdoctoral research fellow at Brigham and Women's Hospital.

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

Watch our latest HealthDay Now as we dive into the latest details on multisystem inflammatory syndrome in children (MIS-C).

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.


Watch our latest HealthDay Now as we debunk myths about the COVID-19 vaccines and talk about what the new CDC guidelines for vaccinated people mean.

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, and Dr. Mercedes Carnethon, Vice Chair of Preventive Medicine at the Northwestern Feinberg School of Medicine.

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

Watch our latest HealthDay Now as we take a look at how living through the COVID-19 pandemic impacts children socially, mentally and emotionally.

One year in, this is their "new normal," but what does that mean for them? From social isolation to remote learning to a loss of structure and normalcy, we discuss how living during the pandemic has both short- and long-term effects on children.

Mabel Jong from our liveblog team speaks with:

  • Dr. Mark Reinecke, Department of Psychiatry & Behavioral Sciences, Northwestern University
  • Tracy Compton, a parent
  • Stephen Guerriero, a teacher
  • Jake Anderson, a student

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 at the COVID-19 pandemic and the vaccination rollout and how they've impacted people of color.

Mabel Jong from our liveblog team speaks with:

  • Tasha Clark-Amar, CEO, East Baton Rouge Council on Aging
  • Jill Ramirez, Executive Director, Latino HealthCare Forum (Austin)
  • Vickie Mays, PhD, Professor, UCLA Fielding School of Public Health

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 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.