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FDA grants emergency authorization to first over-the-counter, at-home COVID antigen test

15 December 2020
Dan Ackermann

The Food and Drug Administration granted emergency authorization Tuesday to Ellume's over-the-counter antigen COVID-19 test for fully at-home use.

Why it matters: Once available, a person in theory would be able to buy the test in a drug store, swab their nose, and run the test for results in about 20 minutes.

  • The company anticipates selling the test at about $30 or less. Ellume's goal is to produce 3 million tests by January and to deliver 20 million tests by the first of half of next year.

The big picture: Currently, home kits that test for the novel coronavirus either still need a prescription or require swabs be shipped to a lab, which could take days for results.

How it works: The rapid test can be used by symptomatic and asymptomatic users ages 2 years and above. This type of test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample.

  • A clinical study demonstrated overall sensitivity of 95% and specificity of 97%, according to Ellume.

Yes, but: Like all other antigen tests, "a small percentage of positive and negative results from this test may be false," the FDA notes.

  • "Patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible."

Transcripts show George Floyd told police "I can't breathe" over 20 times

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Newly released transcripts of bodycam footage from the Minneapolis Police Department show that George Floyd told officers he could not breathe more than 20 times in the moments leading up to his death.

Why it matters: Floyd's killing sparked a national wave of Black Lives Matter protests and an ongoing reckoning over systemic racism in the United States. The transcripts "offer one the most thorough and dramatic accounts" before Floyd's death, The New York Times writes.

The state of play: The transcripts were released as former officer Thomas Lane seeks to have the charges that he aided in Floyd's death thrown out in court, per the Times. He is one of four officers who have been charged.

  • The filings also include a 60-page transcript of an interview with Lane. He said he "felt maybe that something was going on" when asked if he believed that Floyd was having a medical emergency at the time.

What the transcripts say:

  • Floyd told the officers he was claustrophobic as they tried to get him into the squad car.
  • The transcripts also show Floyd saying, "Momma, I love you. Tell my kids I love them. I'm dead."
  • Former officer Derek Chauvin, who had his knee on Floyd's neck for over eight minutes, told Floyd, "Then stop talking, stop yelling, it takes a heck of a lot of oxygen to talk."

Read the transcripts via DocumentCloud.