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FDA has approved an at-home rapid coronavirus test. Here’s what we know

FDA grants the first emergency use authorization for at-home rapid coronavirus tests

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The Lucira Health molecular test was designed for home use to determine if a person is infected with COVID-19.

The Lucira Health molecular test was designed for home use to determine if a person is infected with COVID-19.

Business Wire

There could be a future where you soon take a coronavirus test at home as the Food and Drug Administration granted the first emergency use authorization for an at-home rapid coronavirus test.

What’s going on?

The FDA announced Tuesday that it will grant emergency use for at-home coronavirus testing, which would allow testing to go beyond health care facilities and give people a chance to be diagnosed sooner.

  • However, the test was only approved for prescription use only, which could limit its use.

What’s the test?

The FDA approved a 30-minute test kit from Lucira Health, which is a California developer.

  • The test allows people to swab themselves to collect a nasal sample.
  • The sample is added to a vial that’s put into a portable device, which can read the results and tell someone if they tested positive for COVID-19 or not.
The Lucira Health molecular test was designed for home use to determine if a person is infected with COVID-19.

The Lucira Health molecular test was designed for home use to determine if a person is infected with COVID-19.

Business Wire

Key quote:

  • “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission. Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.” — FDA Commissioner Stephen M. Hahn.

Context:

The news of an at-home test comes as people across the country see COVID-19 spikes and a rise in hospitalizations. This is only the beginning as the United States heads into the winter.