FDA Approves First COVID-19 Self-Testing Kit, Promises Results At-Home in 30 Minutes

The United States is still hitting record numbers for positive coronavirus cases. Today, a new effort to control the pandemic has moved the Food and Drug Administration (FDA) to make an emergency authorization for at-home testing.

What We Know:

  • According to the FDA, Lucira is a COVID-19 all-in-one test kit that uses self-collected nasal swab samples that can be used by suspected COVID-19 patients. The single-use test can be purchased with a prescription for self-diagnosis of COVID-19 and is authorized for at-home use for those over the age of 14.
  • It is a rapid test that can provide results in 30 minutes using a form of molecular amplification technology to identify the virus in patients suspected of being infected. The test kit includes a sterile swab, a sample vial, a test unit, batteries, and a plastic disposal bag. Unlike other at-home tests, Lucira is the first self-administered test that can provide results at home using a light-up display to show whether the patient is positive or negative for COVID-19. 
  • It is also authorized for medical practices like doctor’s offices, hospitals, urgent care centers, and emergency rooms. However, the samples must be collected by a healthcare provider when the test is used on children younger than 14 years old.
  • In a statement for CNN, Health and Human Services Secretary Alex Azar approved of the FDA’s actions stating, “Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options.”

With the FDA making strides to expand rapid testing across the nation and companies racing to approve a vaccine, we can only hope that this pandemic will meet its end sooner rather than later.

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