First FDA Approved Covid-19 At-Home Testing Kit


By Celina Saba, Staff Writer

Getting tested for Covid-19 these past few months has been a struggle. According to Medical News Today, “It can take anything from a few hours to several days to receive COVID-19 test results.” Also, those who need to be tested for Covid-19 may also be required to leave quarantine to visit a medical professional.

However, on Tuesday, Nov. 17, Lucira Health’s “All-in-One” test kit became the first FDA authorized rapid at-home Covid-19 test. The test is estimated to sell for less than $50 and is currently approved for prescription use only.

According to The Washington Post, “Unlike rapid antigen tests, which experts warn can be unreliable, the kit will test genetic material in a method similar to the laboratory tests that have become the standard for detecting the virus. After swirling the nasal specimen into a solution, home-testers plug the vial into a portable, battery-operated device, which uses a light to indicate the test result within 30 minutes. A positive test result can be generated in as few as 11 minutes.”

Once a result is generated, the FDA requires the health professionals who prescribe the test to report the test results from the patients according to local, state, and federal requirements.

According to the U.S. Food and Drug Administration, “Individuals with positive results should self-isolate and seek additional care from their health care provider. Individuals who test negative and experience COVID-like symptoms should follow up with their health care provider as negative results do not preclude an individual from SARS-CoV-2 infection.”

The test, however, won’t be on the national market until Lucira increases its production rate. For now, they are aiming to be available “in the near future” for patients in Northern California’s Sutter Health and South Florida’s Cleveland Clinic. Their goal is to be on the national market by early spring 2021.

Overall, the authorization of a complete at-home test is momentous. Now, with a test that can be completely administered without a lab or a healthcare environment, more people who may have Covid-19 can have their results almost instantly and the ability to immediately protect themselves and those around them.