The FDA Just Approved Emergency Use of the First 30-Minute Home COVID-19 Test

Samantha Brodsky
·3-min read
Young woman  holds a swab and medical tube for the coronavirus / covid19 home test
Young woman holds a swab and medical tube for the coronavirus / covid19 home test

While the FDA issued the first emergency use authorization (aka, not fully approved) for at-home COVID-19 sample-collecting kits in April, the agency has now approved emergency use of a rapid COVID-19 test done entirely at home - no need to mail your tests out to a lab. The Lucira COVID-19 All-In-One Test Kit consists of a nasal swab and is described as "a molecular (real-time loop mediated amplification reaction)" test by the FDA. It's approved for people 14 years and older who are suspected to have the virus and requires a prescription from a doctor. Results show up in 30 minutes or less.

Here's how it works: you place the provided vial into the battery-powered testing unit, swab your nose (as you do in other nasal COVID-19 tests), stir the swab into the vial, and then cap the vial and press down until you hear a click and the "ready" light starts blinking. After the test is completed - the results will light up as either positive or negative - put it and all of the materials in a plastic bag to throw away.

The FDA says to report your results to your doctor. If the results are positive, the agency advises self-isolation and encourages you to seek additional care. As for those who test negative but still experience symptoms, you should follow up with your doctor.

According to The New York Times, the loop-mediated isothermal amplification reaction (LAMP) of the test detects COVID-19 by repeatedly copying the genetic material found in the virus. LAMP is reportedly faster than a similar lab technique used for many nasal swab COVID-19 tests called polymerase chain reaction (PCR), but LAMP is said to be less accurate (PCR tests are generally accurate).

The Lucira Health website notes that, compared with an FDA-authorized test (that The New York Times reports was a PCR test), the Lucira test was able to accurately detect 94.1 percent of the infections. Note: the test has not been evaluated in people who are asymptomatic.

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This at-home COVID-19 test is also allowed to be used in healthcare settings, and the FDA says that it must be administered by a healthcare provider when children younger than 14 are being tested. According to the test's website, it will cost up to $50.

It's important to note that this doesn't mean you can call your doctor ASAP for a test. A press release states that Lucira's test will be available to patients in two places initially: Sutter Health in Northern California and Cleveland Clinic Florida in the Miami metropolitan area. It is expected to be widely available by next spring. Learn more about Lucira's home COVID-19 test on the Lucira Health website.

POPSUGAR aims to give you the most accurate and up-to-date information about the coronavirus, but details and recommendations about this pandemic may have changed since publication. For the latest information on COVID-19, please check out resources from the WHO, CDC, and local public health departments.