FDA authorizes 1st fully at-home COVID-19 test

    Sign outside the FDA headquarters.

    (Image: © Shutterstock)

    The Food and Drug Administration (FDA) has authorized the first fully at-home rapid COVID-19 test.

    The test, made by Lucira Health in California, requires a prescription and provides results within 30 minutes, according to a statement from the FDA.

    Although the FDA has authorized hundreds of COVID-19 tests (including at-home tests), these earlier tests either needed to be administered by a health care provider or sent to a lab for analysis.

    The new test “is the first that can be fully self-administered and provide results at home,” FDA Commissioner Dr. Stephen Hahn, said in the statement. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”

    Related: 20 of the worst epidemics and pandemics in history 

    To use the test, people first swab themselves inside both nostrils. To get a good swab, people should tilt their head back and insert the swab tip fully inside the nostril, until they meet resistance, according to instructions from Lucira. The company says the test should not hurt, but may sometimes feel uncomfortable or tickly. After swabbing, users place the swab in a vial and swirl it around. The vial is then placed in a battery-powered device with a light-up display. After a half hour, the display lights show if the person has tested positive or negative.

    People should report their results to their health care providers, who are then required to report all test results to public health authorities, the statement said.

    The test is authorized for home use in people ages 14 and older who are suspected to have COVID-19, the FDA said. In children younger than 14, a health care provider must administer the test.

    According to Lucira, a study of the test’s accuracy found that it correctly identified 94% of people with the virus, and correctly ruled out infection in 98% of healthy people. 

    The test detects genetic material from SARS-CoV-2, the virus that causes COVID-19, through a method known as loop mediated amplification reaction, or LAMP. This method is similar to PCR, the gold-standard for COVID-19 testing; however, LAMP is generally considered less accurate than PCR, according to The New York Times.

    Lucira anticipates that each test will cost about $50, according to a statement from the company. The test should be available in the near future to patients in Northern California served by Sutter Health, and to patients of the Cleveland Clinic Florida in Miami-Ft. Lauderdale, the statement said. The company expects the test to be available nationally by early spring 2021.

    Originally published on Live Science.  

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