20 November 2020 - Deborah Wilkes
The US Food and Drug Administration (FDA) has authorised the first COVID-19 test that can be “fully self-administered and provide results at home”.
The FDA issued an emergency use authorisation (EUA) for Lucira Health’s COVID-19 All-In-One Test Kit, which is a molecular single-use test. The regulatory agency noted the test was currently authorised for prescription use only.
Lucira said the test would be available on a “limited basis” in “the near future” to patients served by Sutter Health in Northern California and by Cleveland Clinic Florida in the Miami-Fort Lauderdale area. The company added that it should be available nationally through healthcare providers by “early spring 2021”.
The company anticipates its test will cost around USD50.00.
The FDA said the test had been authorised for “home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their healthcare provider”. The test is also authorised for use in point-of-care settings such as doctor’s offices and hospitals.
FDA commissioner Stephen Hahn said the new testing option was an “important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission”.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said a “test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic”.
Swab, stir and detect
Lucira commented that its test had a “simple swab, stir and detect design”. The company added that “clinical trials showed 100% of patients were successfully able to perform the Lucira test in about two minutes”.
The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit's light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus.
The FDA pointed out that the ability to track and monitor results efficiently was an important component of successful at-home testing. The EUA states that prescribing healthcare providers are required to report all test results they receive to their relevant public health authorities.