For the first time, patients at suspected risk of COVID-19 can test themselves at home and see results within 30 minutes.
The FDA issued the EUA to Lucira Health, Inc. for its molecular single-use COVID-19 All-in-One Test Kit that is intended to detect the SARS-CoV-2 virus and can do so within 30 minutes; a positive test result can be generated in as few as 11 minutes.
“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,” said Jeff Shuren, MD, JD, director, Center for Devices and Radiological Health, FDA, in the agency’s November 17, 2020 press release. “Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them.”
The test kit contains the palm-sized test device, sample vial, and a swab; patients simply swirl the self-collected nasal swab in the vial that is then placed in the test unit. After about 30 minutes, the results are displayed on the test unit’s light-up display.
Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them.
The diagnostic test – initially developed as an influenza test kit – is authorized for home use with self-collected nasal swap samples in persons aged ≥14 years who are suspected of COVID-19 by their health care provider.
The test is also authorized for use in point-in-care (POC) settings, such as hospitals and urgent care centers, for all ages but samples must be collected by a health care provider when the test is used at the POC to test persons aged <14 years. The test is currently authorized for prescription use only.
When the test was compared with “one of the most reliable FDA authorized high sensitivity SARS-CoV-2 assays available,” it achieved a 94% positive percent agreement and a 98% negative percent agreement, according to a Lucira Health press release.
Furthermore, the test achieved 100% positive percent agreement when researchers excluded samples with low levels of SARS-CoV-2 that may not reflect active infection, the company noted in the press release.
The EUA also requires prescribing health care providers to report all test results they receive from individuals who use the test to their relevant public health authorities in accordance with local, state, and federal mandates.
“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, MD, in the agency’s press release.