NEW YORK – The US Food and Drug Administration late Tuesday evening granted Emergency Use Authorization to the first COVID-19 assay for rapid self-testing at home, the Lucira COVID-19 All-in-One Test Kit from Lucira Health.
The single-use test uses real-time loop-mediated isothermal amplification, a PCR alternative that operates at ambient temperatures, to detect SARS-CoV-2 RNA in patients with known or suspected COVID-19. The assay runs on a handheld battery-powered device that returns results in 30 minutes or less via an LED readout.
The FDA granted EUA to Lucira's test for prescription home use with self-collected nasal swab specimens in individuals age 14 years and older who are suspected of COVID-19 by their healthcare provider. The FDA also granted EUA for use of the test at the point of care in CLIA-waived settings such as doctor's offices, hospitals, urgent care centers, and emergency rooms. In these situations, samples must be collected by a healthcare provider when the test is administered to individuals younger than 14 years.
Individuals who receive a positive test readout should self-isolate and seek additional care from their healthcare provider, while individuals who test negative but are still experiencing COVID-19-like symptoms should self-isolate and seek additional care from their provider, since negative results do not preclude the possibility of SARS-CoV-2 infection, the FDA said. Prescribing healthcare providers are required to report all test results they receive from individuals who use the test to relevant public health authorities in accordance with local, state, and federal requirements.
According to an FDA fact sheet, in a community testing study the Lucira test was compared to an FDA-authorized SARS-CoV-2 test with known high sensitivity, and achieved 94 percent sensitivity and 98 percent specificity.
In a statement, Lucira said that the kit is expected to be available to patients served by Sutter Health in Northern California and Cleveland Clinic Florida in Miami/Fort Lauderdale in the near future. The test is expected to be available nationally by early spring 2021. Lucira added that it is "committed to making at-home testing accessible and anticipates its test will cost around $50."
The FDA has previously authorized COVID-19 diagnostic tests for at-home sample collection, but this is the first test to receive EUA for full at-home testing — a "significant step toward FDA's nationwide response to COVID-19," Jeff Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement.
"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," Shuren said. "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. We look forward to proactively working with test developers to support the availability of more at-home test options."
Emeryville, California-based Lucira Health has been developing at-home molecular testing for infectious diseases for several years. Formerly called Diassess, the company has previously received funding from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) as part of a cost-share contract to develop a rapid molecular flu test for home use.
Last year, former BARDA Director Rick Bright (recently named to US President-elect Joe Biden's COVID-19 advisory team) cited Lucira in an interview as one of two companies the agency was heavily investing in for at-home diagnostic test development.