SILVER SPRING, Md.—The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that provides rapid results for self-testing at home. Lucira Health, Inc.’s COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test intended to detect SARS-CoV-2.
“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,” said FDA Commissioner Stephen M. Hahn, M.D. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”
The Lucira COVID-19 test kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected to have COVID-19 by their health care provider. The test has also been authorized for use in point-of-care (POC) settings for all ages, but samples must be collected by a healthcare provider when the test is used for those younger than 14. It is currently authorized only for prescription use.
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. Positive results indicate the presence of SARS-CoV-2. Lucira notes that individuals who test negative yet experience COVID-like symptoms should follow up with their health care provider, as negative results do not preclude an individual from SARS-CoV-2 infection.
“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. 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,” added Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
Efficiently tracking and monitoring results is an important component to successful at-home testing. As noted in the EUA, prescribing health care providers will be required 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 requirements. Lucira Health has also developed box labeling, quick reference instructions and health care provider instructions to assist with reporting.
“There are currently two types of COVID-19 tests that detect whether a person is infected and potentially infectious. Antigen tests detect viral proteins and can provide results quickly,” explained Erik Engelson, chief executive officer of Lucira Health, in a press release. “However, they are not diagnostically definitive and are more likely to miss an active coronavirus infection, or positive result, compared to molecular tests. Molecular tests like Lucira’s are 50 to 60 times more sensitive than antigen tests, and considered the ‘gold standard’ for determining if someone is infected.”
To validate the test for the FDA, more than 100 people from a broad range of ages, ethnicities and education levels were enrolled in Lucira’s Community Testing Study in northern and southern California, including the San Francisco Bay area. Based on the trial’s design, patients suspected of having COVID-19 tested themselves outside their homes, under the observation of trained professionals. The trial reported that 100% of the individuals were able to successfully run the test.
Lucira test results were compared with one of the most reliable FDA authorized high sensitivity SARSCoV-2 assays available. The comparative positive results agreed 94.1% of the time across all samples, and 100% of the time excluding samples containing very low levels of virus (at or below 37.5 Ct). The negative results agreed 98.0% of the time across all samples.
Lucira also has an ongoing clinical trial with the Cleveland Clinic Florida.
“Immediate, on-site testing will improve patient care and throughput in urgent care environments,” noted Dr. James Roach, emergency department chair and a principal investigator for Lucira’s trial at the Cleveland Clinic Florida. “This test will allow patients to isolate at home while waiting for results with faster turnaround.”
”Being able to quickly determine if a person is infected or not has been a global problem,” concluded Dr. John Chou, physician with the Palo Alto Foundation Medical Group and a principal investigator of the study submitted to the FDA. “We believe this highly mobile test can make a big difference by providing lab-quality results expeditiously and conveniently.”