On November 17, the US Food and Drug Administration issued an emergency use authorization for the first COVID-19 self-testing kit that gives results within 30 minutes. According to a USFDA press release, the Lucira COVID-19 All-In-One Test Kit was given approval for use in households with a prescription for individuals older than fourteen suspected to have contracted the SARS-coV-2. "This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission," FDA Commissioner Stephen M. Hahn said.
A first of a kind, molecular single-use test for self-diagnosis of the coronavirus, the device manufactured by Lucira Health, Inc. would enable individuals to collect nasal swab specimens on their own, as recommended by a healthcare provider. The test was also authorized for use at the point of care (POC), in the patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The kit can be used by individuals aged below 14 by a healthcare provider at the POC such as the doctor's offices, hospitals, urgent care centers, and emergency rooms. “This test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA in individuals with known or suspected COVID-19,” the company informed.
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. 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, M.D.
“Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
Calling the self-testing kit an important diagnostic advancement, Hahn said, the new testing option can help people address the pandemic at an individual level, thus reducing the burden on the public healthcare facilities that administer the wide-scale testing. meanwhile, the Health and Human Services Secretary Alex Azar said in a statement that Americans being able to test themselves at homes by prescription is the latest addition to the constantly expanding arsenal of COVID-19 testing options. Director of the global health program and senior fellow for global health, economics, and development at the Council on Foreign Relations said that the self-testing kits were a “promising sign” in the pandemic crisis as the US hit 11.4 m overall cases.
“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. 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, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.
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.”
Today, we issued an emergency use authorization (EUA) for the first #COVID19 diagnostic test that allows for self-collection & testing at home and provides test results in 30 minutes or less. The test kit for home use is available by prescription only. https://t.co/EXzSa8JyFR pic.twitter.com/Wooy5YBIbZ— U.S. FDA (@US_FDA) November 18, 2020
According to a statement by FDA Commissioner Stephen Hahn, the COVID-19 diagnostic tests authorized for the home collection are the first that can be fully self-administered and will provide results at home more conveniently without the hassle of driving to the testing centers. An important component to successful at-home testing is the ability to efficiently track and monitor results, the FDA said in a statement. It added that FDA, an agency within the US Department of Health and Human Services, focuses on protecting public health by assuring the safety, effectiveness, and security of human and veterinary drugs.
Individuals are advised to swirl the self-collected sample swab in a vial and then place it in a 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, according to the FDA's release. In case of positive results, the test indicates the presence of SARS-CoV-2 and the individual must then isolate with immediate effect.
Rapid tests could be less accurate than the regular diagnosis for the virus. The US FDA, has, however, outlined that the Lucira Kelly Lewis Brezoczky meets the criteria and may be effective in diagnosing COVID-19. Lucira Health has also developed box labeling, quick-reference instructions, and health care provider instructions to assist with reporting the accurate test results of the coronavirus.