WASHINGTON —The FDA issued an emergency use authorization (EUA) for the Lucira Covid-19 All-In-One Test Kit, the first Covid-19 diagnostic test indicated for self-testing at home.
The kit contains a single use, molecular real-time loop mediated amplification reaction test that can be used at-home to detect SARS-CoV-2 in patients 14 years and older with suspected Covid-19. Patients can collect samples via nasal swabs, which are then placed in a vial and inserted into the test unit. Results are available within 30 minutes or less.
“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 a statement.
The FDA noted that the test is also authorized for use in patients of all ages in point-of-care settings such as doctor’s offices, hospitals, urgent care centers, and emergency rooms, but in these settings the samples “must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. The test is currently authorized for prescription use only.” For patients using the test at home, those with positive results are advised to self-isolate and seek additional care from their health care provider — and those with a negative test who still have Covid-like symptoms should follow-up with their health care provider, “as negative results do not preclude an individual from SARS-CoV-2 infection,” the FDA warned.
One requirement of the EUA stipulates that health care providers who prescribe this test are required to report all test results to their relevant public health authorities, “in accordance with local, state and federal requirements,” the agency added. “Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions, and health care provider instructions to assist with reporting.”
John McKenna, Associate Editor, BreakingMED™
Cat ID: 190
Topic ID: 79,190,730,933,190,926,192,927,151,725,928,925,934