Editorial office. Peninsula 360 Press [P360P]
The U.S. Food and Drug Administration (FDA) issued an emergency use authorization for the first COVID-19 diagnostic test for self-diagnosis at home that provides rapid results.
The Lucira COVID-19 All-in-One Test Kit, approved Tuesday, is a single-use molecular test that is intended to detect the new SARS-CoV-2 coronavirus that causes COVID-19.
"While there are diagnostic tests for COVID-19 that have been approved for home collection, this is the first test that can be done entirely and provide results at home," said FDA Commissioner Stephen M. Hahn, M.D. "We are pleased to be able to offer this service.
He added that this new testing option is an important diagnostic breakthrough to address the pandemic and reduce the public burden of disease transmission.
The test kit has been licensed for home use with a sample that can be collected by the user with nasal swabs from persons over 14 years of age who are suspected by their health care provider to have the virus.
The agency said in a statement that the all-in-one kit is also authorized for use in care site facilities such as doctors' offices, hospitals, urgent care clinics and emergency rooms for all ages.
However, he said that a health care provider must collect the samples when the test is used for people under 14.
Currently, the test is authorized for prescription use only, he said.
The test works by spinning the swab with your self-collected sample into a vial which is then placed into the test unit, and within 30 minutes or less, the results can be read directly from the illuminated display of the test unit, where it can be read whether a person is SARS-CoV-2 positive or negative.
The FDA said that people who test positive should isolate themselves and seek additional care from their health care provider, while those who test negative and experience symptoms similar to those of COVID-19 should consult their doctor, since negative results do not rule out a person having a SARS-CoV-2 infection.
"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," said Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health.
"We look forward to working proactively with test developers to support the availability of more home testing options," he said.
As stated in the emergency authorization, health care providers who prescribe the kit must report all test results they receive from test users to the appropriate public health authorities in accordance with local, state, and federal requirements.
Lucira Health, the manufacturer of the test, has also developed box labels, quick reference instructions, and instructions for the physician to more effectively generate his or her reports.
