Editor. Peninsula 360 Press [P360P].
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization for the first COVID-19 diagnostic test for self-testing at home that provides rapid results.
The all-in-one Lucira COVID-19 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 COVID-19 diagnostic tests that have been cleared for home specimen collection, this is the first test that can be done completely and provide results at home," said FDA Commissioner Dr. Stephen M. Hahn.
He added that this new testing option is an important diagnostic advance to address the pandemic and reduce the public burden of disease transmission.
The test kit has been licensed for home use with a user-collectable sample that can be collected with nasal swabs from people 14 years of age and older who are suspected by their health care provider of having the virus.
The agency said in a statement that the all-in-one kit is also cleared for use in the facilities of care sites such as doctors' offices, hospitals, urgent care clinics and emergency rooms for all ages.
However, she said a health care provider must collect the samples when the test is used for people younger than 14.
The test is currently 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 COVID-19-like symptoms should consult their doctor, as negative results do not rule out that a person has 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 Jeff Shuren, M.D., 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 in-home testing options," he stressed.
As indicated in the emergency authorization, health care providers prescribing the kit must report all test results they receive from persons using the test 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 reports.
