FDA approves first COVID-19 home test 

The U.S. Food and Drug Administration has issued emergency use authorization for the first COVID-19 diagnostic test for self-testing at home.

The Lucira COVID-19 All-In-One Test Kit provides results within 30 minutes, according to the FDA. It has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their healthcare provider. The molecular test is currently authorized for prescription use only. 

It is also authorized for use in point-of-care settings such as doctor's offices, hospitals, urgent care centers and emergency rooms for all ages. 

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 that shows whether a person is positive or negative for the SARS-CoV-2 virus. 

Lucira Health, the test manufacturer, has also developed box labeling, quick reference instructions and provider instructions to assist with reporting.

Individuals with positive results should self-isolate and seek additional care from their provider. Individuals who test negative and experience COVID-like symptoms should follow up with their provider, since negative results do not preclude an individual from SARS-CoV-2 infection, the FDA said.

WHY THIS MATTERS

An important component to at-home testing is the ability to efficiently track and monitor results. 

As noted in the emergency use authorization, prescribing providers are 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. 

Monitoring and tracking the disease is seen as an important method for slowing the spread of the virus.

THE LARGER TREND

Long lines at COVID-19 testing sites and wait times for results have been an issue as the number of cases again surges. 

In the United States, over 11 million cases and 250,000 deaths have been reported.
 
ON THE RECORD

"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 Dr. Stephen M. Hahn.

Health and Human Services Secretary Alex Azar said: "Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options."

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com