FDA Gives Approval For First COVID Home Test

Whereas testing has grown to be more available since the coronavirus first started taking the country by storm back in March of this year, it’s now going to be much more accessible, and get this, available from the comfort of your own home.

The Food and Drug Administration (FDA) has approved the very first COVID-19 test that can be taken at home.

On Tuesday, officials allowed emergency use of the first rapid COVID-19 test that can be performed from home. The announcement by the FDA is an important step in US efforts to increase testing options for the Chinese virus beyond healthcare facilities and testing sites.

The COVID-19 All-In-One Test Kit, made by Lucira Health, is done by a self-collected nasal swab, which is then put right into a sample vial. Customers will be able to see their test results on a display screen in 30 minutes or less, according to the FDA’s news release.

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

“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,” said FDA Commissioner Dr. Stephen M. Hahn. “This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission.”

Close to 300 coronavirus tests have been approved by the FDA thus far, the vast majority of which have to be administered at a testing site before being shipped to a lab for processing. A few allow the nasal swab or saliva sample to be collected in your home, however, those tests nonetheless have to be sent to a lab and people often have to wait days for the results.

This game-changing form of testing will enable for quick and easy results with no risk of transmitting the virus at a doctors office or testing site.

The emergency use authorization issued by the FDA at present only allows the at-home test to be given via prescription to individuals 14 and older. It can be used at hospitals, doctors offices, urgent care facilities, and coronavirus testing sites for all ages, however, the sample must be collected by a healthcare provider.

Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said, “Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19,” adding, “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.”

Although a recent series of positive news from Moderna Inc and Pfizer Inc on their forthcoming vaccines has increased hopes in combating the disease, thanks to the diligent efforts of President Donald Trump and his administration, testing still is a key factor in controlling the spread of the virus.  Trump doesn’t get any recognition from the Democrats, the media, and some partisan folks in the medical industry, but he mobilized the most impressive force to combat this pandemic than any other past administration in our nation’s history.

It’s really despicable to hear the Trump haters blame the president for every death that occurs from the virus, especially since federal dollars were included in the stimulus packages written by the Schemer of the House Nancy Pelosi that gives more money to hospitals that deal with COVID-19 patients, the idea being that the medical people need to take higher precautions, so they get money to pay for the PPE that’s needed.  But that has allegedly caused many hospitals around the country to list patients who have died as being the result of having coronavirus, and it’s been reported that in some cases the patient never had the virus or did, but died from some other underlying condition like heart disease.

“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,” Shuren added. “We look forward to proactively working with test developers to support the availability of more at-home test options.”