Cleveland Clinic Assists With First At-Home COVID-19 Test Approved By FDA!

FEATURED PHOTO: DR. GARY PROCOP, VIROLOGIST, By Lisa Ryan, Posted November 27th 2020

You may soon be able to test yourself for COVID-19 and get results in your home within 30 minutes.

The U.S. Food and Drug Administration issued an emergency use authorization for the test, making it the first fully at-home test for the coronavirus to receive FDA approval.

The Lucira Health test requires a prescription, and people need to show symptoms of COVID-19 infection to be prescribed the test by their physician.

Dr. Gary Procop, a virologist at the Cleveland Clinic, assisted with accuracy studies for the test. It has the potential to help keep sick people at home, and preserve personal protective equipment, or PPE, Procop said.

“If they went to a swabbing station, the nurse or caregiver would have to gown, glove, put the mask on, in order to take a nasal swab specimen,” he said. “Here we can save all that PPE because the person’s doing it for themselves, in their home.”

When used correctly, on people who are showing signs and symptoms of COVID, it is as accurate as other tests, Procop said

In one study, the test had a 94.1 percent accuracy for positive tests. Procop said.  

The people who had false negatives had lower viral loads, meaning the virus was exiting their systems. That means the test is best used on a person who is showing symptoms, and within 5 days of those symptoms developing, he said.

False positives are very rare in any test, according to Procop, but more likely in an antigen test, the other form of testing. 

This test is molecular, and it tests for nucleic acids, like laboratory tests, Procop said. 

People using the test will swab both sides of their nose, put the swab in a vial, stir it around and wait for their results, which should take no more than 30 minutes. A light will come on showing whether the test is positive, negative, or invalid.

Some doctors may choose to give patients this test because it can be done in the doctor’s office and the patient can receive results before he or she leaves, he said.

The company will roll out the home-based test in California and Florida initially, and it may take until the spring of 2021 for wider availability.

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