Trust Index: Are at-home COVID-19 tests effective?

Tests are authorized by FDA but not approved

News 6 investigates whether at-home coronavirus tests are accurate.
News 6 investigates whether at-home coronavirus tests are accurate.

ORLANDO, Fla. – In the fight against the coronavirus pandemic, testing is essential.

But what about at-home tests? They are available but are they effective?

There are a number of companies making at-home tests for COVID-19, but it’s important to note the tests are authorized by the Food and Drug Administration, but not approved by the FDA -- and there is a difference.

Since the coronavirus hit Florida in March, we have seen numerous drive-up testing sites pop up across Central Florida, across the state and across the country.

Testing has become more prevalent and even at-home tests are now available.

Dr. Robert Mordkin is the chief medical officer for Let’s Get Checked, a home diagnostics company.

“We have put a laser focus on bringing COVID testing as widely available as possible,” Mordkin said.

Lets Get Checked is one one of eight companies currently authorized by the FDA to offer at-home COVID-19 tests.

“We were very happy to achieve from the FDA authorization for home use,” Mordkin said

Everlywell, Picture by Fulgent Genetics, Pixel by LabCorp, Vitagene, Vault, Hims & Hers, and Phosphorus are authorized as well.

The FDA issued its first emergency use authorization for at-home tests in April.

“For tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site,” FDA Commissioner Stephen M. Hahn, M.D., wrote in a press release.

Mordkin said their test is simple to administer.

"We've got a very, very valid test on our hands and one that can be done by an individual and by themselves."

Dr. Nicole Iovine is an epidemiologist at UF Health in Gainesville.

“I believe that the intention for those (at-home tests) are for people who are not going to go to a doctor’s office or could not,” Iovine said.

Be Careful

After reviewing this topic, we've found some issues - Be Careful.

What is the Trust Index?

She noted that the testing process is complicated.

”The thing about the home tests is that there’s a lot of things that have to go right in order for that test to be accurate,” Iovine said

All of the companies claim their tests are accurate.

Home tests have to be properly packaged and shipped to the lab in a timely manner, Iovine said

She also said getting a good sample can be difficult for consumers.

But Mordkin said because their test is a lower nasal swab, it does not have to be administered by a medical professional.

At home tests cost between $109-$155 and all but one of the companies want payment up front.

Pixel by Lab Corp will bill your insurance, or will try and recoup payment from the government for the uninsured.

Iovine believes self tests should be for those who cannot go to a doctor.

"If a person becomes sick, the best thing really is to talk to your doctor about getting the gold standard test," she said.

Because home tests have been given FDA authorization and not full FDA approval, we give them “be careful” on the Trust Index.

FDA authorization means COVID-19 home tests can be used during the public health crisis.

But they are not FDA approved, which means they have not been put through the rigorous review the agency normally requires.

About the Author:

Emmy Award-winning reporter Louis Bolden joined the News 6 team in September of 2001 and hasn't gotten a moment's rest since. Louis has been a General Assignment Reporter for News 6 and Weekend Morning Anchor. He joined the Special Projects/Investigative Unit in 2014.