TAMPA, Fla. — This story is the latest installment in our YouTube series, "What's Brewing,” investigative reporter Jenna Bourne's series of homemade deep dives into important issues during the coronavirus pandemic. Click here to check out the series and subscribe to our YouTube channel: The Deeper Dive.
To be allowed back on campus after winter break, University of Virginia student Jessica Terry told 10 Investigates she had to use a COVID-19 test kit that was authorized for at-home collection by the FDA.
“I, like, ran and drove to a UPS store as fast as I could and delivered it that way. And then it took about, like, I think two days for me to get my test results back,” Terry said.
The FDA has given dozens of at-home COVID-19 test kits Emergency Use Authorization.
Three are home tests, where you collect your sample and get your results at home on the same day.
More than 40 are home collection kits, like the kind Terry used, where you collect a specimen at home, then ship it off to a lab to get your results.
“They have really thorough instructions. It is basic stuff. You just stick something in your nose. I think it’s really well how they do lay out the instructions. So, it’s like, you can’t mess it up. Which I really enjoy because I am very much a person who messes things up a lot,” Terry said.
Lisa Bari, who works in public health, said at-home tests are more appealing than waiting in line at a drive-through testing site.
“At this point I’ve done, I want to say, four at-home COVID tests,” Bari said. “I don’t have to go anywhere. I don’t have to see anyone. I don’t have to put anyone else at risk to actually take a PCR test, the gold standard test for determining whether you’ve had a coronavirus infection, at-home.”
But 10 Investigates found the government has busted dozens of businesses trying to sell unapproved coronavirus test kits for at-home use, including two businesses in Tampa Bay.
The FDA tells us it’s issued 18 warning letters for violations related to at-home COVID tests or collection kits -- businesses trying to sell test kits that don’t have FDA authorization for at-home use.
A spokesperson for the Federal Trade Commission tells 10 Investigates that agency has also gotten about 25 complaints related to unapproved COVID tests.
Dr. Jill Roberts, an associate professor of environmental health who specializes in emerging diseases at the University of South Florida College of Public Health, said the results of unapproved COVID tests can be wrong.
“The risk to public health is huge because we can have people that are out there, who actually think that they don’t have COVID, but they do. And, so, they’re running around in the community,” Roberts said.
The Florida Attorney General’s Office told 10 Investigates, last year, it caught two Tampa Bay area businesses trying to sell COVID-19 test kits that had not gotten the green light from the FDA for at-home use.
We reached out to Streamline RX LLC in Clearwater and PrecisionMed Pharmacy in Tampa. Neither wanted to do an interview, but they both told us it was a mistake based on bad info from their suppliers.
They both said no unapproved tests actually made it into the hands of consumers and they refunded everyone who tried to buy the kits.
Documentation from the AG’s Office showed both businesses also paid $5,000 in civil penalties.
So, why does it matter if a kit hasn’t gotten FDA Emergency Use Authorization as an at-home test?
“There are two major factors there. And the one side of it is to make sure that it’s correct, right? So, the results that it gives are actually accurate. When it’s positive, it’s positive. When it’s negative, it’s negative,” Roberts said. “The other piece we don’t think about a lot is the manufacturing. So, the FDA is in charge of making sure those products are manufactured safely. So, can you imagine -- what happens if you take a nasal swab and stick that thing up into your nasal pharynx and it’s not sterile?
“You could infect somebody by actually doing that. You can actually create problems if that swab is made of non-approved products. So, what if it’s got glass? What if it’s got wood?”
Well, that doesn’t sound fun. So, how do you know if your test kit is legit?
The FDA has all the tests that got Emergency Use Authorization posted on its website. Type the name of the test you want in the search box. The “Attributes” and “Authorized Settings” columns will show you if it’s approved for at-home use.
If you suspect a COVID-19 test kit is fraudulent, report it to the FDA by emailing FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.
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