WASHINGTON — QUESTION:
What should consumers know about at-home COVID-19 testing kits?
ANSWER:
Some require a prescription, however some do not. After the sample is collected at home, some kits must be shipped to and processed by a lab however some kits are completely processed at home.
SOURCE:
PROCESS:
A viewer named Brian emailed the Verify team and said he was getting at home COVID-19 testing kit offers and he asked to look into what he should know about them.
The Food and Drug Administration is the agency responsible for regulating products like these, and our source for this story.
According to the FDA, you should only use a kit that has been given Emergency Use Authorization by the agency. If you don't, “You will risk unknowingly spreading COVID-19 or not getting treated appropriately if you use an unauthorized test.”
Since the start of the pandemic, the FDA has given EUA to more than 225 diagnostic kits for COVID-19.
So how do you know if an at-home COVID-19 testing kit is FDA authorized?
They’re all listed on the FDA’s webpage.
The majority of the kits are by prescription only, so after one is prescribed and shipped to you, you collect the sample at home, ship it back to a lab and wait for the results.
The FDA authorized 3 at home testing kits that are processed fully at home and give you results in minutes.
The Lucira COVID 19 All In One Test Kit and BinaxNOW COVID-19 Ag Card home test which are available by prescription only.
The Ellume Covid 19 Home Test kit is over the counter so you don’t need a prescription from a healthcare provider.
The Pixel Kit by LabCorp is for those 18+ years old. It's FDA authorized and it's available without a prescription but it has to be sent back to and process by LabCorp.
LabCorp says on its webpage it’s "reserving access to COVID-19 at-home kits for individuals experiencing symptoms or those who have been asked to get tested."
The other kit that does not require a prescription is the Ellume COVID-19 home test kit. It's suitable for ages 2+ and it's fully processed at home with results in about 15 minutes.
If you still have questions about these kits, the FDA says to protect yourself by talking with your doctor and turn to reliable government sources like the FDA, the Centers for Disease Control, the Department of Health and Human Services, and the National Institutes of Health for answers.
You can report suspected fraudulent COVID-19 related products to the FDA’s Office of Criminal Investigations