Thinking of buying an at-home coronvirus test? Think again, FDA warns Americans
Americans wanting to know if they are infected with COVID-19 can buy at-home tests for $99 up to $150, but the Food and Drug Administration warns those kits are risky for reasons that include possible exposure to toxic samples.
There is no such thing as an FDA approved at-home test for the coronavirus as of April 15, in spite of what a some companies advertise, the agency said in a Tuesday alert.
This includes cases where a company promises a specialist will assist sample taking via live video chat, the FDA says.
“At this time, the FDA has not authorized any COVID-19 test for at-home testing, including self-collection of a specimen with or without the use of telemedicine,” the FDA says
“The FDA is supportive of at-home testing for COVID-19, provided there is data and science to support consumer safety and test accuracy.”
COVID-19 is blamed for infecting about 2 million people globally and killing more than 128,000, based on data released early Wednesday by Johns Hopkins University.
FDA officials did not cite examples of companies offering at-home tests without proper authorization.
However, companies such as VaultHealth.com sell “medically-supervised telehealth testing in your home” for COVID-19 at a cost of $150. The company says the “physician-ordered” saliva test is available for people experiencing symptoms to get tested without leaving their home.
“The approved collection device allows a Vault medical practitioner to supervise the saliva sample collection over a video call with you,” the company says on its website.
ABC News reported this week that VaultHealth’s production of the at-home kit is based on “a controversial interpretation of FDA regulations regarding at-home testing versus testing in a ‘clinical environment’.”
Another company, MicroGenDx, says on its Website that it will provide home sampling test kits directly to patients at home if a physician has “signed off on a Provider Service Agreement.”
FDA officials say they’re “actively working with developers toward the goal of authorizing EUAs (emergency use authorizations) for home use tests,” but just aren’t there yet.
Among the sticking points, the FDA says, is the accuracy of home-collected samples and the safety of transporting potentially “toxic” material to a lab.
“Home collection raises several issues of importance, including whether the lay user can safely and properly collect the specimen, whether the components of the specimen transport media are safe...and the potential impact of shipping conditions, such as if the specimen sits in a hot truck,” the FDA said.
“A physician watching the collection by way of telemedicine may address the issue of proper specimen collection ..., but it does not address the other issues, and specimen stability and shipping conditions are still of concern,” the release said.
This story was originally published April 15, 2020 at 7:25 AM with the headline "Thinking of buying an at-home coronvirus test? Think again, FDA warns Americans."