FACT CHECK: Did The FDA Authorize This 2-Minute COVID-19 Testing Kit?
An image shared on Facebook claims the Food and Drug Administration (FDA) authorized Bodysphere’s two-minute COVID-19 testing kit.
The FDA has not authorized Bodysphere’s two-minute coronavirus test. Axios and Reuters have retracted their stories about the FDA granting such authorization.
The company Biosphere claimed in a March 31 press release that they had received authorization from the FDA for the first serological coronavirus antibody test, according to CNN. The FDA uses emergency use authorizations (EUAs) to “make available diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies.”
Multiple media outlets, including Reuters, Axios and The Hill, reported on the announcement. (RELATED: Is Amazon Suspending All Deliveries Except For Medical Supplies Due To Coronavirus?)
But the post and Bodysphere’s claim that the FDA granted an EUA for the firm’s COVID-19 test doesn’t hold up. The FDA does not include Bodysphere on its list of in vitro diagnostic EUAs and explicitly refuted that it granted such an authorization.
A spokesperson for the FDA told the Daily Caller in an April 1 email that “no serology tests have received an authorization to test for coronavirus” when asked about Bodysphere’s press release. Since then, several serology tests aimed at detecting the presence of coronavirus antibodies have received EUAs, but none of them come from Bodysphere, according to the FDA website.
“Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection,” the FDA spokesperson explained in an email. “In other words, the test detects the body’s immune response to infection rather than the virus causing the infection. In early days of infection when the body’s immune response is still building, antibodies may not be detected.”
Reuters and Axios retracted their articles reporting on the company’s announcement. Michael Becker, executive vice president of strategic partnerships and initiatives at Business Wire, told the Caller in an email that Business Wire “removed the news from the wire” following “concerns” regarding it.
Bodysphere later told Reuters and CNN that they had not received FDA authorization, with spokesperson D’Anne Mica telling CNN that “there was a misunderstanding.” The company’s CEO, Charlton Lui, also said in a statement that Bodysphere “believed when the manufacturer’s product was listed on the FDA Registry website, that was the Food and Drug Administration’s notification the Emergency Use Authorization was issued.”
The company, which also lists N95 masks, sanitizing gel and hospital beds on its website, claimed to have done its clinical testing with a Zhejiang University-affiliated hospital in China, but a spokesperson for the university denied working with Bodysphere. (RELATED: Did Trump Call The Coronavirus A ‘Hoax’ At His South Carolina Rally?)
“I have confirmed with the affiliated hospitals of our university and got the feedback that they don’t have done (sic) any work with this company,” Zhejiang University spokesperson Ye Ying said in an email to the Caller. “As far as we know, our affiliated hospitals don’t have worked with any American companies on testing kits.”
The Bodysphere website used to showcase photos of the coronavirus test with the words “MADE IN USA” and a FDA logo printed on the box. However, the FDA acknowledgment letter on the Bodysphere website lists the China-based firm Safecare Biotech as the manufacturer.
“The kits are coming from China, so, they’re not coming from China, but the company is, everything, you know, is manufactured in China right now,” Mica told CNN.