It’s April Fool’s Day, and along with all the other misinformation going around about the coronavirus, one story made its way through the media Wednesday morning before it had a chance to be fact-checked.
As my former editor at The Washington Examiner, Phil Klein, wrote, the viral story about the Food and Drug Administration “approving a two-minute test for coronavirus antibodies looks like a cruel hoax timed to coincide with April Fools’ Day.”
Klein wrote that he became suspicious when he started to consider writing about the alleged breakthrough, even though the story had already been reported by Reuters and reprinted in The New York Times, Axios, and elsewhere.
“All of the stories eventually led back to a press release issued by a company calling itself BODYSPHERE Inc. I’ve never heard of any such company, and all Google searches just referenced the story about the coronavirus test,” Klein wrote. “I then checked out the website of the company, and the only products listed were a COVID-19 test, medical masks, and hand sanitizer — all products that happen to be in high demand right now. The company’s Twitter page had no tweets before Monday.”
Klein said he then searched the FDA website for Emergency Use Authorizations and found none referring to the BODYSPHERE test. The kicker came when Klein reached out to the FDA itself, which responded by saying “No serology tests have received an authorization to test for coronavirus.”
“Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection. 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. This limits the test’s effectiveness for diagnosis,” the FDA said in its email response. “Given their limited use and the fact that serology tests are less complex than molecular tests, the FDA is not objecting to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated, notification is provided to FDA, and appropriate statements are included with the test reports, for example, noting the test has not been reviewed by the FDA and that results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. This approach provides flexibility for developers, with appropriate transparency regarding the limitations of such tests.”
The news of an alleged two-minute test for antibodies came on the heels of an announcement from the FDA that a new COVID-19 test kit would be available within the next month and could return a positive test in as little as five minutes and a negative test in as little as 13 minutes. The new test, from Abbott Laboratories, was announced during a Rose Garden briefing on Monday by FDA Commissioner Dr. Stephen Hahn. The announcement was part of Trump’s coronavirus task force briefing.