A story that went viral 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.
On Tuesday, it was widely reported that the FDA had approved a serological test to detect the coronavirus. This was potentially significant because having a quick test for the appearance of antibodies could show that somebody has already recovered and developed an immunity to the virus, thus allowing that person to reenter society. This is one of many tools that some public health experts have pointed to as something that could be used to ease up on social distancing restrictions gradually.
The news was reported in a Reuters story that was reprinted by the New York Times, Axios, and many other outlets. The Washington Examiner also reported on the supposed development.
However, when I thought about writing about this breakthrough this morning, a few things struck me as odd.
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.
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.
So then I looked at the FDA webpage announcing Emergency Use Authorizations, and I did not find any reference to the supposed EUA for the BODYSPHERE test.
Finally, I contacted the FDA to ask if any EUA for BODYSPHERE had been issued and received an email back explaining, “No serology tests have received an authorization to test for coronavirus.”
The email went on to explain, “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. 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.”
I left a message at the number at the bottom of the press release, but it went to voicemail, and my call has yet to be returned.
Given today’s date, it seems likely that somebody thought it would be worth exploiting the coronavirus pandemic to pull off an elaborate hoax.
UPDATE: Reuters has since completely withdrawn its story, and the press release has been deleted from the Business Wire website on which it first appeared.
