The Food and Drug Administration denied that it has approved any serology tests, even in an emergency fashion, for the coronavirus.
A press release posted Tuesday online from a supposed company called Bodysphere Inc. claimed it had received emergency approval from the FDA for a new kind of testing kit that would allow patients to receive results in as few as two minutes.
But an FDA representative told the Washington Examiner‘s Philip Klein on Wednesday: “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,” the representative said. “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 statement added: “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.”
A request for comment left in a voicemail with the phone number listed on the press release was not immediately returned.
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Editor’s note: This story has been updated to reflect the FDA denied approving any serological tests that can detect the coronavirus.
