NORFOLK, Va. — As people across the U.S. seek a return to normal life, COVID-19 antibody tests have emerged throughout the country.
An effective antibody or serological test will tell a person if they've had a previous infection with the virus. If the test comes back positive, the patient has antibodies.
But some health officials are sounding the alarm about their lack of reliability.
Dr. Edward Oldfield, a Professor of Medicine at Eastern Virginia Medical School, said many of the tests currently on the market are delivering inaccurate or false-positive results.
“I think we’re really in dangerous waters right now with these antibody tests and giving out a lot of false information,” said Oldfield. “Companies are making claims for a nearly perfect test. I don’t believe that. They also are not doing any testing related to cross-reacting antibodies with other coronaviruses. They can be giving false information on the one side, a false-positive. You think you’ve been infected, and you really haven’t. You think you’re immune and you’re not.”
Right now, the Food and Drug Administration’s website states there are no FDA-approved antibody tests currently on the market. The FDA’s website lists only nine COVID-19 serological tests have been granted Emergency Use Authorization. But Oldfield said the process of validating those tests was rushed.
In a disclaimer, the FDA warns current tests on the market have limitations.
Dr. Oldfield says with inaccurate tests, people could end up with false-positive results.
“I am not recommending that anybody get tested with the current tests. There are all kinds of scams out there. There are people that last week they were selling windows, and this week they’ve gone on the website in China, purchased a test, and claim now they’re the middleman distributor for this test,” said Oldfield.
Under the FDA’s current regulations, anyone who wants to sell an antibody test in the U.S. can do so by disclosing that they’re not FDA approved on their packaging and going through a process of validation with the FDA.
Oldfield said the validation process is faulty, adding the unregulated market for the tests creates a perfect storm for tests to appear valid, when in reality, they may not be.
“We need validated tests. We need to validate them not only for how good they are, but we need to know whether they’re cross-reactive with those coronaviruses that cause the common cold,” said Oldfield.
His advice? If you were thinking about getting an antibody test, hold off for now.