Coronavirus antibody tests arrive in greater Cleveland as medical experts warn of ‘false sense of security’

Coronavirus antibody tests arrive as medical experts warn of “false sense of security"

CLEVELAND, Ohio (WOIO) - A medical diagnostics company with several locations in northeast Ohio is now offering COVID-19 antibody testing.

Quest Diagnostics, headquartered in New Jersey, announced last week that it is conducting blood tests to detect antibodies of the virus, using tests developed by Abbott and EUROIMMUN.

The company has four locations in the immediate Cleveland area, with several more throughout Northeast Ohio.

“Antibodies developed by the body in response to a viral infection may provide potential immunity against future infection,” the company said in a news release.

But some medical experts aren’t as quick to adopt that theory.

“A lot of these tests haven’t really been fully validated,” said Dr. Kamran Kadkhoda of the Cleveland Clinic. “Now there’s a flurry of these tests flooding the market just because there is opportunity.”

In a letter to health care providers earlier this month, the U.S. Food and Drug Administration (FDA) wrote:

“The FDA is not aware of an antibody test that has been validated for diagnosis of SARS-CoV-2 infection. While the FDA remains open to receiving submissions for these tests for such uses, based on the underlying scientific principles of antibody tests, the FDA does not expect that an antibody test can be shown to definitively diagnose or exclude SARS-CoV-2 infection.”
FDA, April 17

The agency, however, is recommending providers continue with testing.

“It is too soon,” said Dr. Kadkhoda. “The mere having a positive [antibody] result may be erroneously interpreted as a false sense or security, immunity or relaxation of criteria.”

“From a mere scientific or clinical perspective, we don’t really know what that means,” he told 19 News.

On Friday, the World Health Organization (WHO) also urged caution.

“There is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection,” the agency said.

White House Coronavirus Task Force Coordinator Dr. Deborah Birx was asked about the WHO’s position on Sunday.

“WHO is being very cautious,” she said on CNN’s State of the Union. “I think what WHO was saying [is] we don’t know how long that effective antibody lasts and I think that is a question we have to explore.”

The Better Business Bureau of Greater Cleveland is also watching closely. The group has been warning patients for weeks to follow the medical guidance and be on the lookout for scams.

“Anytime we have a fear like this, and uncertainty, we’re isolated and financially impacted, our lives are turned upside down, we’re desperately searching for answers,” said chapter president Sue McConnell. “People are more vulnerable to all kinds of scams.”

She pointed to the possibility of scammers asking victims for personal information while promising medical care and testing.

McConnell also urged patients to consult the FDA’s online database for antibody updates, which currently reveals the agency has not yet validated a single lab or manufacturer to offer tests through what’s known as an Emergency Use Authorization (EUA).

Quest Diagnostics said its primary test platform developed by Abbott, received EUA by the FDA on Sunday.

“Quest has performed and reported results of approximately 75,000 COVID-19 antibody tests. We are now able to perform more than 150,000 antibody tests a day, or about 1 million a week,” the company said in an email to 19 News Monday evening.

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