COVID-19 antibody testing met with scrutiny in suburbs, Illinois

As for-profit labs began offering COVID-19 antibody testing seemingly overnight, the backlash against the practice from medical researchers and government officials was almost as swift.

Unprompted at his daily coronavirus briefing late last week, Illinois Gov. J.B. Pritzker advised residents that "there are still no antibody blood tests certifiably proven to accurately and consistently diagnose COVID-19 antibodies." He warned test results could give someone a "false sense of security" about chances of getting the the disease.

The tests are intended to check for previous COVID-19 infection, with the idea that it might confer immunity.

U.S. Rep. Raja Krishnamoorthi, a Democrat from Schaumburg who heads the House Oversight Committee's Subcommittee on Economic and Consumer Policy, released a detailed report on the subcommittee's antibody testing investigation Monday and condemned the U.S. Food and Drug Administration for relaxing guidelines that normally would have prevented the tests from going to market. "Emergency Use Authorizations" were granted to some test makers by the FDA to get the tests on the market quickly, without standard validation processes.

"I was shocked to learn that we do not have the ability to know whether the available serology tests work and the FDA has no plans to make that a reality," Krishnamoorthi said. "They have put the public's health at risk by allowing inaccurate and potentially fraudulent tests to spread unchecked."

One company, ARCpoint Labs, is offering tests ranging from $65 to $175 that advertise someone who tests positive for the antibodies is "likely to be immune" and a candidate to "return to work." The company, which is based in South Carolina, has labs in Schaumburg, Libertyville and Orland Park. Its claims are being investigated by Krishnamoorthi's subcommittee, which warned company officials about the language in its advertising.

"Looking at this website, their statement ... may not be permitted as it overstates what we know about immunity," said Krishnamoorthi spokesman Wilson Baldwin.

ARCpoint officials said they believe they are complying with all requirements set by the federal government. However, they acknowledge the tests have shortcomings.

"Though antibody tests strive to be as 'specific' as possible, the tests cannot guarantee the positive results are not due to past or present infections," said ARCpoint CEO and President John Constantine. "This is one of the required disclaimers that all antibody testing results must include."

Constantine added that the tests ARCpoint offers are manufactured by a company that is still waiting for FDA approval for emergency use, but "these tests are still FDA-compliant under the March 16 Policy for Diagnostic Testing."

Meanwhile, medical researchers have begun rapidly examining the legitimacy of antibody tests and found troubling results. One study based at the University of California at San Francisco found several that gave false positives more than 10% of the time. In normal trials, tests that had more than 2% failure rates would not be allowed to market, researchers told CNN.

Illinois Attorney General Kwame Raoul's office did not respond to multiple requests for comment about the tests.

However, a spokeswoman for Pritzker said the governor plans to make sure the public is aware of the shortcomings of the tests.

"We are advising the public to be aware of what they are buying," said Jordan Abudayyeh. "Until these antibody tests show adequate reliability the state won't support their use."