Many of the tests that are available are giving false-positives, which means that some people who have not been exposed to COVID-19 are under the impression they have been.
At the beginning of April, the U.S. Food and Drug Administration (FDA) approved the first antibody test for COVID-19. Since then, the regulatory agency has allowed more than 100 antibody tests onto the market without full review and that has proven to become a problem as some tests are not as accurate as hoped.
Many of the tests that are available are giving false-positives, which means that some people who have not been exposed to COVID-19 are under the impression they have been. And that can be a frightening thing as the United States begins to re-open some businesses in hopes of kick-starting the economy that was shut down due to the pandemic. Antibody testing has been seen as a positive reassurance for people who will begin to mingle in public again as businesses begin to re-open their doors. Although there is not yet evidence of protection against COVID-19 from previous exposures, there is hope that it will be the case as it has often been in the past. This weekend the World Health Organization issued a statement that the presence of antibodies does not necessarily prevent re-infection from the disease. WHO said there is no evidence as of yet to support this.
Inaccurate tests are proving to be a concern and the FDA is bearing the brunt of criticism for allowing so many tests onto the market without properly vetting them. Last week, the House Oversight Committee released a report on antibody testing that said “numerous companies appear to be marketing fraudulent tests” — and that the FDA had “failed to police the coronavirus serological antibody test market,” Politico reported. The House committee recommended shutting the antibody marketplace down until procedures are improved, CNN said.
Stephen Hahn, the recently-approved FDA Commissioner, told Politico that the FDA had given leeway to so many antibody tests due to the pandemic. Hahn said the regulatory agency is now looking at changing its policy that allows for the tests to be marketed as long as there is a disclaimer with the results. Earlier this month, the FDA told healthcare providers of its concerns around the plethora of antibody tests. The agency said it “does not review the validation, or accuracy, data for these tests unless an EUA (Emergency Use Authorization) is submitted.” EAU provides confidence in a test, Hahn told Politico.
The FDA has provided EAU to seven antibody tests, including that of N.C.-based Cellex, which was the first-to-market. Ortho Clinical Diagnostics and Abbott have also received EAU for their serology tests. There are others awaiting approval, including Roche’s Elecsys Anti-SARS-CoV-2 serology test, which could receive EAU in the next few weeks.
Hahn told CNN that the agency will take appropriate action against companies that distribute unvalidated tests or make false claims. He said the FDA will use its authority to stop such promotions and also seek to detain any fraudulent test kits that may come across the border.
“FDA will continue to consider the risks and benefits of our policies as the emergency evolves and adjust as necessary. FDA is constantly evaluating whether our policy needs to change based on new information to protect the public health,” the FDA said in a statement to CNN.
