The Food and Drug Administration on Monday announced plans to bolster oversight of antibody tests by requiring commercial test makers to meet new standards of accuracy and submit new information proving the testing quality.
The new policy is a reversal of the agency's March 16 policy that allowed antibody test makers to to sell their products without the normal step of sharing data with the agency to validate test accuracy.
The agency said commercial test makers will have 10 business days to submit new data and seek the agency's emergency use authorization. The agency also will require test makers to meet accuracy, or "sensitivity and specificity" standards, as part of the tighter oversight.
The tightened policy comes after public health experts questioned the precision of antibody tests now being deployed in communities nationwide. Public heath officials, warned elected officials, business leaders and consumers should be careful about making decisions based on antibody test results.
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The FDA's initial policy that allowed test developers to validate their own data "never meant we would allow fraud," according to a statement from Deputy Commissioner for Medical and Scientific Affairs Anand Shah and Director of the Center for Devices and Radiological Health Jeff Shuren,
"We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety," the statement said.
Also called serology tests, these blood tests are designed to detect whether a person has developed antibodies to fend off SARS-CoV-2, the virus that causes COVID-19. The tests are different from the molecular “PCR” tests used to diagnose COVID-19.
Last month, the World Health Organization warned against issuing "immunity passports" to people who believe they are safe based on positive antibody tests. In a statement, the WHO said there’s no evidence those who recover from COVID-19 and develop antibodies will be immune from a follow-up infection.
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More than 200 test makers have notified the FDA of plans to market antibody tests under the agency's March 16 policy. The companies or labs were allowed to market the tests if they validated their own data and notified the FDA, but they were not allowed to claim the FDA authorized the tests and must include disclaimers about the test.
The FDA officials said some companies falsely claimed their antibody tests were approved or authorized. Others also claimed the tests could diagnose COVID-19 or could be used at home, neither of which are allowed under the agency's policy.
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The agency said it is aware of "a concerning number of commercial serology tests are being promoted inappropriately, including for diagnostic use, or are performing poorly based on an independent evaluation," conducted by the the National Institutes of Health.
The FDA has reviewed and authorized 12 antibody tests for emergency use.
For other antibody tests now being marketed, the FDA has teamed up with the National Cancer Institute, National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention to evaluate those tests.
The FDA said the National Cancer Institute has evaluated and shared data on 13 test kits the agency has reviewed so far. The FDA said it will publicly report the data once the agency has reviewed.
The data can be used to authorize the tests or ask the testing company for more information to continue marketing the tests, officials said. For tests that have performed poorly, the agency can order the companies to discontinue selling the tests.
This is a developing story. Check back for updates.