The FDA is tightening oversight of antibody tests after the agency learned some testmakers made false claims about the blood tests.
The Food and Drug Administration announced plans Monday to bolster oversight of antibody tests by requiring commercial testmakers to meet new standards of accuracy and submit information proving the testing quality.
The agency reversed its March 16 policy that allowed antibody testmakers to sell their products without the normal step of sharing data with the agency to validate accuracy.
The agency said commercial testmakers will have 10 business days to submit data and seek the agency's emergency use authorization. The agency will recommend testmakers meet accuracy, or "sensitivity and specificity," thresholds as part of the tighter oversight.
Public health experts questioned the precision of antibody tests deployed in communities nationwide. Public heath officials warned that elected officials, business leaders and consumers should be careful about making decisions based on antibody test results.
Association of Public Health Laboratories CEO Scott Becker, who was critical of the FDA's initial policy, said the agency made the right decision.
“We’ve long been concerned that allowing tests on the market that have not been approved and authorized for use is a recipe for disaster," Becker said. "This revised policy makes a lot of sense and should have been in place over the last six weeks."
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 Jeffrey 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.
Large community antibody testing projects from New York to California aim to more accurately reflect how many people have been infected with the virus that causes COVID-19. The tests might reveal whether someone develops immunity that protects from infections, but scientists are unclear whether that immunity is temporary or long-lasting.
On April 24, 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 testmakers 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 had to include disclaimers about the tests.
The FDA officials said some companies falsely claimed their antibody tests were approved or authorized. Others 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 that "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 National Institutes of Health.
The FDA has reviewed and authorized 12 antibody tests for emergency use.
To evaluate other antibody tests being marketed, the FDA teamed up with the National Cancer Institute, the National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention.
The FDA said the National Cancer Institute evaluated and shared data on 13 test kits. The FDA said it will publicly report the data once it's been reviewed.
The data can be used to authorize the tests or ask the testing company for more information to continue marketing the tests. The agency can order the companies to discontinue selling tests that performed poorly.
The FDA said it will publicly share information on companies that sell tests without seeking emergency use authorization within 10 business days. If companies seek to import illegally marketed tests, the FDA will detain those kits and bar entry into the USA. Several Chinese companies notified the United States of plans to sell tests under the March 16 policy.
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Peter Pitts, a former FDA associate commissioner and co-founder of the Center for Medicine in the Public Interest, said the FDA's action shows the agency is responding quickly to an unprecedented public health crisis.
For example, the agency authorized doctors to use Strategic National Stockpile-donated supplies of the malaria drug hydroxychloroquine on COVID-19 patients. When reports emerged about heart rhythm problems associated with the drug, the agency issued a safety alert.
"Desperate times require creative regulatory measures," Pitts said. "The only goals here are advancing public health and saving lives."
SEARCHABLE MAP: Coronavirus death rates and cases for every US county: https://interactives.courier-journal.com/projects/cv19/map/
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