The Food and Drug Administration has decided to change its policy on antibody test reporting and require manufacturers to validate the accuracy of their tests after some unregulated tests have had very high false positive rates.
The new policy was announced Monday and stipulates that companies must apply for an emergency use authorization and include their validation data within 1o days of the product becoming available.
Manufacturers whose tests are already on the market must also submit validation data, and will be reported to the public if they fail to do so, The Hill reported.
Two metrics the FDA will be looking for are specificity, or how often a positive result is achieved; and sensitivity, or how often a correct negative result in achieved, The Hill said.
New standards aim to weed out fraud
Around 200 different antibody tests are now on the market, the Wall Street Journal reported. Going forward, they will have to be at least 90% sensitive and 95% specific.
In March when companies began to produce antibody tests, the FDA allowed companies to self-verify the tests in order to facilitate getting them to market faster, but an investigation by the House Oversight and Reform Committee found that most companies did not self-validate as they were supposed to.
Some developers made false claims about being FDA approved or authorized, and one even claimed that the antibody test could diagnose the coronavirus, which is false. The FDA plans to seize tests coming across the U.S. border that do not meet specifications, the Journal reported.
FDA cracking down
Director of the FDA’s medical-device center Jeffrey Shuren said that criminal investigations into some tests that may be fraudulent are already underway.
“Flexibility never meant we would allow fraud,” the FDA said in a statement. “We unfortunately see unscrupulous actors marketing test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety.”
Members of the White House coronavirus task force have suggested that people should take two antibody tests to ensure accuracy, Politico reported.
In addition, the American Medical Association has been clear that it is not yet known whether having coronavirus antibodies means that a person is immune from being reinfected with the virus. As long as there is a possibility of reinfection, having antibodies doesn’t exempt people from taking the same precautions as they would if they had never been exposed to coronavirus.
People with antibodies should still wash their hands, social distance whenever possible, and wear a mask in public indoors, the AMA cautioned.