Fraud Antibody Testing For COVID-19: FDA Mandates Submission of Quality Data Before Commercial Sales To Curb Inaccuracy

The U.S. Food and Drug Administration (FDA) announced on Monday that now it is mandatory for commercial sellers offering antibody testing for COVID-19 to submit information providing the quality of tests and conform to the new standards before the test is commercially available.

With the announcement, the federal body reversed its own decision to allow the commercial manufacturers and suppliers of antibody testing for COVID-19 to sell their kits without submitting data related to accuracy.

The initial announcement, which took place on March 16, gave a higher level of flexibility and was an attempt to ensure easy availability and understand test performance. However, this seems to have led to a fraudulent market, the FDA believes.

"Flexibility never meant we would allow fraud. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety," said FDA in its announcement.

The new guidelines released further adds that the test makers can seek emergency use authorization for antibody testing for COVID-19 but will have to submit the data related to testing and accuracy as per the norms and safety standards within 10 days to the FDA.

The sensitivity, as well as specificity of the test, will be checked in an attempt to have tighter control over the accuracy of antibody testing for COVID-19 available in the U.S.

The FDA’s attempt to firm its grip on antibody test kit manufacturers has come after reports of inaccuracy, which may further deepen the coronavirus crisis in the country.

The public health experts in the country have long questioned the accuracy and have even advised the business leaders, politicians and consumers to be careful and not base their decision based on the test results they see as they cannot be relied upon.

FDA’s new regulations concerning the accuracy of antibody testing for COVID-19 may help to improve the situation to some extent.

“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," said Scott Becker, SEO of the Association of Public Health Laboratories. "This revised policy makes a lot of sense and should have been in place over the last six weeks."