FDA Reverses, Manufacturers Must Prove Antibody Test Accuracy

The Food and Drug Administration has reversed its stance and will now require commercial manufacturers to submit data that proves their antibody tests for the coronavirus are accurate.

Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs, and Jeff Shuren, M.D., Director, Center for Devices and Radiological Health announced in a blog post Sunday the FDA has updated the policy that made over 100 antibody tests available on the market without prior review by the agency. The note that the initial policy allowed for "a higher level of flexibility" than is necessary now.

The new policy requires "commercial manufacturers will submit EUA [emergency use authorization] requests, with their validation data, within 10 business days from the date they notified the FDA of their validation testing OR from the date of this policy, whichever is later. Furthermore, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers."

The FDA also announced the agency is "introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests have been made available – one for commercial manufacturers," and one for high-complexity labs that have been certified by the Centers for Medicare and Medicaid Services to conduct testing.

"The FDA will continue to take steps to appropriately balance assurances that an antibody test is accurate and reliable with timely access to such tests as the continually evolving circumstances and public health needs warrant," Shah and Shuren conclude.

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