In the previous policy issued on March 16, 2020, FDA stated that the agency “does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2” if the test is validated, a notification is provided to FDA, and certain disclosure information is included in the test report or device labeling. FDA, however, did not require entities following the “notification pathway” to seek Emergency Use Authorization (EUA) for these serology tests, although several manufacturers did obtain EUA approvals for serology tests. To date, more than 100 serology tests have been marketed under this “notification pathway.” In the revised policy, however, FDA now asks all commercial manufacturers of serology tests to submit an EUA request with validation data within “10 business days from the date of notification or the date of publication of” the updated policy, whichever is later.
Consistent with FDA’s original approach, the revised policy continues to clarify that until an EUA is authorized to allow the test to be used in other settings, use of the serology test is limited to “laboratories certified to perform high complexity testing, and at the point-of-care when covered by the laboratory’s CLIA certificate for high-complexity testing.” Note that for serology tests developed by CLIA certified high-complexity laboratories, rather than commercial in vitro diagnostic manufacturers, can be used by such laboratories under FDA enforcement discretion. Such tests must still be validated, notification must be provided to FDA, and specific labeling restriction information must be included in the test reports.
In addition, FDA has included in the revised policy two EUA templates for serology tests: one for commercial manufacturers, and one for CLIA certified high-complexity laboratories. Notably, FDA provided specific performance threshold recommendations for specificity and sensitivity for all serology tests.
The revised policy reflects FDA’s heightened scrutiny of serology tests for SARS-CoV-2, which is part of agency’s response to the recently reported findings of fraudulent test kits and test kits with inferior performance.
Authored by Randy Prebula, Dr. Erkang Ai, Michael Heyl, and Susan Tiedy-Stevenson