FDA’s Revised Policy Tightens Requirements for COVID-19 Antibody Tests

The US Food and Drug Administration {(FDA) Silver Spring, MD, USA} has updated its policy on antibody tests for COVID-19 from March 16, 2020, tightening the requirements for such tests.

During the time when the FDA had issued its March 16 policy, a higher level of flexibility was appropriate for antibody tests than for molecular tests that detect the presence of the virus that causes COVID-19, since antibody tests are not meant for use to diagnose active SARS-CoV-2 infection. This flexibility in the FDA’s March 16 policy allowed for early use of antibody tests to begin to answer critical population-level questions about the prevalence of COVID-19 infections in different communities, and whether the presence of antibodies conveys immunity, and, if so, for how long.

However, the FDA continues to adapt based on real-world experience and data and so, as it has authorized more antibody tests and validation data have become available, the careful balancing of risks and benefits has shifted from where it was in mid-March. Therefore, the FDA has made an important change to its March 16 policy regarding the FDA review for commercial manufacturers’ serology tests. Under the revised policy, the FDA now requires commercial manufacturers of antibody tests to submit emergency use authorization (EUA) 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.

High-complexity laboratories developing their own tests, also called Laboratory Developed Tests or LDTs, must still have a CLIA certificate (provided by CMS) to legally develop a serology test. In addition, under the policy outlined by the FDA, they are performing their own validation and providing notification to the FDA, as well as following other labeling recommendations described in the March 16 policy. Developers of LDTs are still encouraged to seek authorization through an EUA.

In addition to updating the policy, the FDA has introduced 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 CLIA certified high-complexity labs who decide to seek FDA authorization. These templates will facilitate the preparation and submission of an EUA request and can be used by any interested developer.

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US Food and Drug Administration