Devices

EUA Templates to Speed Serology Tests: FDA

To improve FDA’s emergency use authorization (EUA) for Covid-19 serology (antibody) tests, the agency says it is working on EUA templates that laboratories and commercial manufacturers may use to facilitate the preparation and submission of such requests. The serology tests will likely play a huge role in identifying individuals who have overcome an infection in the past and have developed an immune response. The agency believes they could also be used to help identify, together with other clinical data, individuals who are no longer susceptible to infection and can return to work.

In a 3/18 post by FDA commissioner Stephen Hahn, the agency is continuing to allow interested developers to request FDA authorization through the EUA process, and so far four EUAs for serological tests have been granted. He said FDA is collaborating with the National Institutes of Health’s National Cancer Institute, National Institute of Allergy and Infectious Diseases and the Centers for Disease Control and Prevention to “establish a capability at NIH to evaluate serological tests for developers. This effort includes tests already available for use, as well as tests not yet on the market where additional validation data is needed to support an EUA. Performance assessments for serological tests will begin soon, and we expect to start seeing results shortly thereafter. We will review NIH’s results expeditiously, and performance results from NIH’s assessment may complement and inform the determination of whether FDA issues an EUA for a particular test.”

Hahn said that all clinical tests should be validated prior to use. “We have provided regulatory flexibility regarding the independent check by FDA for antibody tests that are limited in their clinical applications, but still expect all developers to validate their tests prior to offering them for limited clinical uses,” he said. To reduce the number of false positive results, serological tests must be “well-designed to specifically identify antibodies” against Covid-19 and must not “cross-react,” or provide positive results when encountering antibodies against other respiratory viruses.

Currently, FDA is working to provide more clarity about which tests have received FDA review and which have not. “We have also updated our Web site to better clarify which tests have been authorized by FDA and which have not been authorized,” he said. “However, some test developers have misused the serology test kit notification list to falsely claim their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose Covid-19. When we become aware of these issues, we have and will continue to take appropriate action .... such as issuing Warning Letters requesting that companies stop their unlawful promotion and detaining and refusing fraudulent test kits at the border.”

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