|February 12, 2021
NEJM: The FDA’s Experience with Covid-19 Antibody Tests
Jeffrey Shuren, M.D., J.D., and Timothy Stenzel, M.D., Ph.D. from the Food and Drug Administration (FDA) review the process, procedures, and challenges related to evaluating test performance and authorizing products—specifically antibody tests—early in the pandemic. Their conclusion: “Moving forward, the FDA will continue to take steps to ensure the timely availability of accurate and reliable antibody tests to meet the public health need as the pandemic evolves.”
First, our experience with serology tests underscores the importance of authorizing medical products independently, on the basis of sound science, and not permitting market entry of tests without authorization.
Second, the federal government should coordinate the preparation of a public–private research plan to address epidemiologic questions regarding disease spread and immunity at the beginning of an outbreak as part of its preparedness plan.
Third, we should establish the capacity within or on behalf of the federal government to evaluate test performance before outbreaks occur so that independent evaluation can be performed quickly during an outbreak.
Fourth, the scientific and medical communities should understand the purpose and clinical use of serology tests and how to appropriately use test results in general to inform patient care.
Finally, all parties involved in public health emergency response need better information more quickly.
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