FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test

T-Detect COVID Test is another tool for health care providers to help identify if a person had a COVID-19 infection in the past

If your email program has trouble displaying this email, view as a webpage. COVID-19 Update: FDA Authorizes Another Tool to Identify if a Person Had a Previous COVID-19 Infection  Today, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Adaptive Biotechnologies for its T-Detect COVID Test. The T-Detect COVID Test: Analyzes DNA from a patient's T cells (white blood cells) to aid in identifying people with an adaptive T cell immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection. Should be used together with a clinical examination and a patient's medical history. Negative results do not rule out acute or current SARS-CoV-2 infection. Should not be used to diagnose current SARS-CoV-2 infection. Is authorized for use in laboratories designated by Adaptive Biotechnologies Corporation that meet requirements to perform high-complexity tests. Read More Questions? If you have questions, contact the Division of Industry and Consumer Education.

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