FDA authorizes test to detect recent or prior infection with SARS-CoV-2

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FDA authorizes test to detect recent or prior infection with SARS-CoV-2
tjordan_drupal
Mar 9, 2021

The Food and Drug Administration Friday issued an emergency use authorization for a next generation sequencing test to aid in identifying individuals with an adaptive T cell immune response indicating recent or prior infection with SARS-CoV-2. 

Health care providers may order the test for patients at least 15 days after symptom onset.

Testing is currently limited to laboratories designated by Adaptive Biotechnologies Corporation that are certified under the Clinical Laboratory Improvement Amendments and meet the requirements to perform high complexity tests. For more information, see the factsheet for health care providers.

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FDA authorizes test to detect recent or prior infection with SARS-CoV-2
tjordan_drupal
Mar 9, 2021

The Food and Drug Administration Friday issued an emergency use authorization for a next generation sequencing test to aid in identifying individuals with an adaptive T cell immune response indicating recent or prior infection with SARS-CoV-2. 

Health care providers may order the test for patients at least 15 days after symptom onset.

Testing is currently limited to laboratories designated by Adaptive Biotechnologies Corporation that are certified under the Clinical Laboratory Improvement Amendments and meet the requirements to perform high complexity tests. For more information, see the factsheet for health care providers.

COVID-19: CDC, FDA and CMS Guidance

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