COVID-19 Update: FDA Issues First Emergency Use Authorization for a COVID-19 and Flu Combination Test for Use with Home-Collected Samples
Today, the U.S. Food and Drug Administration (FDA) authorized the first diagnostic test for use with home- collected patient samples to detect both COVID-19 and influenza A and B (flu).The FDA authorized Quest Diagnostics RC COVID-19 +Flu RT-PCR Test for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 +Flu by individuals who are suspected of respiratory viral infection consistent with COVID-19 when home collection is determined to be appropriate by an individual’s healthcare provider.
Under a health care provider’s order, patients can self-collect a nasal sample at home and then ship it to Quest Diagnostics for analysis, using the instructions in the collection kit.
Questions?
If you have questions, contact the Division of Industry and Consumer Education.
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