Therapy Areas
FDA Authorizes First COVID-19 and Flu Combination Test for Use with Home-Collected Samples
4 December 2020 - - The US Food and Drug Administration authorized the first diagnostic test for at home collection of patient samples to detect both COVID-19 and influenza A and B, the agency said.

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 collect a sample at home and ship it to a Quest Diagnostics laboratory for analysis following the instructions included with the self-collection kit.

The FDA, an agency within the US Department of Health and Human Services, assures the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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