For immediate release:

Today, the United States Food and Drug Administration cleared the first diagnostic test for home collection of patient samples to detect both COVID-19 and influenza A and B (influenza). The Quest Diagnostics RC COVID-19 + Flu RT-PCR test cleared by the FDA for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 + Influenza by individuals with suspected COVID-compatible respiratory viral infection -19 when home collection is deemed appropriate by an individual’s health care provider. By order of a healthcare provider, patients can collect a home sample and ship it to a Quest Diagnostics lab for analysis by following the instructions provided with the U-Pick Kit.

“Today’s approval for a COVID-19 plus influenza test using home samples is an important step towards the FDA’s national response to COVID-19. With the approval of this test, the FDA is helping fight COVID-19 in the middle of the flu season, which is important to many, including the most vulnerable of Americans. This is another example of the FDA working with test developers to bring important diagnoses to Americans, ”said FDA Commissioner Stephen M. Hahn, MD. used to get answers to Americans faster, from the comfort and relative safety of their own homes, allowing patients to continue to self-quarantine while awaiting results. This efficiency can go a long way in providing timely information to people with unknown respiratory disease. “

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biologicals for human use, and medical devices . The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

###

Related information