CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Dec. 7, 2020—The FDA authorized the first diagnostic test for at-home collection of patient samples to detect COVID-19 and influenza A and B. Quest Diagnostics’ RC COVID-19 +Flu RT-PCR Test for prescription use was authorized with Quest’s 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 a health care provider.
“With just one swab or sample, combination tests that are authorized for use with home-collected samples can be used to get answers to Americans faster, in the comfort and relative safety of their home, which allows patients to continue to quarantine while awaiting results,” FDA Commissioner Stephen M. Hahn, MD, said in a statement from the agency. “This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”