The latest test to be authorized by the U.S. Food and Drug Administration (FDA) represents a major milestone amidst the ongoing COVID-19 pandemic: the first combination test capable of detecting both COVID-19 and influenza A and B using samples collected at home.
“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 Hahn said. “This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”
Flu season is beginning, with a healthcare system already taxed to its limits in many places by the ongoing pandemic. As a result, time savers like the Quest Diagnostics test are greatly needed. With a health care provider’s order, the test now allows for patients worrying over infection to take a sample at home and ship it to a Quest Diagnostics lab for further analysis.
This could keep more patients out of already crowded hospitals and doctors’ offices, allowing them to quarantine at home.
The test is for prescription use with the Quest Diagnostics Self-Collection Kit for COVID-19 + Flu. Approval was based on human usability studies on Quest’s COVID-19 home collection kit, as well as existing data on a combo coronavirus-flu test. Still, results could meet with delays. In a statement last month, Quest said the average turnaround for molecular diagnostic tests was two to three days, owing to the surging number of COVID-19 cases. At-home sample collection inherently adds shipping time to that turnaround.