Quest Diagnostics received the US Food and Drug Administration (FDA) authorisation for RC Covid-19 +Flu RT-PCR Test for prescription use with the company’s self-collection Kit to detect both Covid-19 and Flu.
The US-based clinical laboratory claimed that its RC Covid-19 +Flu RT-PCR Test is the first diagnostic test to be authorised for at home collection of patient samples to detect both Covid-19 and influenza A and B (flu).
FDA Commissioner Stephen M Hahn said: “Today’s authorization for a Covid-19 plus flu test using samples collected at home is a significant step toward FDA’s nationwide response to Covid-19.
“With the authorization of this test, the FDA is helping to address the ongoing fight against Covid-19 while in the middle of the flu season, which is important for many, including the most vulnerable of Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans.
Quest Diagnostics tests home-collected samples for Covid-19 and Flu
The FDA authorisation facilitates the at-home Covid-19 and Flu testing in individuals suspected of respiratory viral infection consistent with Covid-19, if home collection is determined by the individual’s healthcare provider.
With the health care provider’s recommendation, patients can collect the samples at home, following the instructions included with the self-collection kit, and ship it to a Quest Diagnostics laboratory for analysis.
Hahn added: “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.
“This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”
In July, Quest Diagnostics has granted emergency use authorisation (EUA) by the FDA for its new laboratory method to increase the Covid-19 molecular diagnostics capacity.
