Influenza Treatment Updates

FDA Approves First Covid-19, Flu Test With Home-collected Samples

By Adam Hochron
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The FDA has authorized the use of the first diagnostic test for COVID-19 and flu that can have the samples collected at a patient’s home. 

The Quest Diagnostics RC COVID-19 + Flu RT-PCR test was authorized for prescription use with the Quest Diagnostics Self-Collection Kit for Covid-19 + Flu for patients suspected of having COVID-19 when a provider prescribes home collection. According to a release from the manufacturer, the sample is collected at a patient’s home and then sent to a Quest Diagnostics lab for further analysis. 

“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,” said FDA Commissioner Stephen M. Hahn, MD. “With the authorization of this test, the FDA is helping to address the ongoing fight against COVID-19 while in the middle of flu season, which is important for many, including the most vulnerable of Americans.” 

As the COVID-19 virus has spread around the world, concerns were raised about the impact of cold and flu season as both conditions’ symptoms can appear similar without specific testing. Hahn said by having this test available, patients can provide the samples from their homes and stay safely quarantined from the rest of the community while waiting for their results. 

“This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment,” Hahn added.

According to Quest’s website, the company has conducted more than 25 million COVID-19 molecular tests in the past nine months. The company noted in that time they have increased their testing capacity from one lab in California to more than 20 facilities across the country.