"As we enter this year's annual flu season with respiratory illnesses such as COVID-19 on many of our minds, our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives," said Dr. Michelle Tarver, acting director of the FDA's Center for Devices and Radiological Health. Her statement emphasizes the importance of being able to test for both diseases easily at home.
"The Healgen test is the first combined home COVID and flu test authorized to be marketed outside emergency use," highlighting its significance in facilitating home testing and potentially improving public health responses during flu seasons.
"The at-home test results for both COVID-19 and flu appear in approximately 15 minutes, which allows individuals to gain insights into their health quickly without the need for a professional visit," underlining the convenience and efficiency of the new testing option for families.
"As with all rapid antigen tests, which generally have lower sensitivity than molecular tests, there is a risk of false negative test results," suggesting caution regarding the reliability of the findings, and encouraging confirmation through more sensitive testing if necessary.
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