United States: The US Food and Drug Administration cleared the first at-home, over-the-counter, COVID-19 and flu test that is not an emergency use product on Monday evening.
More about the news
This simply means that you do not need a doctor’s prescription to purchase the Healgen Rapid Check COVID/Flu A&B Antigen Test.
The FDA stated it clear that the test is for individuals who present with respiratory ailments. The novel combination of COVID-19 and flu test outside of emergency use on Monday evening.
The new combination test uses an ‘antigen test’ for COVID-19 and flu based on a nasal swab sample and can yield results in about 15 minutes at home.
More about the test
Healgen’s test identifies antigens from SARS-CoV-2, which causes COVID-19, and two types of the flu, A and B.
According to Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, “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,” ABC News reported.
“Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home,” Tarver added.
“The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions,” he continued.
What more are the experts stating?
According to the federal health agency, anyone who is 14 or older is to have the test on their own, as well as those two or older who would have a sample taken by an adult.
Results showing that the test was able to provide 99 percent accuracy for negative COVID samples and 92 percent for positive samples were reviewed by the FDA.
Further, a specificity of 99.9 percent for the negative flu samples and sensitivities of 92.5 percent and 90.5 percent for the positive flu samples were achievable within the test, ABC News reported.
Similar to other OTC at-home COVID-19 antigen tests, the FDA stated a positive test result may indicate a patient is positive, while a negative rest may need a second confirmation test.