This combination test is the first test to be granted FDA De Novo for over-the-counter (OTC) use by the FDA, making this test the first of its kind in combination diagnostic testing for COVID-19, Flu A, and Flu B.

“…our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives. Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home.” – Michelle Tarver, M.D., Ph.D., acting director of the FDA’s Center for Devices and Radiological Health (Click here for FDA Release)

As cases of all three viruses rise and fall yearly, the accessibility of this at-home rapid test plays a significant role in public health. ABC News provided coverage for the authorization of the first over-the-counter combination COVID-19 and flu test outside of emergency use, and also named this test one of the five biggest medical breakthroughs in 2024. The NY Times has also covered this exciting innovation in at-home testing in their article, New Covid Tests Are Here. They Test for Flu, Too.

With this test being the first of its kind to be granted traditional marketing authorization by the FDA, USA Today covered the high demand for this test in their article, and CBS News spoke on the accuracy of this test compared to the emergency use tests in their article. As the need for accurate combination tests increases, so will the production of the tests, as covered in 360Dx’s article, Following FDA De Novo Clearance, Healgen Ramping up Manufacturing of OTC Combo COVID-19/Flu Test. With similar symptoms, this combination test provides clarity for the virus(es)causing the illness, as covered in CNET’s article, Is It COVID or the Flu? Take This FDA-Approved, At-Home Test to Find Out.

This simple nasal swab test allows individuals to quickly determine whether their symptoms are due to COVID-19, Influenza A or Influenza B, eliminating the need for multiple tests and reducing the burden on the healthcare system. The Healgen^® Rapid Check^® COVID-19/Flu A&B Antigen Test is authorized for individuals aged 14 years or older, or for aged 2 years or older when administered by an adult, who are experiencing symptoms within the first five days.

This test has been designed to meet the highest performance standards, including accuracy, reliability, and ease of use, ensuring individuals can trust the results they receive. With rigorous development and validation processes employed to bring the Healgen^® Rapid Check^® COVID-19/Flu A&B Antigen Test to market, the commitment from Healgen Scientific to quality and innovation for improving patient health is evident.

Purchase the Healgen^® Rapid Check^® COVID-19/Flu A&B Antigen Test online today.