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FDA Authorizes First Over-the-Counter Combination Flu and COVID-19 Test

• The FDA has granted marketing authorization to the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, the first over-the-counter combination test for flu and COVID-19. • This test is authorized for self-use by individuals 14 years and older with respiratory symptoms and for children aged 2-13 when administered by an adult. • The Healgen test uses a nasal swab to detect SARS-CoV-2, influenza A, and influenza B, providing results in approximately 15 minutes. • Clinical data showed the test accurately identified 92% of positive SARS-CoV-2 samples, 92.5% of positive flu A samples, and 90.5% of positive flu B samples.

The U.S. Food and Drug Administration (FDA) has authorized the marketing of the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, marking the first over-the-counter (OTC) combination test for both influenza and COVID-19 to receive such approval outside of emergency use authorization. This authorization, granted on October 7, 2024, signifies a step forward in accessible at-home diagnostics for respiratory illnesses.
The Healgen test is designed for self-administration by individuals aged 14 years and older who are experiencing respiratory symptoms. For children between the ages of 2 and 13, the test can be administered by an adult. The test utilizes a nasal swab sample to detect the presence of proteins from SARS-CoV-2, influenza A, and influenza B viruses, which are responsible for causing COVID-19 and seasonal influenza, respectively. The results are available in approximately 15 minutes, facilitating rapid decision-making regarding isolation and treatment.

Performance Data

According to data submitted to the FDA, the Healgen test demonstrated high accuracy in identifying negative samples for both SARS-CoV-2 and influenza. The test correctly identified 99% of negative SARS-CoV-2 samples and 99.9% of negative influenza A and B samples. In positive sample detection, the test accurately identified 92% of SARS-CoV-2, 92.5% of influenza A, and 90.5% of influenza B samples.

Considerations for Use

The FDA has noted that, similar to other rapid antigen tests, there is a risk of false negative results, particularly when viral loads are low. The agency advises that individuals who test negative but continue to experience symptoms, as well as those who test positive, should consult with their healthcare provider for further guidance and management. This recommendation aligns with standard medical practice, ensuring appropriate follow-up and care.
This authorization reflects the FDA's ongoing efforts to support the development and availability of convenient and reliable at-home diagnostic tools, empowering individuals to proactively manage their health and reduce the spread of respiratory infections.
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Reference News

[1]
FDA Authorizes Marketing for First Combination Flu and COVID-19 At-Home Test Outside of ...
akingump.com · Nov 8, 2024

On Oct 7, 2024, FDA authorized marketing of Healgen Rapid Check COVID-19/Flu A&B Antigen Test, the first over-the-counte...

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