The FDA has authorized the first over-the-counter (OTC) combination test for Flu and COVID-19, the Healgen Rapid Check COVID-19/Flu A&B Antigen Test, marking a significant step in expanding access to rapid diagnostic testing for respiratory illnesses. This De Novo marketing authorization allows individuals experiencing respiratory symptoms to test themselves at home for both COVID-19 and influenza A and B, with results available in approximately 15 minutes.
The Healgen Rapid Check test utilizes a nasal swab to detect proteins from SARS-CoV-2, influenza A, and influenza B viruses. The authorization is based on data from a study of individuals with signs and symptoms of COVID-19 and influenza. The test demonstrated a sensitivity of 92% and a specificity of 99% for SARS-CoV-2. For influenza A and B, the test correctly identified 99.9% of negative samples, 92.5% of positive influenza A samples, and 90.5% of positive influenza B samples.
Performance and Accuracy
According to the FDA, the test accurately identified 92% of positive COVID-19 cases and demonstrated nearly 100% accuracy for negative flu cases. However, the agency advises users to remain vigilant for potential false positives and to seek medical attention if symptoms persist despite a negative result. As with all rapid antigen tests, there is a risk of false negative results, particularly compared to more sensitive molecular tests.
Michelle Tarver, MD, PhD, acting director of the FDA’s Center for Devices and Radiological Health, stated, "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. Today’s authorization expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home."
Intended Use and Availability
The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is authorized for use by individuals aged 14 years and older who can self-administer the test, or for children aged 2 years and older when the sample is collected and tested by an adult. The test is intended for use within the first five days of symptom onset.
Bingliang Fang, CEO of Healgen, noted, "Our combo test addresses a critical gap in clinical diagnostic testing by providing a reliable and user-friendly solution for individuals to test themselves at home. Early diagnosis enables faster initiation of appropriate treatment, leading to improved health outcomes and reduced disease transmission."
Regulatory Pathway and Future Implications
This De Novo authorization also establishes special controls related to labeling and performance testing, ensuring the safety and effectiveness of similar tests. The FDA’s action creates a new regulatory classification, allowing future combination tests to seek marketing clearance through the 510(k) pathway by demonstrating substantial equivalence to the Healgen device.
Bryan Fang, president of Healgen, added, "This De Novo authorization represents a significant milestone for Healgen. With our existing state-of-art manufacturing facility, we plan to scale up production of our respiratory tests to meet the global demand for the upcoming fall respiratory season."
