FDA Approves First At-Home COVID-19 and Flu Test Without Prescription
The Healgen Rapid Check test allows individuals to detect both viruses from home, enhancing personal health management during flu season.
- The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is the first over-the-counter test for both COVID-19 and flu, approved by the FDA without the need for a prescription.
- The test uses a nasal swab to detect proteins from SARS-CoV-2 and influenza A and B, providing results in approximately 15 minutes.
- Individuals aged 14 and older can self-administer the test, while children aged 2 and older require adult assistance.
- FDA data indicates the test correctly identifies 99% of negative and 92% of positive COVID-19 samples, and over 90% accuracy for positive flu samples.
- Healgen plans to make the test available for purchase by Thanksgiving through retailers like Amazon and CVS, aiming to meet demand during the respiratory virus season.