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# Covid/Flu Rapid Test Authorized for OTC Use
- URL: https://www.fdaweb.com/covid-flu-rapid-test-authorized-for-otc-use/
- Published: 2024-10-08T12:00:00.000Z
- Updated: 2026-09-14T14:43:24.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157939

FDA has granted a *de novo* marketing authorization to Healgen for its over-the-counter Healgen Rapid Check Covid-19/Flu A&B Antigen Test. The test, which is intended for use by individuals experiencing respiratory symptoms, uses a nasal swab sample to deliver at-home results in about 15 minutes, according to an FDA [news release](https://content.govdelivery.com/accounts/USFDA/bulletins/3ba905d?ref=fdaweb.com). It detects proteins from both SARS-CoV-2 and influenza A and B, it says.

The authorization was based on data from a study of individuals with signs and symptoms of Covid-19 and influenza, “which showed that this test correctly identified 99% of negative and 92% of positive SARS-CoV-2 samples, 99.9% of negative Flu A and B samples, and 92.5% and 90.5% of positive Flu A and Flu B samples, respectively,” FDA says. “As with all rapid antigen tests, which generally have lower sensitivity than molecular tests, there is a risk of false negative test results. Individuals who test negative and continue to experience symptoms of fever, cough and/or shortness of breath may still have SARS-CoV-2, flu or another respiratory infection and should seek follow up care with their health care provider."