Loading...

The first home flu and COVID-19 combination test is approved for marketing by the FDA outside of emergency use authorities

October 18, 2024

Marketing permission for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test was given by the U.S. Food and Drug Administration. The test is approved for use without a prescription and is intended for those with respiratory symptoms. It takes a nasal swab sample and provides at-home results for COVID-19 and influenza (flu) in about 15 minutes. Both influenza A and influenza B (the viruses that cause the flu) and SARS-CoV-2 (the virus that causes COVID-19) proteins are detected by the test.

This is the first over-the-counter (OTC) test that can detect influenza to be granted marketing authorization using a traditional premarket review pathway, which enables the test to be marketed in the absence of an applicable emergency use declaration. Other OTC flu/COVID tests are currently available under emergency use authorization. The test is for use by individuals 14 years or older taking and testing their own sample, or individuals 2 years and older with a sample taken and tested by an adult. The FDA reviewed 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. 

Validation data for the test was gathered through the Independent Test Assessment Program (ITAP), a National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx®) Tech program, in collaboration with the FDA. ITAP was launched in 2021 to accelerate test evaluation to support the FDA’s regulatory review and the availability of high-quality, accurate and reliable diagnostic tests to the public. 

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. Individuals who test positive for SARS-CoV-2 or flu should take appropriate precautions to avoid spreading the virus and should seek follow-up care with their physician or health care provider.

Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s less burdensome 510(k) pathway, whereby additional devices can obtain marketing clearance by demonstrating substantial equivalence to a predicate device.

Learn more: FDA Authorizes Marketing of First Home Flu and COVID-19 Combination Test Outside of Emergency Use Authorities | FDA

Get In Touch

We value your input and always appreciate feedback. Your suggestions and comments help us improve our services, ensuring that we consistently meet your needs and exceed your expectations.

Thank you we will get back to you shortly!

MO - FR 9:00 am - 5:00 pm

+ 420 774 557 550

info@baupharma.com

Czech Republic,
Nile House, Karolinská 654/2, Karlín, 186 00, Prague