Trends in Anesthesiology

ASA Monitor 89(1):p 27, January 2025. 

FDA authorizes marketing of first home flu and COVID-19 combination test outside of emergency use authorities

The U.S. Food and Drug Administration (FDA) granted marketing authorization for the Healgen Rapid Check COVID-19/Flu A&B Antigen Test. The test, authorized for use without a prescription, is intended for individuals experiencing respiratory symptoms and uses a nasal swab sample to deliver at-home results in approximately 15 minutes for COVID-19 and influenza (flu). The test detects proteins from both SARS-CoV-2 and influenza A and B.

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 it 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 and 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 people 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.

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 physician. 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.

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.

Source: asamonitor.pub/3O4mvSI