The test is intended for individuals aged 14 years or older for self-collection, or for samples collected from younger individuals (aged 2 years or older) by adults, and should be used within the first 5 days of symptom onset.

Dr. Michelle Tarver from the FDA emphasized the test's significance as the flu season approaches, enhancing home-testing options for respiratory illnesses.

The FDA has authorized Healgen Scientific's Rapid Check COVID-19/Flu A&B Antigen Test for home use without a prescription, marking a significant milestone for the company.

This test is specifically designed for individuals experiencing respiratory symptoms and is notable for being marketed through the traditional approval pathway rather than under emergency use.

The authorization aims to enhance the ability to detect respiratory illnesses effectively at home as flu season approaches.

Healgen's CEO, Bingliang Fang, highlighted that the test provides a reliable and user-friendly option for at-home diagnostics, facilitating early diagnosis and treatment.

Clinical studies indicated the test correctly identified 99% of negative SARS-CoV-2 samples and 92% of positive samples, along with high accuracy for Flu A and B.

The Healgen home tests are expected to be available over the counter by Thanksgiving 2023, priced between $13 and $16 each, sold through retailers such as CVS and Amazon.

Healgen plans to increase production of the respiratory tests to meet the anticipated demand for the upcoming fall respiratory season, according to company president Bryan Fang.

The FDA recommends taking the test if experiencing respiratory symptoms, but individuals showing symptoms should seek healthcare advice regardless of test results.

The authorization was announced on a Monday, coinciding with the availability of four free COVID-19 tests per household from the U.S. Department of Health and Human Services.

The FDA warns of potential false negative results, advising individuals with ongoing symptoms to consult their healthcare provider, even if test results are negative.