The US Food and Drug Administration (FDA) has approved the Healgen Rapid Check Covid-19/Flu A&B Antigen Test for marketing.

To be available without a prescription, this lateral flow immunochromatographic test is said to be the first home flu and Covid-19 combination test outside of emergency use authorities.

The Healgen Rapid Check Covid-19/Flu A&B Antigen Test is intended for individuals aged 14 and older who can test their samples. It can also be used by those aged two and older with a sample collected and tested by an adult.

The product received the FDA’s Emergency Use Authorization (EUA) in June.

Designed for individuals with respiratory symptoms, the test uses an anterior nasal swab sample. The results are said to be ready in about 15 minutes.

The test detects proteins from both SARS-CoV-2, the virus responsible for Covid-19, and influenza A and B, the viruses that cause flu.

In addition, it is said to be the first over-the-counter (OTC) test to receive marketing authorisation through the traditional review process for influenza detection. This allows Healgen’s test for marketing in the absence of an applicable emergency use declaration.

Other OTC flu and Covid tests are only available under EUA.

FDA Center for Devices and Radiological Health acting director Michelle Tarver said: “Today’s authorisation expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home.

“The FDA continues to take actions that support the development and availability of at-home tests for a variety of medical conditions.”

The US regulator’s approval was based on data from a study that showed that this test accurately identified 99% of negative and 92% of positive SARS-CoV-2 samples.

It also detected 99.9% of negative Flu A and B samples, with 92.5% accuracy for positive Flu A and 90.5% for positive Flu B samples.

Validation data came from the Independent Test Assessment Program (ITAP), part of the National Institutes of Health’s (NIH) Rapid Acceleration of Diagnostics (RADx) Tech programme, in collaboration with the FDA.

The US health agency said there is a risk of false negatives as with all rapid antigen tests. These tests generally have lower sensitivity than molecular tests, as per the FDA.

According to Healgen, the Healgen Rapid Check Covid-19/Flu A&B Antigen Test should be conducted within the first five days of symptom onset for accurate results. It is recommended to test at least twice over three days, with a gap of 48 hours.