Healgen has received the US Food and Drug Administration’s (FDA) marketing authorisation for its Rapid Check Covid-19/Flu A&B Antigen Test.
It is said to be the first OTC test that can detect both Covid-19 and influenza using a traditional premarket review pathway, rather than an emergency use declaration.
The Healgen Rapid Check test is designed for individuals aged 14 and above to self-administer, and for adults to administer to children as young as two years old.
It uses a nasal swab to detect proteins from the SARS-CoV-2 virus that causes Covid-19, and influenza A and B, delivering results within approximately 15 minutes.
Clinical study data demonstrated that the test accurately identified 99% of negative and 92% of positive SARS-CoV-2 samples, as well as 99.9% of negative flu samples.
For positive flu samples, the accuracy was 92.5% for influenza A and 90.5% for influenza B.
The FDA's decision was supported by validation data from the Independent Test Assessment Programme, a collaborative effort between the National Institutes of Health Rapid Acceleration of Diagnostics Tech programme and the FDA.
FDA Centre for Devices and Radiological Health acting director Dr Michelle Tarver said: “As we enter this year’s annual flu season with respiratory illnesses such as Covid-19 on many of our minds, our ability to detect these pathogens effectively and efficiently can be impactful on our daily lives.
“Today’s authorisation expands the options for individuals with respiratory symptoms to receive information about their health from the comfort of their home.”
Despite the convenience of rapid antigen tests, the FDA cautions that they generally have lower sensitivity compared with molecular tests, which could result in false negatives.
Individuals who receive negative results but continue to exhibit symptoms should seek further medical advice. Those who test positive are advised to take appropriate measures to prevent virus transmission and consult with a healthcare provider.
