Quidel has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its QuickVue SARS rapid antigen test to diagnose Covid-19.

The point-of-care assay has been designed to facilitate the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares (NS) swab specimens directly from individuals who are suspected of Covid-19.

QuickVue SARS antigen test will enable the healthcare provider to identify suspected Covid-19 individuals within the first five days of the onset of symptoms.

Quidel’s new antigen test can be visually read and conducted without supplemental instrumentation.

According to the company, the point-of-care test provides improved performance for the detection of SARS-CoV-2 in anterior nares swab samples. The test provides results within 10 minutes.

Quidel stated that it intends to achieve a production run rate of 600 million QuickVue tests per year by the end of 2021.

Quidel president and CEO Douglas Bryant said: “The QuickVue rapid antigen test for coronavirus leverages our proven QuickVue visually read diagnostic platform for influenza A+B to further democratize access to affordable and highly accurate Covid-19 testing across a diverse range of medical and point-of-care locations.”

“The flexibility of QuickVue for meeting the urgent testing needs of everyone from school systems to rural areas and even locations without electricity gives us the opportunity to do enormous good in communities across our nation and the world.”

In October, Quidel secured EUA from the FDA for its Sofia 2 Flu + SARS Antigen FIA, which is also a rapid point-of-care diagnostic test.

Quidel is claimed to be the first company to secure EUA from the FDA for a rapid point-of-care antigen test for Covid-19.

The company also offers the QuickVue Influenza A/B test, which is said to be the first visually read lateral flow flu test that secured FDA approval in 1999.

In addition, QuickVue is claimed to be the first flu test to secure FDA approval for use in CLIA-waived point-of-care facilities such as doctors’ offices, urgent care clinics and pharmacies.