The US Food and Drug Administration (FDA) has granted Emergency Use Authorisation (EUA) to Quidel ’s QuickVue SARS Antigen test for Covid-19 testing.
The point-of-care assay is approved for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 using anterior nares (NS) swab samples taken by healthcare provider from people suspected of Covid-19 within five days of symptom onset.
It needs no supplemental instrumentation and can be read visually.
The QuickVue SARS Antigen test delivers results in just ten minutes and has shown excellent performance for detecting the Covid-19 virus with 96.6% PPA and 99.3% NPA when compared with PCR.
Quidel Corporation 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 democratise 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.”
Quidel anticipates reaching a production run rate of 600 million QuickVue tests a year by the end of next year.
In May, the company received FDA EUA for the Lyra Direct SARS-CoV-2 Assay to allow direct Covid-19 test sample processing.
In September 1999, Quidel’s QuickVue Influenza A/B Test, the first visually read lateral flow flu test, received FDA approval.
Another Quidel cartridge-based, instrument-read rapid diagnostic system for infectious disease testing, Sofia 2 makes use of fluorescent chemistry design, an intuitive graphical user interface and optics system to deliver results in 15 minutes.