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June 14, 2021

Quidel gets amended FDA EUA for Covid-19 antigen test device

Sofia Q uses Sofia fluorescent technology and offers precise, objective and automated results in 15 minutes. 

The US Food and Drug Administration (FDA) has expanded emergency use authorization (EUA) to market Quidel’s rapid Covid-19 antigen test device, Sofia Q.

The test device is an addition to the Sofia and Sofia 2 line of Fluorescent Immunoassay Analyzers (FIA), the company noted.

It has a miniaturised artificial intelligence (AI)-based design that reads the same Sofia SARS Antigen FIA tests as Sofia and Sofia 2 with similar accuracy.

Leveraging Sofia fluorescent technology, the new test delivers a precise, objective and automated result in 15 minutes.

The design allows the device to be used with the Sofia Q mobile application, which helps the customer through the workflow and reads the result of the test using an AI model.

Quidel president and CEO Douglas Bryant said: “Sofia Q is our latest powerful diagnostic instrument designed to democratise access to the many benefits of our Sofia SARS rapid antigen tests and, ultimately, our full portfolio of Sofia tests for influenza, RSV, Strep and other conditions.

“We designed Sofia Q to be very affordably priced and conducive to widespread adoption across the ever-expanding global point-of-care and telemedicine marketplace.”

The company intends to release the device for professional and point-of-care use and then expand to telemedicine and home markets.

In the initial stage, sales of Sofia Q will be limited to be used along with the Sofia SARS Antigen FIA in the CLIA and CLIA-certified professional sections.

Last month, Quidel partnered with drugstore chain Walgreens to make QuickVue at-home rapid antigen tests available without a prescription.

In another development, Avacta has received notice of registration of its AffiDX SARS-CoV-2 antigen lateral flow test in the European Union (EU).

The latest development permits Avacta to market the test for professional use in all 27 EU countries.

According to clinical data reported in April this year, the test had a sensitivity of 100% in detecting infectious individuals with viral loads measured by the polymerase chain reaction of cycle threshold (Ct) values of less than 27.

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