Quidel secures FDA emergency use authorisation for Covid-19 antigen test

11 May 2020 (Last Updated May 11th, 2020 14:20)

Quidel has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) to market its Sofia 2 SARS Antigen FIA, a rapid, point-of-care test for the Covid-19 diagnosis.

Quidel secures FDA emergency use authorisation for Covid-19 antigen test
Quidel’s Sofia 2 SARS Antigen FIA test uses Sofia 2 Fluorescent Immunoassay Analyser for the rapid detection of SARS-CoV-2 virus. Credit: Governor Tom Wolf.

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Quidel has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) to market its Sofia 2 SARS Antigen FIA, a rapid, point-of-care test for the Covid-19 diagnosis.

The test will be used with Sofia 2 Fluorescent Immunoassay Analyser for the rapid detection of SARS-CoV-2 virus in nasal or nasopharyngeal specimens from patients with Covid-19 symptoms.

Sofia 2 is the company’s latest version of its Sofia instrumented system. It uses the original Sofia fluorescent chemistry design.

It has improved graphical user interface and optics system to deliver accurate, objective and automated result in 15 minutes.

The system is connected to Quidel’s data management system Virena, which provides aggregated, de-identified testing data in near real time.

Furthermore, Sofia 2 instrument can offer two distinct workflows, depending on the user’s choice.

For automatically timed development or WaLK AWAY Mode, the Sofia 2 SARS Antigen FIA cartridge is placed inside Sofia 2.

The READ NOW Mode allows test cartridges to be placed on the counter or benchtop for a manually timed development and then placed into Sofia 2 to be scanned. This enables the user to considerably increase testing throughput per hour.

Quidel CEO and president Douglas Bryant said: “In the fight against Covid-19, our employees are truly making a difference, and I am tremendously proud of our organisation’s ability to quickly develop and mobilise an accurate rapid antigen test.

“The EUA for our Sofia 2 SARS Antigen FIA allows us to arm our healthcare workers and first responders with a frontline solution for Covid-19 diagnosis, accelerating the time to diagnosis and potential treatment of Covid-19 for the patient.”

Sofia 2 SARS Antigen FIA test is currently available for sale in the US under EUA.  Healthcare professionals can purchase the assay through distribution representatives for Cardinal Health, Fisher Healthcare, Henry Schein or McKesson.

The company is currently shipping the product to its customers.