Quidel has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its rapid antigen Covid-19 diagnostic assay.
The FDA EUA status allows the company’s its Sofia 2 SARS Antigen FIA rapid point-of-care test to be used with the Sofia 2 fluorescent immunoassay analyser to rapidly detect SARS-CoV-2 in nasal or nasopharyngeal specimens from patients meeting the Centers for Disease Control and Prevention’s (CDC) criteria for suspected COVID-19 infection.
Sofia 2, which is the firm’s next-generation version of Sofia instrumented system, applies the original Sofia fluorescent chemistry design while enhancing the graphical user interface and optics system to offer a precise, objective and automated result in 15 minutes.
The next-generation Sofia 2 system can also be connected to Quidel’s data management system, which offers aggregated and de-identified testing data in near real-time.
Quidel’s Sofia 2 instrument provides two specific workflows based on the user’s choice
Quidel’s Sofia 2 instrument also delivers two specific workflows based on the user’s choice. The Sofia 2 SARS Antigen FIA cartridge is fixed inside Sofia 2 for automatically timed development, and the test cartridges can also be placed on the counter or benchtop for a manually timed development and then placed into Sofia 2 for scanning.
Quidel president and CEO Douglas Bryant said: “In the fight against Covid-19, our employees are truly making a difference, and I am tremendously proud of our organization’s ability to quickly develop and mobilize 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.”
In March, Quidel secured FDA EUA status for Lyra SARS-CoV-2 assay, a real-time RT-PCR test designed to help healthcare providers in the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients suspected of COVID-19.
Quidel also provides other FDA cleared and CLIA waived assays, including tests for Influenza A and B, Respiratory Syncytial Virus (RSV), Group A Strep, and a 12-minute finger-stick whole blood test for Lyme Disease.
