November 17, 2020 – SEKISUI Diagnostics announced it received CE Marking for the OSOM Ultra Plus Flu A&B Test and has begun marketing the product in Europe.
The test uses traditional lateral flow technology with performance near or exceeding sensitivity of other reader-based tests without using an instrument, the company says.
It is intended for the qualitative detection of influenza type A and type B nucleoprotein antigens directly from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection.
“The CE Marking of the OSOM Ultra Plus Flu A&B Test expands our flu portfolio allowing us to provide a more accurate rapid influenza test kit to many different institutions in more countries. The WHO acknowledges that rapid influenza testing can have important case management implications, specifically allowing the use of influenza antivirals. Other benefits may include the isolation, clustering and analysis of confirmed cases to help prevent outbreaks in the hospital setting and the reduction of the inappropriate use of antibiotics.” said Robert Schruender, president and CEO of SEKISUI Diagnostics.
“Accurate diagnosis of influenza is critical to rule in or rule out the flu and can help guide healthcare professionals when trying to diagnose other respiratory infections. This is especially important in our current situation where SARS-CoV-2 Tests are still not widely available. We are proud to be able to provide another diagnostic tool which can help protect patients and our communities.”