Sekisui’s New OSOM Ultra Plus Flu A&B Test to Help Diagnose Respiratory Infections Amid COVID-19 Pandemic

Sekisui Diagnostics (Burlington, MA, USA) has received US Food and Drug Administration (FDA) 510(k) clearance and CLIA Waiver for its OSOM Ultra Plus Flu A&B Test.

The test is expected to help healthcare professionals accurately diagnose influenza, which is important given the shortage of SARS-CoV-2 tests due to the COVID-19 pandemic. The OSOM Ultra Plus Flu A&B Test 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. It utilizes traditional lateral flow technology with performance near or exceeding sensitivity of other reader-based tests without using an instrument.


"The clearance of the OSOM Ultra Plus Flu A&B Test heightens the performance of our flu portfolio allowing us to provide a more accurate rapid influenza test kit to many different institutions including nursing homes, chronic care facilities, and hospitals which the CDC acknowledges is useful for public health purposes to detect influenza outbreaks," 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 not widely available. We are proud to be able to provide another diagnostic tool which can help protect patients and our communities."