Sekisui Diagnostics announced it received FDA clearance and CLIA Waiver of the OSOM Ultra Plus Flu A&B Test 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.
According tot he company, the test utilizes traditional lateral flow technology with performance near or exceeding sensitivity of other reader-based tests without using an instrument.
Sekisui Diagnostics offers all three commonly used modalities in the CLIA Waived environment via four different tests:
- OSOM® Ultra Plus Flu A&B Test (lateral flow dipstick)
- OSOM® Ultra Flu A&B Test (lateral flow cartridge)
- Acucy Influenza A&B Test (point-of-care reader)
- Silaris® Influenza A&B Test (molecular point-of-care)
Sekisui Diagnostics offers more options to address the varying needs of customers to help improve patient outcomes, maximize clinical efficiencies, and reduce operational budgets.
“Reflecting on the unprecedented respiratory season this year, we have seen the value of tests that can respond to high volume clinical demand no matter where testing occurs,” said David Morris, PhD, Sr. Product Manager. “Rapid, point-of-care testing continues to be an essential tool in the healthcare system’s ability to respond to surges in testing demand and to reduce the spread of respiratory infections.”