The CLIA-waived test detects and differentiates SARS-CoV-2, influenza A, and influenza B from a single nasal swab for point-of-care use.
Sekisui Diagnostics has launched its 510(k)-cleared rapid test to detect and differentiate COVID-19, influenza A, and influenza B in professional healthcare environments.
The OSOM COVID-19/Flu A&B Combo Test is a lateral flow immunochromatographic assay designed for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens, as well as SARS-CoV-2 nucleocapsid antigen. The test utilizes anterior nasal swab specimens collected directly from individuals exhibiting signs and symptoms of respiratory tract infection.
The assay is CLIA-waived for point-of-care use, manufactured in the US, and supported by a technical services team composed of medical laboratory professionals.
Because COVID-19 and influenza often present with overlapping clinical symptoms, multiplex point-of-care testing enables healthcare providers to evaluate multiple respiratory viruses from a single patient sample to guide clinical decision-making during respiratory season.
“With the Emergency Use Authorization ending, we know it is extremely important to continue to supply the market with the tools needed to diagnose respiratory infections quickly and accurately. We are pleased to be able to offer new customers and transition existing customers to a 510(k) cleared alternative as we enter the season, so they are well prepared before the termination takes effect,” says Erica Blight, vice president of strategy and growth, in a release.
Quality Control Integration
The test kit incorporates QC Inside, a design feature that includes two additional patient tests designated for external quality control testing at no additional charge, eliminating the need to purchase separate quality control kits.
The combo assay expands the company’s existing portfolio of rapid diagnostic products for professional and point-of-care settings, which includes lateral flow and diagnostic products under the OSOM and Metrix brands.
Photo caption: OSOM COVID-19/Flu A&B Combo Test
Photo credit: Sekisui Diagnostics
