San Diego – October 29, 2026 -- SEKISUI Diagnostics has launched the OSOM COVID-19/Flu A&B Combo Test, a 510(k)-cleared rapid test that detects and differentiates SARS-CoV-2 and influenza A and B from a single anterior nasal swab in professional healthcare settings.
CLIA-waived assay is manufactured in the USA for point-of-care use
The product is a lateral flow immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen. It is intended for individuals with signs and symptoms of respiratory tract infection. SEKISUI Diagnostics manufactures the test in the USA and backs it with a technical services team of medical laboratory professionals.
QC Inside feature removes separate quality control costs
Each kit includes QC Inside, which eliminates separate quality control (QC) costs. It also provides two additional patient tests for external QC at no charge.
Launch targets customers ahead of Emergency Use Authorization termination
Erica Blight, VP Strategy & Growth, said that with the Emergency Use Authorization ending, it is "extremely important" to keep supplying tools for fast, accurate diagnosis of respiratory infections. SEKISUI Diagnostics is offering the cleared test to new customers and transitioning existing customers to it as the respiratory season begins, so they are prepared before the termination takes effect.
COVID-19 and influenza continue to present with overlapping symptoms. Multiplex testing identifies and differentiates several respiratory viruses from one patient sample, which supports timely clinical decisions.