COVID-19 and Flu Combo Test Launches With FDA Clearance

Rapid differentiation from a single specimen can streamline triage and support timely treatment decisions, making multiplex antigen testing useful for identifying multiple respiratory viruses in one workflow. A new combo test applies this approach to detect and differentiate SARS-CoV-2 and influenza A/B at the point of care using a single anterior nasal swab.

Sekisui Diagnostics (Burlington, MA, USA) has launched the 510(k)-cleared OSOM COVID-19/Flu A&B Combo Test for professional healthcare settings. Manufactured in the United States, the assay is CLIA-waived for point-of-care use. Its introduction expands the company’s OSOM portfolio of rapid diagnostic solutions for clinical environments where timely results are needed to support patient care.

The combo test uses a lateral flow immunochromatographic assay for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen. It analyzes anterior nasal swab specimens collected directly from individuals with signs and symptoms of respiratory tract infection. By combining these targets in a single cartridge, the assay enables simultaneous detection of three pathogens while retaining a simple specimen collection process and familiar point-of-care workflows.

The test’s 510(k) clearance and CLIA-waived status support its operation in point-of-care settings. To support quality control within these workflows, it incorporates QC Inside, a feature designed to eliminate separate quality control costs and provide two additional patient tests for external quality control at no charge. With COVID-19 and influenza continuing to cause overlapping symptoms, the company notes that this multiplex approach can help clinicians identify and differentiate multiple respiratory viruses from a single patient sample, supporting timely clinical decisions.

“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,” said Erica Blight, VP Strategy & Growth.