Sekisui Diagnostics Launches 510(k)-Cleared COVID-19/Flu Combo Test
Sekisui Diagnostics has launched a 510(k)-cleared rapid diagnostic test to detect and differentiate COVID-19, influenza A, and influenza B in professional healthcare environments, replacing temporary emergency authorizations as respiratory virus season begins.
Key Clinical Takeaways:
- The OSOM COVID-19/Flu A&B Combo Test detects SARS-CoV-2, influenza A, and influenza B nucleoprotein antigens from a single anterior nasal swab.
- The assay holds a CLIA waiver for point-of-care clinical use and is manufactured in the United States.
- Each kit includes two additional patient tests designated for external quality control testing at no additional charge.
OSOM COVID-19/Flu A&B Combo Test Design
The OSOM COVID-19/Flu A&B Combo Test functions as a lateral flow immunochromatographic assay. It is engineered for the qualitative detection and differentiation of influenza A nucleoprotein antigens, influenza B nucleoprotein antigens, and SARS-CoV-2 nucleocapsid antigens. Healthcare providers administer the test using anterior nasal swab specimens collected directly from individuals who exhibit signs and symptoms of a respiratory tract infection.
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.
Sekisui Diagnostics Launches 510(K) Cleared Respiratory Test
The commercial launch follows the expiration of previous regulatory flexibilities for diagnostic products. Erica Blight, vice president of strategy and growth at Sekisui Diagnostics, addressed the timing of the market entry in a public release.
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.
QC Inside Feature Removes Need for Separate Kits
The test kit incorporates a design feature designated as QC Inside. This inclusion provides two additional patient tests allocated specifically for external quality control testing at no additional cost. The feature eliminates the requirement for laboratories and clinics to purchase separate quality control kits.
Manufacturing of the combo assay takes place in the United States. Technical support for the product is provided by a team composed of medical laboratory professionals. The new assay broadens the company’s existing portfolio of rapid diagnostic products for professional and point-of-care settings, which already includes lateral flow and diagnostic products distributed under the OSOM and Metrix brands.
Disclaimer: The information provided in this article is for educational and scientific communication purposes only and does not constitute medical advice. Always consult with a qualified healthcare provider regarding any medical condition, diagnosis, or treatment plan.