SEKISUI Diagnostics Announces 510(k) Clearance and Launch of the OSOM® COVID-19/Flu A&B Combo Test

Original from: PR Newswire

SEKISUI Diagnostics, a global medical diagnostics manufacturer, has announced the launch of a 510(k) cleared rapid test to detect COVID-19 and Flu A&B in professional healthcare settings.

The OSOM® COVID-19/Flu A&B Combo Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of respiratory tract infection. CLIA-waived for point-of-care use, the OSOM COVID-19/Flu A&B Combo Test is manufactured in the USA and backed by an experienced technical services team of medical laboratory professionals.

The OSOM COVID-19/Flu A&B Combo Test includes QC Inside®, a unique feature which maximizes the value of every kit by eliminating separate Quality Control (QC) costs and provides two additional patient tests for external QC at no charge. 

"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.

As COVID-19 and influenza continue to present with overlapping symptoms, multiplex testing provides the advantage of identifying and differentiating multiple respiratory viruses from a single patient sample, helping support timely clinical decisions.

SEKISUI Diagnostics is a well-known provider of many rapid diagnostic solutions to the professional and home testing markets through a portfolio of tests under the OSOM and Metrix® brands.

Source: SEKISUI Diagnostics Announces 510(k) Clearance and Launch of the OSOM® COVID-19/Flu A&B Combo Test