LEXINGTON, Mass., Nov. 10, 2016 /PRNewswire/ -- Today, Sekisui Diagnostics announces the U.S. Food and Drug Administration (FDA) has granted Clinical Laboratory Improvement Amendments (CLIA) Waiver status for the OSOM® Ultra Flu A&B Test using swab samples.
The OSOM® Ultra Flu A&B Test delivers fast, accurate results in 10-15 minutes by utilizing a simple procedure across multiple sample types, including nasal swabs, nasopharyngeal swabs, and in moderate settings, nasopharyngeal aspirate/wash. The performance of the OSOM® kit by users at CLIA waived sites was measured against the preferred standard of polymerase chain reaction (PCR), with a Positive Percent Agreement of 89.2% for Flu A and 86.4% for Flu B and Negative Percent Agreement of 99.4% for Flu A and 99.0% for Flu B. According to the CDC Foundation, there are approximately 31.4 million outpatient visits and 200,000 hospitalizations each year related to influenza. 1 An estimated 20 million rapid tests have been performed in the U.S. each year since 2013, with a projected 4.5% CAGR through 2019. 2,3 CLIA waiver designation will enable healthcare providers to perform the OSOM® Ultra Flu A&B Test using nasal or nasopharyngeal swabs, to deliver simple and accurate test results in locations such as the emergency room, community-based settings, urgent care and physician offices. By using the OSOM® Ultra Flu A&B Test healthcare practitioners will provide patients with a rapid, accurate diagnosis while on site, thereby helping prevent unnecessary antibiotic prescriptions, reduce hospitalization, and minimize influenza transmission. 4