The OSOM Ultra Flu A & B Test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection.
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.
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
Along with influenza, Sekisui Diagnostics provides a broad line of OSOM® rapid tests for Strep A, Mononucleosis, Trichomonas, Bacterial Vaginosis, Helicobacter pylori, hCG and Fecal Occult Blood. Sekisui's expanding Point-of-Care product line also includes the FastPack® IP System, which offers a convenient, rapid, decentralized testing solution for Vitamin D, Testosterone, PSA, Free PSA, TSH, Free T4, and hCG.