SEKISUI Diagnostics™ OSOM™ Ultra Flu A and B Rapid Test

Description

OSOM™ Ultra Flu A and B is a rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab and nasal aspirate/wash specimens.

Improved Outcomes: Rapid and accurate diagnosis of Influenza enables a choice of antiviral therapy, helps avoid the overuse of antibiotics, and prevents healthcare costs related to unnecessary testing and treatment.

Patient Experience: Streamlines lab's workflow while reducing patient wait time and unnecessary use of antibiotics.

• For the detection of Influenza type A and type B nucleoprotein antigens
• Able to meet FDA reclassification standards
• Multiple specimen types: nasal swab, nasopharyngeal swab and nasal aspirate/wash specimens
• Cleared for use with multiple viral transport media (VTM) types
• Accuracy: Influenza A Sensitivity: >90%; Influenza B: >85% vs culture (across multiple sample types)
• Fast: Obtain positive results in 10 to 15 minutes
• Flexible: Runs from nasal swab, NP swab as well as nasal aspirate/wash
• Workflow: approved for use with multiple viral transport media types
• QC Inside: 2 extra no charge cassettes to the kit

OSOM Ultra Flu A and B Control Kit (Cat. No. 22321114): 5 x positive Flu A/B swabs and 5 x Negative Flu A/B swabs
OSOM Ultra Flu A and B Nasopharyngeal Wash/Aspirate Kit (Cat. No. 22321106): 50 pipets and 5 mL extraction reagent
OSOM Ultra Flu A and B Swab Transport Kit (Cat. No. 22321107): 25 swabs in transport tubes

Storage Requirements:Store at room temperature.

Compliance

Meets FDA Reclassification

Recommended Storage

Store at room temperature.

Specifications

• Certifications/Compliance: Cleared for use with multiple viral transport media (VTM) types
• Content And Storage: Room Temperature
• CPT Code: Flu A: 87804; Flu B: 87804-59 (modifier used to indicate separate test)
• Clia Complexity: Waived, Moderate
• Detectable Analytes: Influenza A and B
• Format: Kit
• Sample Type: Nasal and Nasopharyngeal Swab, Nasal Aspirate/Wash
• Sensitivity: Influenza A: 89.2%, Influenza B: 86.4% vs. PCR
• Type: OSOM Ultra Flu A and B Rapid Test
• Includes: 25 Test Kits
• Specificity: Influenza A: 99.4%, Influenza B: 99% vs PCR
• Test Time: 10 to 15 min.