Sekisui Diagnostics OSOM™ Ultra Flu A and B Rapid Test

Includes

25 Tests

OSOM Ultra Flu A&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 5mL 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.

For Use With (Application)

For the detection of Influenza type A and type B nucleoprotein antigens

Certifications/Compliance

Cleared for use with multiple viral transport media (VTM) types

Specificity

Influenza A = 99.4%; Influenza B =  99% vs PCR

Test Time

10 to 15 min.

Quantity

25 Tests/Pk.

Content And Storage

Room Temperature

CPT Code

Flu A: 87804; Flu B: 87804-59 (modifier used to indicate separate test)

Description

OSOM Ultra Flu A and B Rapid Test

Detectable Analytes

Influenza Type A and Type B

Includes

25 Tests/Pk.

Sample Type

Nasal and Nasopharyngeal Swab; also accepts Nasal Aspirate/Wash, but sold separately

Type

OSOM Ultra Flu A and B Rapid Test

Sensitivity

Influenza A: 89.2%, Influenza B: 86.4% vs. PCR

Clia Complexity

Waived/Moderate (depending on sample type)