Sekisui Diagnostics™ OSOM Ultra Plus Flu A&B Test Kit

Delivers rapid detection of influenza type A and B nucleoprotein antigens directly from nasal and nasopharyngeal swab specimens from patients. High sensitivity and specificity allow for accurate diagnostic testing that is both efficient and cost-effective.

Manufacturer:  Sekisui Diagnostics™ 1032

Catalog No. 22-321-130

Description

• Results in 10 minutes
• High performance - near or exceeding that of traditionally more sensitive reader devices without the need for an instrument
• Sensitivity for flu A: 90.3%; flu B: 88%
• Specificity for flu A: 96.7%; flu B: 99.2%

Specifications

• Clia Complexity: CLIA waived for nasal swab and NP swab
• Sensitivity: A: 90.3% B: 96.7%
• Test Time: 10 minutes
• Shelf Life: 18 months from manufacture maximum
• Technology: Lateral Flow
• Final Product Type: OSOM Ultra Plus Flu A&B Test Kit
• Certifications/Compliance: CLIA waived, 510k approved
• CE Marker: No
• Includes: 25 test sticks, 25 nasal swabs, 25 extraction buffer vials, Influenza A+ Control Swab, Influenza B+ Control Swab, IFU, QRG, Workstation
• Product Type: Influenza A&B immunoassay

• Kit Size: 25 Tests/kit
• Specificity: A: 88.0% B: 99.2%
• Storage Requirements: 15°C to 30°C
• Target Organism Class: N/A - Virus
• Detection Method: Influenza antigens from nasal or NP swabs
• Species: Performance characteristics for influenza A were established during the U.S. 2018-2019 influenza season when A/H1N1pdm09 and influenza A/H3N2 were the predominant influenza A viruses in circulation, and the influenza B Yamagata and Victoria lineages were in co-circulation
• Format: Manual dipstick
• Detectable Analytes: Influenza A & Influenza B
• Packaging: Kit