SEKISUI Diagnostics™ OSOM™ Ultra Plus Flu A and B Test Kit

Description

Use OSOM™ Ultra Plus Flu A and B Test Kit to detect influenza type A and B in just 10 minutes with minimal hands-on time, simplified workflow, and two additional tests for quality testing at no additional charge.

The OSOM™ Ultra Plus Flu A and B Test is an in vitro rapid qualitative test that detects influenza type A and B nucleoprotein antigens directly from nasal and nasopharyngeal swab specimens obtained from patients. High sensitivity and specificity allow for accurate diagnostic testing that is both efficient and cost-effective, allowing for diagnosis and treatment during the same visit.

• Fast diagnosis - read test results in just 10 minutes
• Trust your results - high sensitivity and specificity for more accurate diagnosis
• Save time - pre-filled extraction buffer vial to reduce hands-on time
• Ready-to-use - everything needed to run test is included, with no need for specialized instruments
• QC Inside™ - two extra tests included at no additional charge to run external quality control testing for more confidence in your results

Specifications

• Certifications/Compliance: CLIA waived, 510k approved
• Content And Storage: Room Temperature (15°C to 30°C, 59°F to 86°F)
• Control Sets: Included
• CPT Code: 87804QW (Flu A), 87804QW-59 (Flu B)
• Clia Complexity: Waived (Nasal and NP Swab)
• Detectable Analytes: Influenza A and B
• Detection Method: Influenza antigens from nasal or NP swabs
• DoA Calibrators: No
• Format: Manual Dipstick
• Sensitivity: A: 90.3% B: 88.0%
• Type: Rapid Test
• Includes: 25 test sticks, 25 nasal swabs, 25 extraction buffer vials, Influenza A+ Control Swab, Influenza B+ Control Swab, IFU, QRG, Workstation
• Packaging Type: Test Kit
• 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
• Specificity: A: 96.7% B: 99.2%
• Test Time: 10 min.
• Analysis Time: 10 min.