Fisher Healthcare™ Sure-Vue™ Signature Influenza A and B Test Kit

Description

Sure-Vue™ Signature Influenza A and B Test Kit for 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 efficient and cost-effective.

• 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%
• 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

Specifications

• Certifications/Compliance: CLIA waived, 510k approved
• Content And Storage: Room Temperature (15°C to 30°C, 59°F to 86°F)
• 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
• For Use With (Application): Lateral Flow 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
• Product Line: Sure-Vue™ Signature
• Quantity: 25 Tests
• Specificity: A: 96.7%, B: 99.2%
• Test Time: 10 min.
• Analysis Time: 10 min.