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

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

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

Specificity

A: 96.7%, B: 99.2%

Test Time

10 min.

Analysis Time

10 min.