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

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

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.