22-321-114
SEKISUI Diagnostics™ OSOM™ Ultra Flu A and B Test Control Swab Kit
Manufacturer: SEKISUI Diagnostics™
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Certifications/Compliance
Cleared for use with multiple viral transport media (VTM) types
CPT Code
Flu A: 87804; Flu B: 87804-59 (modifier used to indicate separate test)
Sample Type
Nasal Aspirate/Wash, Nasal Swab, Nasopharyngeal Swab
Type
OSOM Ultra Flu A and B Test Control Swab Kit
Test Time
10 to 15 min.
Content And Storage
Room Temperature
Detectable Analytes
Influenza A and B
Sensitivity
Influenza A: >90%, Influenza B: >80% vs Culture
Includes
5 x positive Flu A/B swabs and 5 x Negative Flu A/B swabs
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Description
- Improved Outcomes: Rapid and accurate diagnosis of Influenza enables a choice of antiviral therapy, helps avoid the overuse of antibiotics, and prevents healthcare costs related to unnecessary testing and treatment
- Patient Experience: Streamlines lab's workflow while reducing patient wait time and unnecessary use of antibiotics
- For the detection of Influenza type A and type B nucleoprotein antigens Able to meet FDA reclassification standards Multiple specimen types: nasal swab, nasopharyngeal swab and nasal aspirate/wash specimens Cleared for use with multiple viral transport media (VTM) types Accuracy: Influenza A Sensitivity: >90%; Influenza B: >85% vs culture (across multiple sample types) Fast: Obtain positive results in 10 to 15 minutes Flexible: Runs from nasal swab, NP swab as well as nasal aspirate/wash Workflow: approved for use with multiple viral transport media types QC Inside: 2 extra no charge cassettes to the kit OSOM Ultra Flu A and B Control Kit (Cat
- No
- 22321114): 5 x positive Flu A/B swabs and 5 x Negative Flu A/B swabs OSOM Ultra Flu A and B Nasopharyngeal Wash/Aspirate Kit (Cat
- No
- 22321106): 50 pipets and 5 mL extraction reagent OSOM Ultra Flu A and B Swab Transport Kit (Cat
- No
- 22321107): 25 swabs in transport tubes Recommended Storage Store at room temperature.
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Certifications/Compliance: Cleared for use with multiple viral transport media (VTM) types
CPT Code: Flu A: 87804; Flu B: 87804-59 (modifier used to indicate separate test)
Sample Type: Nasal Aspirate/Wash, Nasal Swab, Nasopharyngeal Swab
Type: OSOM Ultra Flu A and B Test Control Swab Kit
Test Time: 10 to 15 min.
Content And Storage: Room Temperature
Detectable Analytes: Influenza A and B
Sensitivity: Influenza A: >90%, Influenza B: >80% vs Culture
Includes: 5 x positive Flu A/B swabs and 5 x Negative Flu A/B swabs
Certifications/Compliance:
Cleared for use with multiple viral transport media (VTM) types
CPT Code:
Flu A: 87804; Flu B: 87804-59 (modifier used to indicate separate test)
Sample Type:
Nasal Aspirate/Wash, Nasal Swab, Nasopharyngeal Swab
Type:
OSOM Ultra Flu A and B Test Control Swab Kit
Test Time:
10 to 15 min.
Content And Storage:
Room Temperature
Detectable Analytes:
Influenza A and B
Sensitivity:
Influenza A: >90%, Influenza B: >80% vs Culture
Includes:
5 x positive Flu A/B swabs and 5 x Negative Flu A/B swabs
Certifications/Compliance: __
CPT Code: __
Sample Type: __
Type: Accuracy Reader
Test Time: __
Content And Storage: __
Detectable Analytes: __
Sensitivity: __
Includes: Acucy Reader, Acucy Printer, Acucy Calibration Device, USB Memory Drive, Power Cords, Power Converters, Password Card, System Manual
Certifications/Compliance:
__
CPT Code:
__
Sample Type:
__
Type:
Accuracy Reader
Test Time:
__
Content And Storage:
__
Detectable Analytes:
__
Sensitivity:
__
Includes:
Acucy Reader, Acucy Printer, Acucy Calibration Device, USB Memory Drive, Power Cords, Power Converters, Password Card, System Manual
Certifications/Compliance: __
CPT Code: 87804QW
Sample Type: Nasal and Nasopharyngeal Swabs
Type: Flu test
Test Time: __
Content And Storage: Room Temperature (15°C to 30°C, 59°F to 86°F)
Detectable Analytes: Influenza A and B
Sensitivity: Influenza A: 96.4% (95% CI: 93.1% to 98.2%), Influenza B: 82.3% (95% CI: 75.6% to 87.4%)
Includes: 25 Test Cassettes, 25 Sterile Nasal Swabs, 25 Extraction Buffer vials each containing 0.4 mL phosphate buffered salt solution (with 0.09% sodium azide as a preservative), 25 Extraction Vial Dropper Tips, 1 Influenza A+/B- Control Swab, 1 Influenza A-/B+ Control Swab, 1 Instructions for Use (IFU), 1 Quick Reference Guide, 1 Workstation, and 1 External Quality Control (QC) Quick Reference Guide
Certifications/Compliance:
__
CPT Code:
87804QW
Sample Type:
Nasal and Nasopharyngeal Swabs
Type:
Flu test
Test Time:
__
Content And Storage:
Room Temperature (15°C to 30°C, 59°F to 86°F)
Detectable Analytes:
Influenza A and B
Sensitivity:
Influenza A: 96.4% (95% CI: 93.1% to 98.2%), Influenza B: 82.3% (95% CI: 75.6% to 87.4%)
Includes:
25 Test Cassettes, 25 Sterile Nasal Swabs, 25 Extraction Buffer vials each containing 0.4 mL phosphate buffered salt solution (with 0.09% sodium azide as a preservative), 25 Extraction Vial Dropper Tips, 1 Influenza A+/B- Control Swab, 1 Influenza A-/B+ Control Swab, 1 Instructions for Use (IFU), 1 Quick Reference Guide, 1 Workstation, and 1 External Quality Control (QC) Quick Reference Guide
Certifications/Compliance: __
CPT Code: 87804QW
Sample Type: Nasal, Nasopharyngeal
Type: Control Kit
Test Time: __
Content And Storage: Room Temperature (15°C to 30°C, 59°F to 86°F)
Detectable Analytes: Influenza A and B
Sensitivity: A: 96.4%, B: 82.3%
Includes: 5 Influenza A+/B- Control Swabs, 5 Influenza A-/B+ Control Swabs, Instructions For Use (IFU)
Certifications/Compliance:
__
CPT Code:
87804QW
Sample Type:
Nasal, Nasopharyngeal
Type:
Control Kit
Test Time:
__
Content And Storage:
Room Temperature (15°C to 30°C, 59°F to 86°F)
Detectable Analytes:
Influenza A and B
Sensitivity:
A: 96.4%, B: 82.3%
Includes:
5 Influenza A+/B- Control Swabs, 5 Influenza A-/B+ Control Swabs, Instructions For Use (IFU)