22-321-105
SEKISUI Diagnostics™ OSOM™ Ultra Flu A and B Rapid Test
Manufacturer: Fischer Scientific
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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)
Detectable Analytes
Influenza A and B
Sample Type
Nasal and Nasopharyngeal Swab, Nasal Aspirate/Wash
Type
OSOM Ultra Flu A and B Rapid Test
Specificity
Influenza A: 99.4%, Influenza B: 99% vs PCR
Content And Storage
Room Temperature
Clia Complexity
Waived, Moderate
Format
Kit
Sensitivity
Influenza A: 89.2%, Influenza B: 86.4% vs. PCR
Includes
25 Test Kits
Test Time
10 to 15 min.
Related Products
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 Storage Requirements: Store at room temperature
- Compliance Meets FDA Reclassification
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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)
Detectable Analytes: Influenza A and B
Sample Type: Nasal and Nasopharyngeal Swab, Nasal Aspirate/Wash
Type: OSOM Ultra Flu A and B Rapid Test
Specificity: Influenza A: 99.4%, Influenza B: 99% vs PCR
Content And Storage: Room Temperature
Clia Complexity: Waived, Moderate
Format: Kit
Sensitivity: Influenza A: 89.2%, Influenza B: 86.4% vs. PCR
Includes: 25 Test Kits
Test Time: 10 to 15 min.
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)
Detectable Analytes:
Influenza A and B
Sample Type:
Nasal and Nasopharyngeal Swab, Nasal Aspirate/Wash
Type:
OSOM Ultra Flu A and B Rapid Test
Specificity:
Influenza A: 99.4%, Influenza B: 99% vs PCR
Content And Storage:
Room Temperature
Clia Complexity:
Waived, Moderate
Format:
Kit
Sensitivity:
Influenza A: 89.2%, Influenza B: 86.4% vs. PCR
Includes:
25 Test Kits
Test Time:
10 to 15 min.
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)
Detectable Analytes: Influenza A and B
Sample Type: Nasal Aspirate/Wash, Nasal Swab, Nasopharyngeal Swab
Type: OSOM Ultra Flu A and B Nasopharyngeal Wash/Aspirate Kit
Specificity: __
Content And Storage: Room Temperature
Clia Complexity: __
Format: Kit
Sensitivity: Influenza A: >90%, Influenza B: >80% vs Culture
Includes: 50 Pipets and 5 mL Extraction Reagent
Test Time: 10 to 15 min.
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)
Detectable Analytes:
Influenza A and B
Sample Type:
Nasal Aspirate/Wash, Nasal Swab, Nasopharyngeal Swab
Type:
OSOM Ultra Flu A and B Nasopharyngeal Wash/Aspirate Kit
Specificity:
__
Content And Storage:
Room Temperature
Clia Complexity:
__
Format:
Kit
Sensitivity:
Influenza A: >90%, Influenza B: >80% vs Culture
Includes:
50 Pipets and 5 mL Extraction Reagent
Test Time:
10 to 15 min.
Certifications/Compliance: __
CPT Code: Diagnostic 82274QW; Screening G0328QW
Detectable Analytes: Hemoglobin
Sample Type: Stool
Type: Rapid Test Kits
Specificity: Human hemoglobin
Content And Storage: Store the kit or kit contents 2°C to 30°C (35.6°F to 86°F) until use. Do not freeze.
Clia Complexity: Waived
Format: Cassette
Sensitivity: 50 ng hHb/mL Buffer or 50 μg hHb/g Feces
Includes: 25 OSOM iFOB Test device in a sealed foil pouch, 25 Stool collection tube, with sampler, containing extraction buffer solution (PBS), 25 Collection paper, 25 Mailing Envelopes, Instructions for use, 25 Patient instructions for use, 25 Biohazard labeled bags with absorbent pads, Two extra test devices for external QC testing
Test Time: 5 to 10 min.
Certifications/Compliance:
__
CPT Code:
Diagnostic 82274QW; Screening G0328QW
Detectable Analytes:
Hemoglobin
Sample Type:
Stool
Type:
Rapid Test Kits
Specificity:
Human hemoglobin
Content And Storage:
Store the kit or kit contents 2°C to 30°C (35.6°F to 86°F) until use. Do not freeze.
Clia Complexity:
Waived
Format:
Cassette
Sensitivity:
50 ng hHb/mL Buffer or 50 μg hHb/g Feces
Includes:
25 OSOM iFOB Test device in a sealed foil pouch, 25 Stool collection tube, with sampler, containing extraction buffer solution (PBS), 25 Collection paper, 25 Mailing Envelopes, Instructions for use, 25 Patient instructions for use, 25 Biohazard labeled bags with absorbent pads, Two extra test devices for external QC testing
Test Time:
5 to 10 min.
Certifications/Compliance: __
CPT Code: __
Detectable Analytes: __
Sample Type: __
Type: Patient Sample Mailers
Specificity: __
Content And Storage: Store the kit or kit contents 2°C to 30°C until use. Do not freeze.
Clia Complexity: Not Applicable
Format: __
Sensitivity: __
Includes: 25 Patient Mailers
Test Time: 5 to 10 min.
Certifications/Compliance:
__
CPT Code:
__
Detectable Analytes:
__
Sample Type:
__
Type:
Patient Sample Mailers
Specificity:
__
Content And Storage:
Store the kit or kit contents 2°C to 30°C until use. Do not freeze.
Clia Complexity:
Not Applicable
Format:
__
Sensitivity:
__
Includes:
25 Patient Mailers
Test Time:
5 to 10 min.