- Condition: Factory New
- Warranty: Not Available
- Weight: 1.47 lb
- Rapid diagnosis for early treatment
- Innovative flip test design
- Easy to read cassette
- Positive results are ready in 10 minutes
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Learn more:
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Purchasing Restriction: Medical license or prescription required
- MFR: LifeSign Ships from Manufacturer
- MPN: 36025
- Phone: (800) 526-2125
Frequently asked questions
How quickly does the LifeSign Status Flu A&B Test provide results?
The LifeSign Status Flu A&B Test delivers positive results in just 10 minutes, facilitating quicker decisions regarding treatment. This rapid turnaround time is crucial in managing and controlling the spread of influenza.
Does this test detect both influenza A and B?
Yes, the LifeSign Status Flu A&B Test is designed to detect both influenza A and influenza B antigens, offering comprehensive detection in a single test. It also detects H1N1 (Swine Flu).
Which specimen types are compatible with this rapid test?
The LifeSign Status Flu A&B Test is compatible with the following specimen types for detecting Influenza A and B antigens:
- Nasal swab
- Nasopharyngeal swab
- Nasal aspirate/wash specimens
The kit is designed for enhanced specimen collection and patient comfort, including specialized flocked nasal swabs.
What is the accuracy of the Status Flu A&B Test?
The LifeSign Status Flu A&B Test provides excellent diagnostic accuracy and meets the new FDA reclassification performance criteria. Performance metrics include:
Influenza A
- Positive Percent Agreement (PPA): 89.2% (95% CI: 83.0-93.4%)
- Negative Percent Agreement (NPA): 99.4% (95% CI: 97.7-99.8%)
Influenza B
- Positive Percent Agreement (PPA): 86.4% (95% CI: 80.1-90.9%)
- Negative Percent Agreement (NPA): 99.0% (95% CI: 97.1-99.7%)
Is this test CLIA waived?
Yes, the LifeSign Status Flu A&B Test is CLIA waived for swab specimens, simplifying its use in various clinical settings.
How many tests are included?
The LifeSign Status Flu A&B Test kit contains 25 primary diagnostic tests for the rapid, qualitative detection of Influenza A and B antigens.
In addition to the tests, the box is comprehensively supplied with all necessary components for accurate processing and quality control, including:
- Two free control swabs (one positive and one negative) for Quality Control (QC).
- Flocked nasal swabs designed for improved patient comfort during collection.
- Pre-measured developer solution capsules to enhance accuracy and standardize the testing process.
Does the test kit include a developer solution?
The LifeSign Status Flu A&B Test features a pre-measured developer solution capsule to ensure accurate results and ease of use. This eliminates the need for manual measurements and reduces potential errors.
Is a physician's license required to use this test?
Yes, the LifeSign Status Flu A&B Test is strictly intended for professional laboratory use only.
This is not an at-home test. Administration requires a certified lab facility and necessitates physician’s licensing for compliance and accurate oversight.
Does this test meet FDA performance criteria?
The LifeSign Status Flu A&B Test meets the new FDA reclassification performance criteria, ensuring it adheres to the latest standards for accuracy and reliability.
Does the test detect H1N1?
Yes, the LifeSign Status Flu A&B Test is designed to detect Influenza Type A, Influenza Type B, and specifically H1N1 (Swine Flu).