- Intended for the rapid, qualitative detection and differential diagnosis of acute influenza type A and type B viral infections
Overview:
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Rapid Lateral Flow Immunoassay:
- Rapid diagnostic test that uses a dipstick format
- Works by detecting specific antigens (proteins) from the influenza virus
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CLIA Waived:
- Means the test is simple to perform and has a low risk of erroneous results
- Makes it suitable for use in a variety of healthcare settings, including physician's offices, clinics, and other point-of-care locations, often with minimal training
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Two-Color Endpoint:
- Results are easy to interpret with two distinct colors appearing on the test strip for positive results and a clear control line
Key features and benefits:
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Fast Results:
- Provides results in 10 minutes or less, allowing for quick patient management decisions (e.g., prescribing antivirals)
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Multiple Sample Types:
- Can be used with nasal swab, nasopharyngeal swab, nasal wash, or nasal aspirate specimens
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Easy to Use:
- Features a simple procedure, often described as having only one step for nasal wash/aspirate samples and three steps for nasal swab samples, with minimal hands-on time (around 30 seconds to 1 minute).
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Room Temperature Storage:
- Kits can be stored at room temperature (15°C to 30°C / 59°F to 86°F) and have a long shelf life (up to 24 months from the date of manufacture), making them convenient for office or lab use
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Internal Controls:
- Includes built-in procedural controls to ensure the test is working correctly
- External controls (positive A, positive B, and negative) are also included in the kit for quality control
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Aid in Diagnosis:
- While it provides a rapid result, negative results should ideally be confirmed by cell culture or an FDA-cleared molecular assay, and they should not be the sole basis for treatment decisions
- Test does not detect influenza C antigens
Contents:
- 25 Test Strips (individually pouched)
- 25 Reagent Tubes (containing lyophilized buffer)
- 25 Reagent Solution vials
- 25 Disposable Pipettes
- 25 Sterile Nasal Swabs (or sometimes nasopharyngeal swabs are sold separately)
- Positive Influenza Type A Control Swab
- Positive Influenza Type B Control Swab
- Negative Control Swab
- Package Insert (instructions for use)
- Procedure Card