Who Uses This Product? Clinics that are currently using either the Sofia Fluorescent Immunoassay Analyzer or the Sofia 2 Fluorescent Immunoassay Analyzer.
Why They Love This Product: It has a short training time and low learning curve, and results are delivered in as little as 3 minutes for a positive and 15 minutes for a negative. The test can be administered in three different methods, with each kit containing all the required implements. It's shelf-stable for two years at room temperature, saving refrigerator space.
Sofia RSV FIA Test Overview
The Sofia RSV FIA Test is a testing system designed to identify the RSV virus in individuals 19 years of age and under. Results are produced in about 3 minutes in cases of a positive result and 15 minutes in cases of a negative result, allowing a patient to be assessed, diagnosed, and treated in one visit. Results are color-coded and binary, providing an unambiguous positive or negative.
This kit has a very quick learning time and is performed in a total of three steps, reducing the chance of contamination or procedural error. Due to the simplicity of the testing protocol, the technician is not required to monitor the test for the duration of the time it takes to get results. Each test cassette has a barcode so it can be tracked by the Sofia machines, thereby reducing the risk of error. The test for Respiratory Syncytial Virus is CLIA Waived for those 7 and under.
Is the RSV Test CLIA Waived?
The test kit (Quidel 20260) has been designated by the FDA as CLIA Waived when administered to children age 7 and under. All laboratories in the United States that obtain, handle, or test human tissue or materials must meet the standards set by the Clinical Laboratory Improvement Amendments of 1988, or CLIA for short. When a test is designated as CLIA Waived, it has been determined that the test consistently produces accurate results while also having a simple test protocol.
How It Works
The test uses immunofluorescence technology to confirm or deny the presence of RSV. This test is performed by obtaining a sample from the individual and then placed within the cassette. This cassette is then placed in the analyzer. Mouse monoclonal anti-RSV is then introduced to the sample. If there is RSV present in the sample, a reaction will occur and glow under fluorescent light, signaling a positive result. This test is highly accurate and can ascertain and display a positive result in three minutes or less. A negative takes 15 minutes or less. For testing for RSV without a Sofia or Sofia 2, check out the QuickVue RSV Test from Quidel.
Features and Benefits
What Comes in the Box? (25-Test Kit)
- 25 individually packaged cassettes
- 25 reagent tubes
- 25 reagent solution vials with salt solution
- 25 sterile nasopharyngeal swabs
- 25 large pink fixed volume pipettes
- 25 small, clear fixed volume pipettes
- 1 RSV-positive control swab coated with non-infectious RSV antigen
- 1 negative control swab coated with heat-inactivated, non-infectious Streptococcus C antigen
- Package insert
- Quick Reference Instructions
- 1 QC Card (located on kit box
- Printer paper
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- Sofia Influenza A+B test kit tests for presence of influenza type A and B using the Sofia or Sofia 2 machine.
Specifications
Manuals and Documents
Sales Sheet contains product information.- Test Package Insert is documentation included in the test kit.
- Safety Data Sheet is documentation containing the safety data for all the materials used.
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