The Influenza A+B Test Cassette is intended for qualitative detection of influenza A and B antigens in nasopharyngeal swab, throat swab or nasal aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.The test result is calculated by Fluorescence Immunoassay Analyzer.
A rapid test for measuringInfluenza Influenza A+B in Swab with the use of Fiatest TM fluorescence Immunoassay Analyzer. For professional in vitro diagnostic use only.
Influenza (commonly known as "flu") is a highly contagious, acute viral infection of the respiratory tract. It is a communicable disease easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus.1 Influenza outbreaks occur each year during the fall and winter months. Type A viruses are typically more prevalent than type B viruses and are associated with most serious influenza epidemics, while type B infections are usually milder. The gold standard of laboratory diagnosis is 14-day cell culture with one of a variety of cell lines that can support the growth of influenza virus.2 Cell culture has limited clinical utility, as results are obtained too late in the clinical course for effective patient intervention. Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a newer method that is generally more sensitive than culture with improved detection rates over culture of 2-23%.3 However, RT-PCR is expensive, complex and must be performed in specialized laboratories.
The Influenza A+B Test cassette (Swab/Nasal Aspirate) qualitatively detects the presence of Influenza A and/or Influenza B antigen in nasopharyngeal swab or throat swab or nasal aspirate specimens, providing results within 15 minutes. The test uses antibodies specific for Influenza A and Influenza B to selectively detect Influenza A and Influenza B antigen in nasopharyngeal swab, throat swab or nasal aspirate specimens.
Refer to Fiatest TM Fluorescence Immunoassay Analyzer Operation Manual for the complete instructions on use of the Test. The test should be conducted in room temperature.
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Turn on the Analyzer power. Then according to the need, select “standard test” or “Quick test” mode.
2. Take out the ID card and insert it into the Analyzer ID Card Slot.
3. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
4. Place the Extraction Tube in the workstation. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add 10 drops of extraction reagent (Approx. 400ul) to the Extraction Tube.
5. Place the swab specimen in the Extraction Tube. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab.
6. Remove the swab while squeezing the swab head against the inside of the Extraction Tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol.
7. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface.
8. Add three drops of the solution (approx.120μL) to the sample well and then start the timer.
9. There are two test modes for Fiatest TM Fluorescence Immunoassay Analyzer, Standard Test mode and Quick Test mode. Please refer to the user manual of Fiatest TM Fluorescence Immunoassay Analyzer for details.
“Quick test” mode: After 15 minutes of adding sample, Insert the test cassette into the Analyzer, click “QUICK TEST”, fill the test information and click "NEW TEST" immediately.
The Analyzer will automatically give the test result after a few seconds.
“Standard test” mode: Insert the test cassette into the Analyzer immediately after adding specimen, click “STANDARD TEST”, fill the test information and click "NEW TEST" at the same time, The Analyzer will automatically countdown 15 minutes. After the countdown, the Analyzer will give the result at once.
