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.