The Influenza A+B Test Cassette (Swab/Nasal Aspirate) is intended for in vitro 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.
【SUMMARY】
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.
【PRINCIPLE】
The Influenza A+B Test Cassette (Swab/Nasal Aspirate) detects Influenza A and Influenza B
nucleoproteins based on Fluorescence Immunoassay. The sample moves through the strip from
sample pad to absorbent pad. If the specimen contains Influenza A and Influenza B
nucleoproteins, it attaches to the fluorescent microspheres-conjugated anti- Influenza A and/or
Influenza B antibodies. Then the complex will be captured by the capture antibodies coated on
the nitrocellulose membrane (Test line). The concentration of Influenza A and/or Influenza B in
the sample correlates with the fluorescence signal intensity captured on the T line, which can be
scanned by Novatrend Plus Fluorescence Immunoassay Analyzer. The testing result of Influenza
A and Influenza B will display on the Novatrend Plus Fluorescence Immunoassay Analyzer screen.
【REAGENTS】
The test cassette contains anti-Influenza A and B conjugated fluorophores and anti- Influenza A
and B coated on the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if the foil
pouch is damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection container for
each specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests are handled. Handle all
specimens as if they contain infectious agents. Observe established precautions against
microbiological hazards throughout the procedure and follow standard procedures for proper
disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and
eye protection when specimens are assayed.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The Influenza A+B Test Cassette should only be used with the FIATEST GO Analyzer by
approved medical professionals.
【STORAGE AND STABILITY】
1. The kit should be stored at 4-30 °C until the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the kit from contamination. Do not use if
there is evidence of microbial contamination or precipitation. Biological contamination of
dispensing equipment, containers or reagents can lead to false results.
【SPECIMEN COLLECTION AND PREPARATION】
Preparation
Before performing the test, please make sure that all components are brought to room
temperature (15-30 °C). Cold buffer solution or moisture condensation on the membrane can
lead to invalid test results.
Sample Handling
• Nasopharyngeal swab sample
1.Insert a sterile swab into the nostril of the patient, reaching the surface of the posterior
nasopharynx.
2.Swab over the surface of the posterior nasopharynx 5-10 times.
• Throat swab sample
Insert a sterilized swab into pharynx and collect mucoepidermis mainly wiping flare region of
post-pharyngeal wall and palatine tonsil several times, and be careful not to make saliva attach
to the swab.
• Nasal aspirate
Connect an aspiration catheter to an aspiration trap that is attached to an aspiration device,
insert the catheter to nasal cavity from a nostril, start the aspiration device and then collect nasal
aspirate sample. Dip a sterilized swab into the collected nasal aspirate sample and make the
specimen cling to the swab.
【MATERIALS】
Materials Provided
• Test Cassettes
• Extraction Reagent
• Extraction Tubes
• Sterile Swabs
• Package Insert
• Workstation
• Extraction Tube Tips
• ID card
Materials Required But Not Provided
• Timer
• FIATEST GO Fluorescence Immunoassay Analyzer
【DIRECTIONS FOR USE】
Refer to Novatrend Plus 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. 400 μL) 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.120 μL) to the sample well and then start the
timer.(Follow the illustration as below)
9. There are two test modes for Novatrend Plus Fluorescence Immunoassay Analyzer, Standard
Test mode and Quick Test mode. Please refer to the user manual of Novatrend Plus
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.
