Avian Influenza Virus H5 (AIV H5) Antigen Rapid Test
(Laryngotracheal secretion/Feces)
VIAIH-507
INTENDED USE
The Avian Influenza Virus H5 (AIV H5) Antigen Rapid Test
(Laryngotracheal secretion/Feces) is a sandwich lateral flow
immunochromatographic assay for qualitative detection avian
influenza H5 virus in avian trachea and feces to auxiliary
diagnosis of avian influenza H5 virus infection, such as chicken,
bird and duck.
For veterinary use only.
PRINCIPLE
The Avian Influenza Virus H5 (AIV H5) Antigen Rapid Test is based
on sandwich lateral flow immunochromatographic assay. The test has
a testing window with an invisible T (test) zone and C (control)
zone. During testing, the liquid will laterally flow on the surface
of the test strip. If there is enough avian influenza H5 virus
antigens in the sample, a visible T line will appear. The C line
should always appear after a sample is applied, indicating a valid
result. By this means, the test can accurately indicate the
presence of avian influenza H5 virus antigen in the sample.
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or
refrigerated (2-30 °C). The test is stable through the expiration
date printed on the sealed pouch. The test must remain in the
sealed pouch until use. DO NOT FREEZE.
Do not use beyond the expiration date.
PRECAUTIONS
Do not use after the expiration date. Do not reuse the test kit.
Handle all specimens as if they contain infectious agents.
Observe established precautions against microbiological hazards
throughout testing and follow the standard procedures for proper
disposal of specimens.
Wear disposable gloves and eye protection when specimens are
being tested.
Humidity and temperature can adversely affect results.
Do not remove test from its pouch until immediately before use.
Do not mix components from different lot and different products.
Please ensure that an appropriate amount of samples are used for
testing. Too much or too little sample size may lead to deviation
of results.
MATERIALS
Materials Provided
• Test Cups (with dilution buffer)
• Swabs
• Package Insert
Materials Required But Not Provided
• Timer
DIRECTIONS FOR USE
Allow the test and specimen to equilibrate to room temperature
(15-30 °C) prior to testing.
1. Remove the test from the foil pouch and use it as soon as
possible. Best results will be obtained if the assay is performed
within one hour.
2. Unscrew the cap of the test cup.
Collect animal’s laryngotracheal secretion with a swab or collect
animal’s feces with the swab from the anus. Insert the wet swab
into the test cup and mix well. Remove the swab.
Collect animal’s feces with the collection applicator on the
ground. Randomly stab the specimen collection applicator into the
specimen in at least 3 different sites to collect approximately 50
mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal
specimen.
3. Insert the specimen collection applicator back into the test cup
and tighten the cap.
4. Shake the test cup for about 10-15 seconds to mix well. Leave
the cup for reaction for 2 minutes.
5. Remove the plastic limit strip of the test cup.
6. Put the test cup on a clean and level surface, press the cup
body from the top to the bottom and start the timer.
Note: Keep the test upright while testing. Do not move or turn the
test upside down.
7. Read the result at 10 minutes. Do not interpret results after 15
minutes.
INTERPRETATION OF RESULTS
Positive: The presence of both C line and T line, no matter T line
is clear or
vague.
Negative: Only clear C line appears.
Invalid: No colored line appears in C zone, no matter whether T
line appears.