Cryptosporidium Antigen Rapid Test
(Feces)
Package Insert
REF VICR-607
INTENDED USE
The Cryptosporidium Antigen Rapid Test (Feces) is a sandwich lateral flow immunochromatographic assay for the qualitative detection of Cryptosporidium antigens in animal’s feces.
For veterinary use only.
PRINCIPLE
The Cryptosporidium 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 Cryptosporidium 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 Cryptosporidium antigens 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 feces with the swab from animal’s 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.
