A rapid, one step test for the qualitative detection of Helicobacter pylori (H.pylori) antigens in
human feces.
For self-testing in vitro diagnostic use only.
【INTENDED USE】
The H.pylori Antigen Rapid Test (Feces) is a rapid chromatographic immunoassay for the
qualitative detection of H.pylori antigens in human fecal specimens to aid in the diagnosis of
H.pylori infection.
【SUMMARY】
H.pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and
duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including
duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis.1,2 A very
common approach to the diagnosis of H.pylori infection is the serological identification of
specific antibodies in infected patients. The main limitation of serology test is the inability to
distinguish current and past infections. Antibody may be present in the patient’s serum long
after eradication of the organisms.3 Helicobacter pylori (H.pylori) infection underlies gastric
ulcer disease, gastric cancer and duodenal ulcer disease. The disease expression reflects
the pattern and extent of gastritis/gastric atrophy (i.e., duodenal ulcer with non-atrophic and
gastric ulcer and gastric cancer with atrophic gastritis).4
The H.pylori Antigen Rapid Test (Feces) is a rapid chromatographic immunoassay for the
qualitative detection of H.pylori antigens in human fecal specimens, providing results in 10
minutes. The test utilizes antibodies specific for H.pylori antigens to selectively detect
H.pylori antigens in human fecal specimens.
【PRINCIPLE】
The H.pylori Antigen Rapid Test (Feces) is a qualitative, lateral flow immunoassay for the
detection of H.pylori antigens in human fecal specimens. In this test, the membrane is
pre-coated with anti-H.pylori antibody on the test line region of the test. During testing, the
specimen reacts with the particle coated with anti-H.pylori antibody. The mixture migrates
upward on the membrane by capillary action to react with anti-H.pylori antibody on the
membrane and generate a colored line. The presence of this colored line in the test region
indicates a positive result, while its absence indicates a negative result. To serve as a
procedural control, a colored line will always appear in the control line region indicating that
proper volume of specimen has been added and membrane wicking has occurred.
【REAGENTS】
The test contains monoclonal anti-H.pylori antibody coated particles and monoclonal
anti-H.pylori antibody coated on the membrane.
【PRECAUTIONS】
Please read all the information in this package insert before performing the test.
For self-testing in vitro diagnostic use only.
Do not use after the expiration date. Do not reuse the test.
Store in a dry place at 2-30 °C (36-86 °F), avoiding areas of excess moisture. Humidity
and temperature may adversely affect results. If the foil packaging is damaged or has
been opened, please do not use.
Do not eat, drink or smoke in the area where the specimens or kits are handled.
Handle all specimens as if they contain infectious agents. Observe established
precautions against microbiological hazards throughout all procedures and follow the
standard procedures for proper disposal of specimens.
The used test should be discarded according to local regulations.
Wash hands thoroughly before and after handling.
Any serious incident that has occurred in relation to the device shall be reported to the
manufacturer and the competent authority.
Use the test only once. Keep the test upright while testing. Do not move or turn the
test upside down.
Keep out of the reach of children.
The kit must not be frozen or used after the expiration date printed on the package.
【STORAGE AND STABILITY】
The kit can be stored 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.
Note: It is suggested to use the test within one hour after removing it from the foil pouch.
【SPECIMEN COLLECTION AND PREPARATION】
The fecal specimen must be collected in a clean, dry, waterproof container containing no
detergents, preservatives or transport media.
No dietary restrictions are necessary before using the H.pylori Antigen Rapid Test.
【MATERIALS PROVIDED】
Test Cup (with dilution buffer)
Stool Catcher
Package Insert
Dropper
【MATERIALS REQUIRED BUT NOT PROVIDED】
Timer
Specimen Container
【DIRECTIONS FOR USE】
Before performing the test, allow the test, specimen to reach room temperature
(15-30 °C), stool samples must be collected following the instruction below.
1. Wash your hands with soap and rinse with clear water.
2. Collect fecal specimens:
For Solid feces
Solid fecal specimen should be collected in the Stool Catcher or clean collection
containers.
Please use the Stool Catcher, avoiding contamination of the specimen by taking
precautions that the specimen or side of paper containing specimen does not come in
contact with any contaminating objects including toilet cleaners.
For Liquid feces
Collect liquid feces in a clean and dry container.
3. Bring the pouch to room temperature before opening it. Remove the test cup from the foil
pouch and use it as soon as possible. Best results will be obtained if the test is
performed immediately after opening the foil pouch.
4. Process fecal specimens:
For Solid Specimens:
Unscrew the cap of the test cup and take out the specimen collection applicator.
Randomly stab the specimen collection applicator into the fecal specimen in at least 3
different sites. Do not scoop the fecal specimen.
For Liquid Specimens:
Hold the dropper vertically, aspirate fecal specimens, and then transfer 2 drops of the
liquid specimen (approximately 80 µL) into the test cup containing the dilution buffer.
5. Insert the specimen collection applicator back into the test cup and tighten the cap.
6. Shake the test cup for about 10-15 seconds to mix well. Leave the cup for reaction for 2
minutes.
7. Remove the plastic limit strip of the test cup.
8. Put the test cup on a clean and level surface, press the cup body to the bottom and start
the timer.
NOTE: Keep the test cup upright during the test developing. Do not move or turn the test
cup upside down.
9. Read results at 10 minutes. Do not read results after 20 minutes.
