The H. pylori Antigen Rapid Test (Feces) is a rapid chromatographic immunoassay for the
qualitative detection of H. pylori antigens human feces 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 feces specimens, providing results in 10
minutes. The test utilizes antibodies specific for H. pylori antigens to selectively detect H. pylori
antigens in human feces specimens.
【PRINCIPLE】
The H. pylori Antigen Rapid Test (Feces) is a qualitative, lateral flow immunoassay for the
detection of H. pylori antigens in human feces 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 professional use only. For 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. 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.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when
specimens are assayed.
• The used test should be discarded according to local regulations.
• Humidity and temperature may adversely affect results.
• 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.
• The kit must not be frozen or used after the expiration date printed on the package.
• Components provided in the kit are approved for use in the H. pylori Antigen Rapid Test. Do not
use any other commercial kit component.
【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 feces specimen must be collected in clean, dry, waterproof container containing no
detergents, preservatives or transport media.
• No dietary restrictions are necessary before using the H. pylori Antigen Rapid Test Rapid Test.
• Bring the necessary reagents and feces specimen to room temperature before use.
• If specimens are to be shipped, they should be packed in compliance with local regulations
covering the transportation of etiologic agents.
【MATERIALS PROVIDED】
Test Cups (with dilution buffer)
Package Insert
【MATERIALS REQUIRED BUT NOT PROVIDED】
Timer
Centrifuge
Specimen Containers
Droppers
【DIRECTIONS FOR USE】
Before performing the test, allow the test specimen and cup 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:
Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry specimen collection
container. Best results will be obtained if the assay is performed within 6 hours after collection.
Specimen collected may be stored for 3 days at 2-8 °C if not tested within 6 hours. For long
term storage, specimens should be kept below -20 °C.
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 to collect approximately 50 mg of feces (equivalent to 1/4 of a pea). 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 from the top to the bottom and
start the timer.
NOTE: If the specimen does not migrate (presence of particles), open a new test cup, repeat step
4 and centrifuge the diluted specimen contained in the test cup with a clean tube. Pipette
1-1.5 mL of supernatant, dispense into the test cup and insert the specimen collection applicator
back into the test cup and tighten the cap. Continue from step 7-8 onwards in the above
instructions for use and start the timer.
9. Read results at 10 minutes. Do not read results after 20 minutes.
