H.pylori antigen rapid test (stool)

Product Description

The H. pylori Antigen Card Test (Feces) is a rapid chromatographic immunoassay for the qualitative detection of H. pylori antigens in human stool specimens.

Indications

The H. pylori Antigen Card Test (Feces) is a rapid chromatographic immunoassay for the qualitative detection of H. pylori antigens in human stool specimens, providing results in 10 minutes. The test uses antibodies specific for H. pylori antigens to selectively detect H. pylori antigens in human stool specimens.

The H. pylori Antigen Card Test (Feces) is a qualitative lateral flow immunoassay for the detection of H. pylori antigens in human stool specimens. In this test, the membrane is precoated with anti-H. pylori on the test line region. During the test, the sample reacts with the anti-H. pylori antibody-coated particle. The mixture migrates upward on the membrane by capillary action to react with the anti-H. pylori on the membrane, generating a colored line. The presence of this colored line in the test line 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 an adequate volume of sample has been added and membrane wicking has occurred.

Method Instructions for Use

• Wash your hands with soap and rinse with water.
• To Collect Fecal Samples
  The stool sample must be collected on stool collection paper or in clean collection containers. Use stool collection paper, avoiding contamination of the sample by taking precautions to ensure that the sample or the side of the paper containing the sample does not come into contact with contaminants, including toilet cleaners.
• To Process Fecal Samples
  Unscrew the cap of the sample collection tube, then randomly insert the sample collection applicator into the stool sample in at least 3 different places. Do not collect the stool sample.
  Screw and tighten the cap on the sample collection tube, then shake the sample collection tube vigorously to mix the sample and extraction buffer for 2 minutes.
• Bring the pouch to room temperature before opening. Remove the H. pylori test from the foil pouch and use it as soon as possible. Best results are obtained if the test is performed immediately after opening the foil pouch.
• Open the cap of the sample collection tube and break the tip. Invert the sample collection tube and transfer 2 full drops of the extracted sample into the sample well (S) of the test card, then start the timer. Avoid trapping air bubbles in the sample well (S).
• Read the results after 10 minutes. Do not read the results after 20 minutes.

Reading the Results

• Positive: * Two lines appear. Both the T (test) line and the C (control) line appear. This result means that H. pylori antigen is present in your stool and you should consult a doctor. *Note: The intensity of the color in the test (T) line region will vary depending on the concentration of H. pylori antigen in the sample. Therefore, any shade of color in the test (T) line region should be considered positive.
• Negative: A colored line appears in the control (C) line region. No line appears in the test line region (T).
  This result means that the presence of H. pylori antigen in the stool is undetectable.
• Invalid: The control line does not appear. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue use of the test kit immediately and contact your local distributor.

Warnings

• For in vitro diagnostic self-testing only. Do not use after the expiration date.
• Do not eat, drink, or smoke in the area where the specimens or kits are handled.
• A clean container to collect the stool sample.
• Strictly follow the indicated time.
• Use the test only once. Do not disassemble or touch the H. pylori test window.
• The kit should not be frozen or used after the expiration date printed on the package.
• The used test must be disposed of according to local regulations.
• Keep out of reach of children.

Limitations

• The H. pylori Antigen Card Test (Feces) is for in vitro diagnostic self-testing only. The test should be used to detect H. pylori antigens in stool specimens only. Neither the quantitative value nor the rate of increase in H. pylori antigen concentration can be determined by this qualitative test.
• The H. pylori Antigen Card Rapid Test (Feces) will only indicate the presence of H. pylori in the specimen and should not be used as the sole diagnostic criterion for H. pylori as a causative agent for peptic or duodenal ulcers.
• As with all diagnostic tests, all results should be interpreted in conjunction with other clinical information available to the physician.
• If the test result is negative and clinical symptoms persist, further testing using other clinical methods is recommended. A negative result never precludes the possibility of H. pylori infection.
• Following some antibiotic treatments, the concentration of H. pylori antigens may decrease to a concentration below the minimum detection level of the test. Therefore, diagnosis should be made with caution during antibiotic treatment.

Storage

The kit can be stored at room temperature or refrigerated (2-30°C). The test device is stable until the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. Do not freeze. Do not use after the expiration date.

Format

H. pylori test, sample collection tube with extraction swab, package insert, stool collection paper.