H. pylori Antigen Rapid Test Kit

The H. pylori Antigen Rapid Test Kit is a qualitative immunoassay designed to detect the presence of Helicobacter pylori (H. pylori) antigens in human stool samples. This test kit offers a convenient and reliable method for diagnosing H. pylori infection.

Intended Use: The H. pylori Antigen Rapid Test Kit is intended for healthcare professionals and laboratory use to aid in the diagnosis of H. pylori infection. It is not meant for self-testing at home.

Principle: The H. pylori Antigen Rapid Test Kit utilizes the lateral flow immunoassay principle. The test employs specific antibodies that selectively detect H. pylori antigens in the stool sample. The test device contains a membrane strip pre-coated with monoclonal antibodies against H. pylori antigens and colored particles conjugated with anti-H. pylori antibodies. When the stool sample is added to the test device, any H. pylori antigens present in the sample bind to the conjugate, forming colored lines in the test regions. The control line serves as a procedural control to validate the test results.

Storage and Stability:

  • The H. pylori Antigen Rapid Test Kit should be stored at room temperature (2-30ºC).
  • The kit components are stable through the expiration date printed on the sealed pouch.
  • The test devices must remain in the sealed pouches until use.
  • Do not freeze the test kits.
  • Do not use beyond the expiration date.

Precautions:

  • For in-vitro diagnostic use only.
  • Use the test kit in a well-ventilated area.
  • Handle all specimens and test components as if they contain infectious agents.
  • Follow standard precautions for the disposal of used test components.
  • Wear protective clothing, such as laboratory coats and disposable gloves, when handling specimens.
  • Read the instructions carefully before performing the test.

Procedure:

  • Allow the test cassettes and specimens to equilibrate to room temperature (15-30ºC).
  • Open the sealed pouches and remove the test cassettes.
  • Collect a small stool sample and add it to the sample well on each test devic.
  • Wait for the colored lines to appear in the result windows within the specified time.
  • Interpret the results according to the instructions provided.

Interpretation of Results:

  • Positive Result: The presence of both the control line and the test line indicates a positive result, suggesting the presence of H. pylori antigens in the sample.
  • Negative Result: Only the control line appears, but the test line is absent. This indicates a negative result, suggesting the absence of H. pylori antigens in the sample.
  • Invalid Result: If no lines appear, or if only the test line appears without the control line, the result is invalid. Repeat the test with new kits.

Limitations:

  • The H. pylori Antigen Rapid Test Kit is a screening test and should be confirmed by additional testing methods if the results are positive or inconsistent with clinical evidence. False-negative or false-positive results may occur due to various factors, including improper sample collection, storage, or handling. Results should be interpreted in conjunction with clinical information and other diagnostic findings.