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H. pylori Ag Rapid Test CE Marking


Product Number: RAPG-HPAg-001

Pack size

10 tests

Product Description

The Biopanda H. pylori Antigen Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of H. pylori antigens in human faeces specimens to aid in the diagnosis of H. pylori infection.

Test Attributes

  • Human faecal samples may be used for testing
  • Results available in only 10 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting to diagnose helicobacter pylori infections

Test Procedure

  1. Remove the cassette from its foil wrapping and place on a flat, clean surface.
  2. Holding the sample collection device upright, carefully break off the tip of collection device.
  3. Squeeze 2 drops (~80 μl) of the sample solution in the specimen well of the cassette, as in the illustration.
  4. Read the test results at 10 minutes.
  5. Results read after 20 minutes are considered invalid.
H. pylori Ag Rapid Test H. pylori Ag Rapid Test

Principle

The Biopanda H. pylori Antigen Rapid Test Cassette is a qualitative, lateral flow immunoassay for the detection of H.pylori antigens in human faecal specimens. In this test, the membrane is pre-coated with anti-H. pylori antibodies on the test line region of the test. During testing, the specimen reacts with the particles coated with anti-H. pylori antibodies. The mixture migrates upward on the membrane by capillary action to react with anti-H. pylori antibodies on the membrane and generates a coloured line. The presence of this coloured line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a coloured line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Performance Characteristics

  • Relative Sensitivity: >99.9%
  • Relative Specificity: 98.4%
  • Accuracy: 99.1%

Storage Conditions

+2 - 8 °C


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