Lomina Helicobacter pylori antigen test

Lomina Helicobacter pylori stool antigen test. This is the most common stool test to detect H. pylori. The test looks for proteins (antigens) associated with H. pylori infection in the stool.

Intended Use:

The Lomina H.pylori Antigen Test is a rapid chromatographic immunoassay for the qualitative detection of H.pylori antigens in human feces, providing results within 10 minutes. The test uses antibodies specific for H. pylori antigens to selectively detect Helicobacter pylori antigens in human stool samples.

Helicobacter pylori antigen test:

The Rapid H. pylori antigen test is a qualitative lateral flow immunoassay for the detection of H. pylori antigens in human stool samples. In this test, the membrane is pre-coated with antibodies against H. pylori in the test line area. During testing, the spectrum of the imane reacts with the particle coated with anti-H. pylori antibodies. The mixture on the membrane migrates upwards in a capillary fashion, where it reacts with the H. pylori antibodies on the membrane to form a coloured line. The presence of this coloured line in the tested area indicates a positive result, while its absence indicates a negative result. If the sample contains H. pylori antigen, a coloured line appears in the tested area, indicating a positive result. If the sample does not contain H. pylori antigen, a coloured line will not appear in this area, indicating a negative result. As a check on the procedure, a coloured line always appears in the control line area, indicating that the correct volume of sample has been added and membrane loading has occurred.

Available Packaging Variants:

Usable Biological Material:

The test is developed and tested using stool samples.

Stool sampling

Major Parameters, Characteristics & Limits

Test duration: 10 min

IVD category: IVD other

Sensitivity: 98.80% (95%CI: 95.80%-99.90%)

Specificity: 98.60% (95%CI*: 96.80%-99.50%)

Accuracy: 98.60% (95%CI*: 96.80%-99.50%)

Interpretation:

A. Negative test result:

A single coloured line appears in the control area (C). No coloured line appears in the test area (T).

B. Positive test result:

Two coloured lines appear. One colour line should be in the control area (C) and the other colour line should be in the test area (T). The intensity of the colour in the test area (T) will vary depending on the concentration of Helicobacter pylori present in the sample. Therefore, any shade of colour in the test area (T) should be considered positive.

C. Invalid test result:

The control line is not displayed. The most likely cause of control line failure is insufficient sample volume or incorrect procedures. Check the procedure and repeat the test with a new cartridge. If the problem persists, stop using the test kit immediately and contact your local distributor.

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Instructions for use (IFU)

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CE Certificate

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High sensitivity and specificity of tests

Quick test
evaluation

Tested in accredited laboratories

Simple
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