Lomina Calprotectin test

Calprotectin is a protein released by a type of white blood cell called a neutrophil. When there is inflammation in the gastrointestinal (GI) tract, neutrophils move to the area and release calprotectin, resulting in an increased level in the stool. This test measures the level of calprotectin in stool as a way to detect inflammation in the intestines.

Intended Use:

The Lomina Calprotectin Test is a rapid chromatographic immunoassay for the qualitative detection of calprotectin in human stool samples that can be useful for the diagnosis of inflammatory gastrointestinal diseases.

Calprotectin test:

The Lomina Calprotectin Test is a qualitative lateral flow membrane immunoassay for the detection of human fecal occult blood. The membrane is pre-coated with an anti-calprotectin antibody in the test area of the strip. A mixture of stool and reagent migrates across the membrane where an immunochemical reaction occurs during capillary migration and reacts with the anti-calcprotectin on the membrane to form a coloured strip. The presence of the coloured band in the test area indicates a positive result, while its absence indicates a negative result. As a check on the procedure, a coloured band always appears in the control area, indicating that the correct volume of sample has been added and membrane activation 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: 5 min

IVD category: IVD other

Sensitivity: 97.8% (95%CI: 93.7%-99.5%)

Specificity: 99.0% (95%CI*: 96.4%-99.9%)

Accuracy: 98.5% (95%CI*: 96.6%-99.5%)

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 Calprotectin 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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High sensitivity and specificity of tests

Quick test
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Tested in accredited laboratories

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