Lomina Fecal Occult Blood (FOB) test

The Lomina Fecal Occult Blood (FOB) Test is a rapid chromatographic immunoassay for the qualitative detection of human fecal occult blood. In addition, unlike guaiac tests, the accuracy of the test is not affected by the patients’ diet.

Intended Use:

The Lomina Fecal Occult Blood (FOB) Test is a rapid test that qualitatively detects low levels of occult blood in the stool. The test uses a double antibody principle that selectively detects fecal occult blood at concentrations of 50 ng/ml or higher, or 6 μg/g stool. In addition, unlike guaiac tests, the accuracy of the test is not affected by the patients’ diet.

Fecal Occult Blood FOB test:

Many diseases can cause occult blood in feces. This is also known as faecal occult blood (FOB), human occult blood or human haemoglobin. In the early stages of gastrointestinal problems such as colon cancer, ulcers, polyps, colitis, diverticulitis and fissures, there may be no visible symptoms but only occult blood. Traditional guaiac-based methods do not have sufficient sensitivity and specificity, plus they have dietary restrictions before testing.
  The Lomina Fecal Occult Blood (FOB) Test is a qualitative lateral flow membrane immunoassay for the detection of human occult blood in stool. The membrane is pre-coated with anti-hemoglobin 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-hemoglobin on the membrane to form a colored band. 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: 98.40% (95%CI: 91.60%-99.99%)

Specificity: 99.30% (95%CI*: 97.80%-99.80%)

Accuracy: 99.70% (95%CI*: 97.80%-99.80%)

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 FOB 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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