Lomina Vitamin D semi-quantitative blood test

Vitamin D deficiency can manifest itself in muscle and bone pain, increased tooth decay, increased fatigue, reduced immunity and sometimes a greater tendency to psychological problems. Get tested with the LOMINA Vitamin D test.

Intended Use:

The Lomina Vitamin D Test is a rapid chromatographic immunoassay for the semi-quantitative detection of 25-hydroxy vitamin D (25(OH)D) in the human body, It is designed for detection from a finger prick sample of whole blood. This test provides a preliminary diagnostic result and can be used to screen for vitamin D deficiency.

Vitamin D test

The vitamin D test is based on the principle of competitive binding immunoassay. During testing, the compound migrates through the membrane where an immunochemical reaction occurs during capillary migration. The membrane is pre-coated with 25-OH vitamin D antigens in the control region (C). The 25-OH vitamin D in the sample is competent to the 25-OH vitamin D in the test region, against a limited amount of anti-25-OH vitamin D antibodies in the conjugate. If all conjugated antibodies are saturated with 25-OH vitamin D in the sample, no coloured band is formed in the test region, indicating a concentration greater than 30 ng/ml. The presence of a visible coloured band in the test area (T) indicates the absence of 25-OH Vitamin D or its presence at a level below 30 ng/ml. The higher the concentration of 25-OH Vitamin D in the sample, the lighter the band in test area T will be. As a check on the procedure, a colored band C will always appear in the control area to indicate that the correct volume of sample has been added and that membrane activation has occurred.

Available Packaging Variants:

Usable Biological Material:

The test is developed and tested for the use of blood samples taken from a finger.

Whole blood

Major Parameters, Characteristics & Limits

Test duration: 10 min

IVD category: IVD other

Reference range: 0-99 years: 75.0 – 250.0 nmol/l

Accuracy very low level (<10ng/mL): 99,90%

Accuracy low level (10-30ng/mL): 94.10%

Accuracy medium level (>30ng/mL): 92.00%

Accuracy TOTAL: 93,80%

Interpretation:

1.Very Low/Low/Medium Vitamin D levels test result:

Very low <10ng/mL:

Two distinctive coloured lines appear (Figure A). One is in the control area (C) and the other should be in the test area (T). The intensity of the line in the test area (T) is the same or darker than the 10 ng/ml line depicted on the ‘line colour intensity card’ supplied with the kit.

Low 10-30ng/mL:

Two coloured lines appear (Figure A). One is in the control area (C) and the other should be in the test area (T). The intensity of the line in the test area (T) is darker than the 30 ng/ml line shown on the colour card supplied with the kit and lighter than the 10 ng/ml line shown on the ‘line colour intensity card’ supplied with the kit.

Medium >30ng/mL:

Two coloured lines will appear (Figure A), one line should always be in the control area (C) and a faint coloured line will appear in the test area (T).

2. High level Vitamin D test result:

High level >50ng/mL:

A single coloured line appears in the control line area (C). No obvious coloured line appears in the test line area (T) (Figure B). If the result is excessive, consultation with a general practitioner is recommended.

3. 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 test. If the problem persists, stop using the test kit immediately and contact your local distributor (Figure C).

Very low, Low and Medium level Vitamin D test result:

High level Vitamin D test result:

Invalid
test result

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Instructions for use (IFU)

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High sensitivity and specificity of tests

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Tested in accredited laboratories

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