Test Vitamin D

Point-of-care
Quantitative Vitamin D Test

The VHC Quantitative Vitamin D Test allow healthcare professionals to measure “point of care” vitamin D in a few minutes. 

The test is an immunochromatography-based one step in vitro test. It is designed for the quantitative determination of total 25-hydroxy Vitamin D (25-OH Vitamin D) in human finger-prick blood. This assay provides a preliminary diagnostic test result and can be used for screening of Vitamin D deficiency.

VHC Vitamin-D Quantitative Vitamin D Test utilizes the principle of immunochromatography, a unique two-site “Sandwich” immunoassay on a membrane.

The test employs a very “Exclusive” pair of anti-25-OH Vitamin D Monoclonal Antibodies; one conjugated with colloidal gold and another one immobilized on the solid phase. This will selectively detect Vitamin D with a high degree of sensitivity and specificity.

The liquid chromatography with tandem mass spectrometry (LC-MS/MS) assays or other quantitative immunoassays are recommended to further confirm the diagnostic test results.

Using a modern rapid test, such as the VHC Vitamin-D, a person’s current precise blood level can be determined on the spot. All that is required is a small drop of blood from the fingertip. This test provides prompt information as to whether and to which extent there is a vitamin D deficiency, and advice can be given there and then.

The test result can be used to calculate the replenishment required to get up to a good vitamin D level. As the testing quantifies the deficit, the dosage to raise the level can be adjusted and reduced during the replenishment phase without risk of overdosing so that the optimum level for proper immune system activity is reached within a few weeks.

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Perhaps more important
than ever before

Vitamin D and the immune system 

It has been known for some years that the effects of vitamin D go far beyond optimum control of the calcium metabolism and the associated building and maintaining of healthy bones. In fact, it regulates the activity of over 1,000 genes in the human body. It has a key impact on the activity of many body functions, including the immune system.

The positive influence of an optimized vitamin D level on the immune system has been scientifically proven and convincingly substantiated by clinical trials. Consequently, drawing attention to this health-promoting characteristic by printing the phrase “Vitamin D supports normal immune function” on supplement packaging is permitted.

Bacterial and viral infections

Today, our modified lifestyle, involving activities independent of seasonal change, greater mobility, and regular new “external contacts”, is resulting in many people becoming more vulnerable to bacterial and viral infections with pathogens that are new to their immune system, particularly during the winter season.

The readiness and responsiveness of our entire immune system depend on an adequate vitamin D level in the blood. A recent study found that due to the fact that the body’s own production of vitamin D in the skin is often only ensured to a limited extent, some 80% of the German population are no longer building up a sufficient buffer to prevent a critical drop in the vitamin D level in winter.

Supplements may reduce risk

However, if they take a supplement during the winter season to keep their body’s vitamin D at an optimum level to maintain the responsiveness of the immune system, this minimizes their susceptibility to colds and the risk of contracting genuine flu (influenza). In clinical studies, scientists succeeded in reducing the general risk of contracting a respiratory disease by 35% through vitamin D supplementation.

Absorption of vitamin D via the digestive tract differs from person to person and depends on several factors. It, therefore, makes sense to check after 2–3 months which level has been achieved with the replenishment phase and the recommended maintenance dosage thereafter. Subsequently, the vitamin D level should be checked at least once a year to make sure that it is kept at a good level or to allow adjustment of the required dosage, if appropriate.

Quantitative

Vitamin D test for in vitro diagnostics only

Vitamin D easy to use test

Pain free collection and simple process to get a measurement of the patients Vitamin D level.

Chairside

Chairside test that allow you to give the patient an indication of their Vitamin D level, as you speak.

Flexible

Flexible reader technology enable read outs of several different tests

Performance characteristics

 

Sensitivity

The sensitivity of VHC Vitamin-D Quantitative Vitamin D Test is 3ng/ml (7.5nmol/l). The sensitivity was determined by calculating the mean plus 3.3 times of standard deviation of twenty Vitamin D-free serum tests.

Specificity

30 Vitamin D free serum samples were tested and all showed negative results; suggesting 100% specificity. No interference and cross reactivity was observed with Bilirubin, Triglycerides, Cholesterol, Vitamin B12 and Vitamin C.

Accuracy

The accuracy of VHC Vitamin-D Quantitative Vitamin D Test was evaluated using human finger-prick blood samples in comparison with a reference 25OH Vitamin D ELISA assay using corresponding serum samples. The comparison result showed a linear regression with slope of 1.02 and Correlation Coefficient of 92%. In conclusion, VHC Vitamin-D Quantitative Vitamin D Test results of human blood samples showed good agreement with the ELISA results of corresponding serum samples.
The accuracy of VHC Vitamin-D Quantitative Vitamin D Test was also evaluated using 20 serum samples in comparison with LC-MS/MS Assay (“Gold Standard” for 25-OH Vitamin D measurement). The comparison result showed a linear regression with the slope of 0.98 and Correlation Coefficient of 98%. In conclusion, VHC Vitamin-D Quantitative Vitamin D Test results agree closely to the true values generated from LC-MS/MS assay.

 

Precision

Sample No of replicates Mean ng/ml Standard deviation Coeficient Variation (CV)
Serum 20 40.4 3.1 7.6%
Blood-1 10 33 2.5 7.6%
Blood-2 10 38.7 3.9 10.1%

The complete package needed

 

Test Materials Provided

1. VHC Vitamin-D Quantitative Vitamin D Test device

2. Sample Buffer 3ml – 6ml pr Box

3. UniSampler™ Devices equal number of tests in box

4. RFID Card for identification and calibration – 1

5. Instructions for use – 1

6. Lancets – 1

Blood collection package

1. 200 Lancets

2. 200 Alcohol Swab

The package can be ordered here

VHC TEST Reader

The Reader is sold separately or as part of a starter kit package.

It´s small, battery driven and easy to handle.

Get started testing Vitamin D “Point of Care”

 

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Start-up packages

  1. 10 x Tests and a Reader, ready to use
  2. 25 x Tests and a Reader, ready to use
  3. 50 x Tests and a Reader, ready to use

 

Order & QA

Order online in our shop

Questions or comments, please call: +45 3131 1925

 

Instructions for use

Download IFU here

 

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