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 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.

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

Specimen collection and preparation

 

Step 1 

Pain free puncture with safety lancet

Step 2 

Adding light pressure a drop of blood emerge

Step 3 

The drop of blood is collected with the UniSampler™

Step 4 

5 drops of buffer liquid is added to the UniSampler™

Step 5 

“The UniSampler supports the user in the important step of thoroughly mixing sample and sample buffer, required for effective Vitamin D release and later quantification.”

Step 6 

The mix of blood and buffer is placed on the test window (S)

Step 7

The total sample liquid should be 3-4 drops

Step 8

VHC Reader adaptor is placed on top of the test

 

Step 9

The VHC Reader is placed on the adaptor and the program is initiated.

 

Pictogram UniSampler™ Device

 

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

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”

 

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 by our order form – click here

Questions: +45 3131 1925

 

Instructions for use

Download IFU here