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 is recommended to further confirm the diagnostic test results.

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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.

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

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

5. 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

10 x Tests and a Reader, ready to use
25 x Tests and a Reader, ready to use
50 x Tests and a Reader, ready to use

Order & QA

Order here