The quantitative Vitamin D test (with Cube Reader) is designed for use by medical professionals frequently confronted with (consequences of) Vitamin D status, e.g. dieticians, GPs, occupational health specialists, physicians in geriatric care, personal trainers etc.

Are you a consumer/patient and would you you like to have your blood tested for Vitamin D, please contact your care givers.

This test requires 10 µl of whole blood from a fingerprick. The required lancet and micro collection tube are included in the package.

  • The sample is applied to a test cartridge, the sample will migrate to the test fields.
  • Ater 15 minutes, the Cube Reader will provide a number, the Vitamin D concentration in the blood

 

TEST PRINCIPLE

Quick Profile™ Vitamin D Test utilizes the principle of Immunochromatography, a unique two-site “Sandwich” immunoassay on a membrane.  The test employs an  “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.

As the test sample flows through the membrane assembly within the test device, the colored anti-25-OH Vitamin D-colloidal gold conjugate complexes with 25-OH Vitamin D from the sample.  This complex moves further on the membrane by the capillary action to the test region (T) where it is immobilized by the anti-25-OH Vitamin D coated on the membrane leading to formation of a pink / purple colored band, which confirms a positive test result. The intensity of colored band in the test line region is 25-OH Vitamin D concentration-dependent, higher the concentration of 25-OH Vitamin D in the tested sample, the stronger the colored band is. A control line is present in the test window to work as procedural control. This colored band should always appear on the control line region (C) if the test device is stored in good condition and the test is performed appropriately.

The test cartridges are produced by Lumiquick Diagnostics Inc. in Santa Clara, California, United States.

 

BLOOD COLLECTION, USING THE UNISTIK 3® SAFETY LANCET 

unistik-kleinStep 1: turn the lancet cap and dispose. DO NOT PULL

 

 

 

unistik-prikkenStep 2: Push the lancet platform firmly against the sampling site and push the release button.

The lancet will automatically be retracted into the device.

 

Watch the instruction video: Unistik 3® safety lancet.

 

 

SAMPLE COLLECTION AND TEST PREPARATION

Step 1: Prepare collection tube by adding 5 drops of sample buffer into the collection tube

Step 2: Gently touch the tip of the Blood Collector to blood droplet.

Capillary action will completely fill with 10µl of blood and stop.

Step 3: Fully insert blood into Collection Tube and push firmly to close tightly.

Step 4: Vigorously shake the Sampler for 3-4 times to ensure complete mixing of blood with buffer.

DO NOT INVERT THE SAMPLER.

Step 5: Remove the cap of the sampler

Step 6: Invert device and gently squeeze 3 full drops of pre-mixed blood into the sample well  (S) of the test cassette.

Read and record the results at 15 minutes by either of the following two options:

 

SEMI-QUANTITATIVE DETECTION

If two colored lines at Controle (C) and Test (T) regions are visible at 15 minutes, compare the color intensity of  van de lijn in het Test Line (T) with tow Reference Bands (sufficient or deficient) on the Color Chart provided in the kit.

color-chart

QUANTITATIVE DETECTION USING THE CUBE READER

Step 1: Place test cassette into adapter

Place the adapter on top of the test cassette to insert the test cassette into the adapter. Please make sure the orientation of insertion is correct as illustrated on the adapter.

cube-reader-ifu-02

Step 2: Place cube reader on the top of adapter

Place reader on top of the adapter/test cassette. For proper reader orientation and fit, place the slanted corner of the reader into the lower, left corner of the adapter’s reader setting space.

Stap 3: Turn-on the cube

Make sure the batteries enclosed in the cube reader are charged, or that the USB cable is connected correctly to a computer with power. Press the button on top of the cube reader briefly for less than 1 second. The cube reader will perform a self-test, ‘WAIT’ is displayed. After an audible signal, ‘ON’ is displayed.

Step 4: Upload Vitamin D test configuration and lot specific data from the RFID card to the cube reader

Press the button briefly, the display will show ‘RFID’. Put the lot specific RFID card onto the top side of the cube reader. Following an audible signal, ‘TEST’ is displayed.

cube-reader-ifu-04

Step 5: Start measurement 

Press the button briefly, the reader displays ‘RUN’ first, then Vitamin D concentration (VD) in ng/ml, with and audible signal.

Watch the Cube Reader video to see how the measurement is performed using the Cube Reader.