Vitamin D Rapid Test

Product information

The Vitamin D Rapid Test is an immunochromatographic rapid test for the semi-quantitative detection of 25-hydroxyvitamin D (25 (OH) D) in human fingerstick Whole blood at a cut-off concentration of 30 ± 4ng/mL. This assay provides a preliminary diagnostic test result and can be used to screening for Vitamin D deficiency.

Advantages of Vitamin D test

• Easy to perform
• No complex sample collection needed
• Accurate test result

General information

Vitamin D refers to a group of fat-soluble secosteroids responsible for increasing intestinal absorption of calcium, iron, magnesium, phosphate and zinc. In humans, the most important compounds in this group are vitamin D3 and vitamin D2. Vitamin D3 is naturally produced in the human skin through the exposure to ultraviolet light and Vitamin D2 is mainly obtained from foods.

Vitamin D is transported to the liver where it is metabolized to 25-hydroxy Vitamin D. In medicine, a 25-hydroxy Vitamin D blood test is used to determine Vitamin D concentration in the body. The blood concentration of 25- hydroxy Vitamin D (including D2 and D3) is considered the best indicator of Vitamin D status. Vitamin D deficiency is now recognized as a global epidemic. Virtually every cell in our body has Receptors for Vitamin D, meaning that they all require “Sufficient” Level of Vitamin D for adequate functioning. The health risks associated with Vitamin D deficiency are far more severe than previously thought.

Vitamin deficiency has been linked to various serious diseases: Osteoporosis, Osteomalacia, Multiple Sclerosis, Cardiovascular Diseases, Pregnancy Complications, Diabetes, Depression, Strokes, Autoimmune Diseases, Flu, Different Cancers, Infectious Diseases, Alzheimer, Obesity and Higher Mortality etc. Therefore, now detecting (25-OH) Vitamin D level is considered as “Medically Necessary Screening Test”, and maintaining sufficient levels not just to improve bone health, but to improve overall health and well-being.

The Vitamin D test is an immunoassay based on the principle of competitive binding. During testing, the mixture migrates upward on the membrane chromatographically by capillary action. The membrane is pre-coated with 25 (OH) D antigens on the test line region of the strip. During testing, 25 (OH) D present in the specimen will compete with 25 (OH) D on the test line for limited amount of anti-25 OH Vitamin D antibodies in the conjugate.

The higher concentration of 25 (OH) D in the specimen, the lighter would be the T line. The result will be read according to Color card provided with the kit. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Specimen Collection 

The Vitamin D Rapid Test Cassette can be performed using whole blood (from fingerstick).

To collect Fingerstick Whole Blood specimens:

1. Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.
2. Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.
3. Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
4. Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
5. Add the Fingerstick Whole Blood specimen to the test by using a capillary dropper.
6. Touch the end of the capillary dropper to the blood, do not squeeze the bulb of the dropper, the blood migrates into the dropper through the capillarity to the line indicated on the dropper. Avoid air bubbles.
7. Squeeze the bulb to dispense the whole blood to the specimen area of the test Cassette.
8. Testing should be performed immediately after the fingerstick Whole Blood have been collected.

Test procedure

1. Allow the test, specimen, buffer and/or controls to reach room temperature (15- 30°C) prior to testing
2. Remove the test cassette from the sealed pouch and use it as soon as possible.
3. Place the cassette on a clean and level surface.

*To use a Capillary droppers: Fill the capillary tube and transfer approximately 20mL of fingerstick whole blood specimen to the specimen area of test cassette, then add 2 drops of buffer and start the timer. See illustration below.

4. Wait for the colored line(s) to appear. Read results at 10 minutes by comparing the T line intensity with provided color card. Do not interpret the result after 20 minutes.

*Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.

Interpretation of the results

Deficient: Two distinct colored lines appear. One is in the control region (C) and another should be in the test region (T). The line intensity in the test region (T) is equal to or darker than 10 ng/mL line depicted on color card provided with the kit.

Insufficient: Two colored lines appear. One is in the control region (C) and another should be in the test region (T). The line intensity in the test region (T) is darker than the 30 ng/mL line depicted on the color card provided with the kit and lighter than 10 ng/mL line depicted on Color card provided with the kit.

Sufficient: Two colored lines appear, one line should be always in the control region (C) and faint colored line appears in the test region (T). The line intensity in region (T) is darker than the 100 ng/mL line depicted on the Color card and lighter than 30 ng/mL line depicted on color card.

*Note: Always compare the T line intensity with “Vitamin D Color card” and interpret results accordingly.

Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local supplier.