Home Health Vitamin D Test - Accurate Blood Testing Kit

What is Vitamin D Deficiency?

Vitamin D is essential for healthy bones. Some people don’t have enough vitamin D – called vitamin D deficiency.

Why do I need this test?

Between October and March, the sunlight in Britain is not strong enough to make enough vitamin D, and up to a quarter of the population has low levels of it in their blood.

Vitamin D deficiency can put people at risk of Rickets or Osteomalacia and some research suggests that not getting enough of it may also be linked to Heart conditions, Diabetes, Asthma and Cognitive impairment in older adults.

Vitamin D deficiency at-risk groups:

The Chief Medical Officers of the UK say these groups are at particular risk of vitamin D deficiency:

• Pregnant and breastfeeding women, especially teenagers and young women.
• Infants and children under 5 years of age.
• People 65 and over.
• People who have little or no exposure to the sun. This includes covering-up for cultural reasons, people who are housebound or who stay indoors for long periods of time.

Limitations

• The Vitamin D Rapid Test Cassette provides only a semi-quantitative analytical result. A secondary analytical method must be used to obtain a confirmed result.
• It is possible that technical or procedural errors, as well as other interfering substances in the whole blood specimen may cause erroneous results.
• The Cut-off for the test is 30ng/mL with a deviation range of ±4ng/mL.

• As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

• Other clinically available tests are required if questionable results are obtained.

Additional information:

How does the Vitamin D test work?

25-hydroxy Vitamin D is the main storage form of vitamin D in the body. Therefore, the overall status of vitamin D can be determined by detecting the content of 25-hydroxy Vitamin D. 25-hydroxy Vitamin D levels less than 30ng/mL, indicates Vitamin D Deficiency or Insufficiency. Vitamin D supplements can be recommended in these cases.

When should the test be used?

The clinical application of 25-hydroxy Vitamin D is mainly for diagnosis, treatment and monitoring of rickets (children), osteomalacia, postmenopausal osteoporosis and renal osteopathy. Vitamin D deficiency is also associated with many other diseases, including cancer, cardiovascular disease, autoimmune diseases, diabetes and depression. Monitor your vitamin D levels to determine whether to take vitamin D supplements. The Vitamin D Rapid Test can be used any time of the day.

Can the result be incorrect?

The results are accurate as far as the instructions are carefully respected. Nevertheless, the result can be incorrect if the Vitamin D Rapid Test cassette gets wet before performing the test, or if the quantity of blood dispensed in the sample well is not sufficient, or if the number of buffer drops are less than 2 or more than 3. The capillary dropper provided in the box enables you to ensure the collected blood volume is correct. Due to immunological principles involved, there is also the possibility of false results in rare cases. A consultation with a doctor is always recommended for such tests based on immunological principles.

How to interpret the test if the colour and the intensity of the lines are different?

Please refer to the illustration and compare the T line intensity with the “Vitamin D Colour card” provided with the kit.

If I read the result after 20 minutes, will the result be reliable?

No. The result should be read 10 minutes after adding the buffer. The result is unreliable after 20 minutes.

What do I have to do if the result is deficient or insufficient?

If the result is sufficient, it means that the Vitamin D level is higher than or equal to 30ng/mL and is within the normal range.

Can my Vitamin D levels be too high?

A case of Vitamin D toxicity (hypercalcemia) is rare, but cannot be excluded based on the test results. If symptoms persist, it is recommended to consult a physician.

Directions:

1. Wash your hands with soap and rinse with clear warm water. 2. Bring the pouch to room temperature before opening it. Open the pouch, remove the test cassette and place it on a clean and level surface. Run the testing within one hour and best results will be obtained if the test is performed immediately after opening the foil pouch. Remove the dropper, buffer vial, lancets and Alcohol pad and place them close to the test cassette. 3. Carefully pull off and dispose of the clear plastic cap of the lancet. The lancet is a single use lancet so make sure you do not fire the lancet prematurely. 4. Use the provided Alcohol pad to clean the fingertip of the middle or ring finger as the puncture site. Allow to air dry. 5. Press the lancet (on the side from where the cap was removed) firmly against the fingertip. The tip retracts automatically and safely after use. 6. Keeping the hand down, massage the finger that was pricked to obtain a blood drop. 7. Without squeezing the capillary dropper bulb, gently put it in contact with the edge of the blood drop. The blood should automatically be drawn up the dropper by capillary action. You should fill the dropper up to the black line. You may continue to massage your finger to obtain more blood if the line is not reached. As far as possible, try to avoid air bubbles. 8. Transfer the collected blood into the sample well (S) of the cassette, by squeezing the dropper bulb. 9. Wait for the blood to be totally dispensed in the well. Unscrew the cap of the buffer bottle and add 2 drops of buffer into the Buffer well (B) of the cassette and start a timer. 10. Wait for the coloured line(s) to appear. Read results at 10 minutes. Compare the intensity of the Test Line (T) with the provided "Vitamin D Colour Card" to determine the Vitamin D level in your blood. Results obtained after 10 minutes may be inaccurate. .

Advisory information:

Please read all the information in this package insert before performing the test.

• For self-testing in vitro diagnostic use only.

• Do not eat, drink or smoke in the area where the specimens or kits are handled.

• Store in a dry place at 2-30°C (36-86°F), avoiding areas of excess moisture. If the foil packaging is damaged or has been opened, please do not use.

• This test kit is intended to be used as a preliminary test only and repeatedly abnormal results should be discussed with a doctor or medical professional.

• Follow the indicated time strictly.

• Use the test only once. Do not dismantle and touch the test window of the test cassette.

• The kit must not be frozen or used after the expiration date printed on the package.

• Keep out of the reach of children.

• The used test should be discarded according to local regulations.

STORAGE AND STABILITY

Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the

sealed pouch. The test must remain in the sealed pouch until use.DO NOT FREEZE. Do not use after the expiration date.

Remember to:

Although we make every effort to ensure our product information is up to date on our website, please always read labels, warnings, and directions provided with the product before using or consuming the product.

Kit Includes:

Materials Provided:

1. Test Cassette

2. Buffer

3. 2 x Lancets

4. Alcohol Pad

5. Capillary Dropper

6. Package Insert

7. Colour Card

Materials Required But Not Provided : Timer