The CiTEST Vitamin D Rapid Test is 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 screen for Vitamin D deficiency.
For self-testing in vitro diagnostic use only.
About Vitamin D
Vitamin D refers to a group of fat-soluble seco steroids 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.
About Vitamin D Deficiency
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.
Vitamin D Test – Box Contents
1 – Test Cassette
1 – Buffer
2 – Safety Lancet
1 – Alcohol Pad
1 – Capillary Dropper
1 – Result Comparison Card
1 – Instructional Insert
How to Use
Instructions: View a PDF of the package insert.
Intended Use
The Vitamin D Rapid Test Cassette is a rapid chromatographic immunoassay for the semi-quantitative detection of 25-hydroxyvitamin D (25 (OH) D) in human fingerstick Whole blood. This assay provides a preliminary diagnostic test result and can be used to screening for Vitamin D deficiency.
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 the 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.
Precautions
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 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.
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.
- 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.
By purchasing this product, you agree to follow the manufacturer’s intended use and the sale conditions of this website.
Frequently Asked Questions
How does the Vitamin D test work?
In medicine, a 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 level less than 30 ng/mL in case of a positive result, 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 test performing 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 allows making sure the collected blood volume is correct. Besides, due to immunological principles involved, there exist the chances of false results in rare cases. A consultation with the doctor is always recommended for such tests based on immunological principles.
How to interpret the test if the color and the intensity of the lines are different?
Please refer to the illustration and compare the T line intensity with “Vitamin D Color card” provided with the kit.
If I read the result after 20 minutes, will the result be reliable?
No. The result should be read at 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 deficient or insufficient, it means that the Vitamin D level in blood is less than 30 ng/mL and that you should consult a physician to show the test result. The physician will decide whether additional analysis should be performed.
What do I have to do if the result is sufficient?
If the result is sufficient, it means that the Vitamin D level is higher than or equal to 30 ng/mL and is within the normal range. A case of Vitamin D toxicity (hypercalcemia), though rare, but cannot be excluded based on such test results. However, if the symptoms persist, it is recommended to consult a physician.
Debra Bates (verified customer) –
Knowing your Vitamin D levels is crucial, especially in places with limited sunlight. This test is a blessing!
Anne Dennis (verified customer) –
Rapid Test & Trace has nailed it with the CiTEST Vitamin D Test. No more expensive clinic visits for me. This does the job perfectly!
Charles Boyle (verified customer) –
Recently bought the CiTEST Vitamin D Test from Rapid Test & Trace. It was user-friendly and provided accurate results. Highly recommend!
Thomas Shaffer (verified customer) –
I was concerned about my vitamin D levels. Thanks to Rapid Test & Trace, I now have peace of mind!
Stephanie Parker (verified customer) –
The Vitamin D Test from Rapid Test & Trace was quick and easy to use. Received my results promptly. Highly recommend!