Vitamin D Rapid Test Kit 

Vitamin D Rapid Test Kit is a rapid and convenient immunochromatographic assay for the semi quantitative detection of 25-hydroxy vitamin D (25-OH
vitamin D) in human Whole Blood. The device is designed for over-the- counter use as well as professional use. This assay provides only a preliminary result.
Clinical consideration and professional judgment should be applied to Vitamin D deficiency test results. Particularly in evaluating a preliminary positive result,
a more specific chemical method is advised

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, Osteoma Acia, Multiple Sclerosis, Cardiovascular Diseases, Pregnancy
Complications, Diabetes, Depression, Strokes, Autoimmune Diseases, Flu, Different Cancers, Infectious Diseases, Alzheimer, Obesity and Higher Mortality
etc. Therefore, the detection of 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

SUMMARY AND PRINCIPLE OF THE ASSAY
Vitamin D is a group of fat-soluble ketosteroids responsible for increasing intestinal absorption of calcium, magnesium, zinc, iron etc. The most essential
compounds in this group are Vitamin D2 and D3, D2 is mainly Obtained from food, and D3 is naturally produced in human skin through the exposure to
ultraviolet light. Vitamin D is transported to the liver where it is metabolized to 25 - hydroxy Vitamin D (25-OH vitamin D). In clinical, a 25-OH vitamin D whole
blood test is used to determine Vitamin D concentration in the body. The whole blood concentration of 25-OH vitamin D (including D2 and D3) is considered
the best indicator of Vitamin D status:

Deficiency: < 12 ng/ml (30 nM)
Insufficient: 12-20 ng/ml (30-50 nM)
Insufficient: 20-50 ng/ml (50-125 nM) Insufficient: > 50 ng/ml (> 125 nM)

Deficient (< 12 ng/ml):
One red band appears in the control region (C). No or a faint red band appears at the test region (T). The red band intensity in the test region (T) is weaker
than the 12 -20 ng/mL color band depicted on the reference card. It is recommended to consult a physician for a deficient result.
Insufficient (12-20 ng/ml):
Two red bands appear. One is in the control region (C), another one is in the test region (T). The red band intensity in the test region (T) is weaker than the
20-50 ng/mL color band depicted on the reference card
Sufficient (20-50 ng/ml):
Two red bands appear. One is in the control region (C), another one is in the test region (T). The red band intensity in the test region (T) is darker than
12-20 ng/mL color band and lighter than > 50 ng/mL color band depicted on the reference card.
Excess (> 50 ng/ml):
Two red bonds appear. One is in the control region (C), another one is in the test region (T). The red band intensity in the test region (T) is darker than the
20-50 ng/mL color band depicted on the reference card.
Invalid:
No visible band appears at the control region (C). Repeat with a new test kit. If the test still fails, please contact the distributor with the lot number

For in vitro diagnostic use only.
· Do not reuse.
· Do not use if the pouch seal or its packaging is compromised.
· Do not use after the expiration date shown on the pouch.
· Do not mix and interchange different specimens.
· Wear protective clothing such as laboratory coats, disposable gloves and eye protection while
handling potentially infectious materials or performing the assay.
· Wash hands thoroughly after finishing the tests.
· Do not eat, drink, or smoke in the area where the specimens or kits are being handled.
· Clean up spills thoroughly with appropriate disinfectants.
· Handle all specimens as if they contain infectious agents. Observe established precautions
against microbiological hazards throughout testing procedures.
· Dispose of all specimens and used devices in a proper bio-hazard container. The handling
and disposal of hazardous materials should follow local, national or regional regulations.
· Keep out of children's reach.