| Code: | AC-57SF1 |
|---|---|
| Certification: |
CE Marked |
| Clinical Area: | Calcium Metabolism |
| Type: | Manual |
| Format: | EIA |
| RUO/IVD: | IVD |
| Number of Tests: | 96 (40 samples in duplicate) |
| Sample Type: | Serum. EDTA and Heparin Plasma |
| Sample Volume: | 25 μL |
| Assay Range: | 0 - 104 ng/mL (0 to 260 nmol/L) |
Unique Features
- Assure patient results through standardisation to the VDSP ID-LC-MS/MS Reference Method Procedure (RMP)
- Actionable clinical assessment of vitamin D status provided by measurement of total 25(OH) vitamin D with co-specificity of 25(OH) vitamin D3 and 25(OH) vitamin D2
- Convenient reagent handling with excellent stability combined with ready to use calibrators and controls
- Assures accuracy of patient results through standardisation to the VDSP ID-LC-MS/MS Reference Method Procedure (RMP)
- Reliable test for monitoring vitamin D therapy, regardless of supplementation form
- Confidence in patient results
The 25-Hydroxy Vitamin DS EIA Assay is intended for the quantitative determination of 25-hydroxyvitamin D [25(OH)D] and other hydroxylated metabolites in human serum and plasma.
Vitamin D is a fat-soluble steroid pro-hormone. Of the two major forms Ergocalciferol (D2) and Cholecalciferol (D3), only vitamin D3 is synthesised by the body. Main vitamin D sources are: UV exposure from sun which leads to Cholecalciferol production in the upper layers of the skin, foods such as fish, shellfish, mushrooms, vitamin D fortified foods (e.g. milk, juice) and supplements. Approximately 10 – 20 % of vitamin D is supplied through nutritional intake. Vitamin D is stored in adipose tissue and enters the circulation bound to vitamin D binding protein (VDBP) and albumin.In the liver, vitamin D is hydroxylated to give 25(OH)D which also circulates as a complex with VDBP. A small proportion of the 25(OH)D is further hydroxylated in the kidney, under direct regulation by parathyroid hormone and ionised calcium levels, to form the biologically-active calcitropic hormone 1,25-dihydroxyvitamin D [1,25(OH)2D]. Vitamin D plays a major role in the calcium and phosphorus homeostasis. Vitamin D deficiency is a cause of hyperparathyroidism and diseases related to impaired bone metabolism (e.g. rickets, osteoporosis, and osteomalacia).
Download: CDC Certified Vitamin D Procedures
Sempos C. et al. Vitamin D status as an international issue: National surveys and the problem of standardization. Scand J Clin Lab Invest Suppl. 2012 Apr; 72(Suppl 243):32-40.
Holick, MF., et al. “Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline.” The Journal of Clinical Endocrinology & Metabolism 96.7 (2011): 1911-1930.
