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Vitamin D, 25-OH, Total Level

Principle

Vitamin D is a fat-soluble hormone essential for the regulation of calcium and phosphorus homeostasis and the maintenance of bone health. Increasing evidence also supports a role for vitamin D in cardiovascular disease, cancer, and autoimmune disorders.

Vitamin D is obtained through cutaneous synthesis following sun exposure (vitamin D₃), dietary intake (vitamin D₂ or D₃), and supplementation. It is metabolized in the liver to 25-hydroxyvitamin D [25-OH vitamin D], the major circulating form and precursor to the biologically active metabolite, 1,25-dihydroxyvitamin D. Due to its stability and relatively long half-life of approximately three weeks, serum 25-OH vitamin D measurement is the preferred indicator of vitamin D status.

The Vitamin D, 25-OH, Total assay measures both 25-OH vitamin D₂ and 25-OH vitamin D₃ equally. This competitive immunoassay is performed using the VITROS 25-OH Vitamin D Total Reagent Pack on the VITROS ECi Immunodiagnostic System. Vitamin D, 25-OH in the patient sample competes with horseradish peroxidase (HRP)–labeled vitamin D for binding to monoclonal anti-vitamin D antibodies. The emitted chemiluminescent signal is inversely proportional to the concentration of vitamin D, 25-OH present in the sample.

Specimen Requirements

Specimen

Serum (red-top tube with no additive or serum separator tube, SST).

Collection

Separate serum from clot as soon as possible to prevent hemolysis.

Processing

Separate serum from clot as soon as possible to prevent hemolysis.

Storage and Transport

Store/transport at 15–30°C for ≤72 hours; 2–8°C for ≤7 days; freeze at ≤ –20°C if delayed (stable up to 1 year frozen). Avoid repeated freeze–thaw cycles.

Unacceptable Specimens

Hemolyzed or lipemic specimens.

Method

Enhanced chemiluminescence, competitive immunoassay

Normal Range

Endocrine Society Clinical Practice Guidelines

Vitamin D Status 25-OH Vitamin D (ng/mL)
Deficient < 20
Insufficient 20 – < 30
Sufficient 30 – 100
Upper Safety Limit > 100

Turnaround Time

3 days

References

  • Holick MF. Vitamin D deficiency. New England Journal of Medicine. 2007;357:266–281.
  • VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Pack. Publication No. GEM1361_US_EN.
  • Holick MF, et al. Evaluation, treatment, and prevention of vitamin D deficiency: An Endocrine Society Clinical Practice Guideline. Journal of Clinical Endocrinology & Metabolism. 2011;96(7).

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