Elecsys® Vitamin D total
Reliable results guiding decisions on vitamin D supplementation
- One billion people worldwide are estimated to suffer from vitamin D deficiency or insufficiency - mainly due to the lack of sun exposure with modern lifestyles
- Vitamin D has a proven impact on bone mineral density - supplementation can significantly reduce the risk of falls and fractures as well as improve muscle strength, balance and mobility
- Growing scientific evidence indicates that low 25-OH vitamin D levels are associated with increased risk of cardiovascular diseases, infections, autoimmune diseases and different forms of cancer
- 25-OH vitamin D levels should be measured in high risk populations (e.g. patients with or at risk for osteoporosis, patients with rickets/osteomalacia, chronic kidney disease, malabsorption syndrome) to identify the need for supplementation
- Due to the large interindividual variability in vitamin D response, testing should be repeated upon supplementation to ensure that optimal levels are reached
- Effective monitoring has the potential to improve dose individualization and encourage compliance with therapy
- Elecsys® Vitamin D total assay enables better clinical decisions on vitamin D supplementation by providing reliable results based on robust technical performance
- The assay traceability to recognized reference methods and materials ensures high accuracy
- The excellent precision and lot-to-lot consistency ensure effective monitoring
|Assay time||27 min|
|Sample material||serum and plasma|
|Sample volume||15 μL
|Functional sensitivity||4.01 ng/mL (10.0 nmol/L) (CV 18.5 %)|
|Measuring range||3.00 – 70.0 ng/mL (7.50 – 175 nmol/L)
||<15 ng/mL: SD ≤1.7 ng/mL, >15 ng/mL: ≤11.5 %
|Standardization||LC-MS/MS standardized with NIST standard reference material|
|Analytical specificity||Vitamin D3 (25-OH): 100 %; Vitamin D2 (25-OH): 92 %|
Proven performance for assessing vitamin D sufficiency
Confidence in results
- Standardized against liquid chromatography tandem mass spectrometry (LC-MS/MS) and traceable to NIST international standards to ensure confidence in accurate patient results
- Excellent functional sensitivity to allow reliable identification of severely deficient cases
Consistent and precise
- High lot-to-lot consistency and precision to ensure optimal monitoring of vitamin D supplementation
- Provides one consistent result across all systems and sample types
- Consolidation of the complete bone marker panel (Vitamin D total, PTH, β-CrossLaps, P1NP and Osteocalcin) testing on one fully automated platform to maximize efficiency
Elecsys Vitamin D assay shows a robust correlation to LC-MS/MS
Evaluation of the Elecsys Vitamin D total assay demonstrates fitness for medical use:
Wielders, J.P.M., Eberl, H., Pongratz, S., Vogl, C. Vitamin D Workshop 2013.
The Elecsys Vitamin D Total assay fulfills the demands of imprecision (“total error”) <10% and bias <5% (compared to the reference LC-MS/MS) and demonstrates good overall performance. This makes it fit for use in daily routine vitamin D testing.
Accuracy of 6 routine 25-hydroxyvitamin D assays: influence of vitamin D binding protein concentration.
Heijboer, A.C., Blankenstein, M.A., Kema I.P., Buijs, M.M. Clin Chem 2012;58(3):543-8
Only the fully automated Roche assay and the RIA did not show VDBP concentration-dependent differences compared to LC-MS/MS. Measurements performed with the other fully automated assays suffer from inaccuracies that are VDBP concentration dependent. Therefore, when interpreting results of 25(OH)D measurements, careful consideration of the measurement method is necessary.
The new Roche Vitamin D Total assay: fit for its purpose?
Emmen, J.M.A., Wielders, J.P.M., Boer, A.K., van den Ouweland J.M., Vader H.L. Clin Chem Lab Med 2012;50(11):1969-72
The new Elecsys Vitamin D Total immunoassay showed good overall analytical performance with low imprecision and reasonable to good agreement to other established methods for 25(OH)D analysis. Its fully automated design enables high throughput to cope with rising clinical demand for 25(OH)D measurements.