Vitamin D Total Assay
Siemens Healthineers Vitamin D Total Assay is the only CDC certified method with defined pediatric expected values* and the highest throughput***.

Vitamin D Total Assay
 
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Design matters. Utilize reference ranges that are established for children and easily adopted. Only 1.1% cross-reactivity to 3-epi, reducing the potential for over-recovery and the risk of missed deficiency. Equimolar detection of Vitamin D2 and D3, lowering the risk of underestimation of results. VDSCP certification, renewed yearly, for full confidence in accuracy and reliability. The Vitamin D Total Assay from Siemens Healthineers allows labs to consolidate Vitamin D testing with other routine tests on fully-automated, high-throughput systems. The assay is available on the Atellica® Solution, Dimension® EXL™ Integrated Chemistry System, and ADVIA Centaur® Immunoassay System.1-16

Established for Pediatrics*:

  • Easily adopted reference ranges**
  • Reduce lab costs and resources associated with establishing ranges**
  • Only 1% cross-reactivity to 3-epi, drastically reducing potential for over-recovery, thus eliminating risk of missed deficiency 5-7

CDC Certification (VDSCP):

  • There is an improvement in mean bias among VDSCP participants when compared to non-CDC certified assays1
  • All 3 assays (ADVIA Centaur, Atellica IM and Dimension EXL) are currently CDC certified by the VDSCP4
  • CDC certification (VDSCP) checks accuracy and reliability of vitamin D testing on a quarterly basis, with a required yearly
  • renewal2,3

Improved Confidence with Proprietary Technology*:

  • Patented AE Technology allows for excellent low end sensitivity8
  • Equimolar detection of Vitamin D2 and D3 preventing underestimation of results5-7
  • Proprietary monoclonal antibodies minimize lot to lot variability, playing a key role when trending patient vitamin D levels9

Maximized Throughput and Uptime:

  • Highest throughput of any Immunoassay platform on the market10-16
  • Uninterrupted workflow and lower operating costs with a long calibration frequency of 28 days*4,5

Assay Specifications5,6,7


Atellica IM Vitamin D Total Assay
Sample Type
Serum
Sample Volume
20 uL
Assay Range
4.20 – 150.0 ng/mL [10.50–375.00 nmol/L]
Limit of Quantitation
2.73 ng/mL [6.83 nmol/L]
Calibration Interval
28 days
Onboard Stability
28 days
Time to First Result
14 minutes

Advia Centaur Vitamin D Total Assay
Sample Type
Serum
Sample Volume
20 uL
Assay Range
4.20 – 150.0 ng/mL [10.50–375.00 nmol/L]
Limit of Quantitation
4.2 ng/mL [10.50 nmol/L]
Calibration Interval
28 days
Onboard Stability
28 days
Time to First Result
18 minutes

Dimension EXL LOCI Vitamin D Total Assay
Sample Type
Serum, Lithium Heparin Plasma, EDTA Plasma
Sample Volume
8 uL
Assay Range
5.0 – 150.0 ng/mL [12.50–375.00 nmol/L]
Limit of Quantitation
5.0 ng/mL [12.50 nmol/L]
Calibration Interval
7 days
Onboard Stability
30 days
Time to First Result
31 minutes

Reference Ranges for Pediatrics

With defined pediatric reference ranges for the Atellica IM and ADVIA Centaur Vitamin D Total assays, ranges can be easily adopted with a simple in-lab validation** and lab resources associated with establishing ranges can be used for more productive work.

Atellica IM and ADVIA Centaur Vitamin D Total reference values were established in accordance with CLSI guideline EP28-A3c using adult and pediatric serum samples.5,6 

The pediatric serum samples used to establish the pediatric reference values included the following:5,6

  • A population consisting of 237 apparently healthy male and female subjects of light and dark skin types with:

               • 32 subjects between the ages of 1-3 years

               • 114 subjects from 3-12 years

               • 91 subjects from 13-21 years

  • Samples from different seasons
  • Samples from different geographical regions of the United States
  • Samples with normal values for PTH and TSH

Based on the 95% confidence interval, the following pediatric values were obtained:5,6

 Specimen TypeObserved Value, Pediatric
(12 months up to 21 years)
Median 25(OH)vitamin DSerum23.8 ng/mL
(59.5 nmol/L)
Observed Range 2.5th to
97.5th Percentile
Serum11.4–45.8 ng/mL
(28.5–114.5 nmol/L)

Expected Pediatric Values based on literature reviewed by Siemens Healthineers:5,6

Vitamin D StatusRange, Pediatric
ng/mL (nmol/L)
Deficiency< 15 ng/mL (37.5 nmol/L)
Insufficiency15– < 20 ng/mL (37.5– < 50 nmol/L)
Sufficiency20–100 ng/mL (50–250 nmol/L)

CDC Vitamin D Certification

The CDC has certified the ADVIA Centaur® Vitamin D Total assay (6 years), the Atellica® IM Vitamin D Total Assay (1 year), and the Dimension® EXL™ LOCI Vitamin D Total Assay (2 years). A complete list of certified methods is posted and continually updated on the CDC website.4

The goal of the Vitamin D Standardization-Certification Program (VDSCP) is to ensure vitamin D testing is accurate and reliable. In a unique, two-phased process, vitamin D tests are:1

  • Standardized at the manufacturer level against well-established reference values3
  • Certified on a yearly basis with quarterly performance assessments to monitor consistency2,3

According to the CDC, there is an improvement in mean bias among VDSCP participants:1

Vitamin D tests that meet the following certification criteria are considered standardized:3

If you are interested in adding the Vitamin D Total Assay to your Atellica Solution, Dimension EXL, or ADVIA Centaur system menu, please contact your local customer representative or the Inside Sales Department at (800) 242-3233, option 3.

*Atellica IM and ADVIA Centaur only
**Refer to CLSI EP28-A3c for recommendations on establishing and verifying reference ranges
*** See competitor review

1. https://www.cdc.gov/labstandards/vdscp.html
2. https://www.cdc.gov/labstandards/vdscp_participants.html
3. https://www.cdc.gov/labstandards/vdscp_procedures.html
4. https://www.cdc.gov/labstandards/pdf/hs/CDC_Certified_Vitamin_D_Procedures.pdf
5. Atellica IM Analyzer Vitamin D Total (VitD) Assay IFU
6. ADVIA Centaur, ADVIA Centaur XP, ADVIA XPT Immunoassay Systems Vitamin D Total (VitD) Assay IFU
7. Dimension ExL LOCI Vitamin D Total (VitD) Assay IFU
8. AE Technology_160402-GC1_AE_Smart_Card_FINAL.pdf

9. 131861 DiaSorin Vitamin D SMART chart.pdf
10. https://www.siemens-healthineers.com/en-us/integrated-chemistry/systems/atellica-solution-analyzers/technical-details
11. https://diagnostics.roche.com/us/en/products/systems/cobas_-8000-modular-analyzer-series.html#productSpecs
12. https://www.beckmancoulter.com/en/products/immunoassay
13. https://www.orthoclinicaldiagnostics.com/en-us/home/products/vitros-3600
14. https://www.orthoclinicaldiagnostics.com/en-us/home/products/vitros-eciq
15. https://www.corelaboratory.abbott/us/en/offerings/brands/architect/architect-i4000SR
16. https://www.corelaboratory.abbott/sal/specSheet/ADD-00059833_Alinity_Specifications.pdf