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

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 quarterly, 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

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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

Vitamin D Total Assay flyer (pdf)

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

Improved Confidence with Proprietary Technology*:

Patented AE Technology allows for excellent low end sensitivity⁸
Equimolar detection of Vitamin D2 and D3 preventing underestimation of results^5-7
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 market^10-16
Uninterrupted workflow and lower operating costs with a long calibration frequency of 28 days*^4,5

Assay Specifications^5,6,7

	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 Type	Observed Value, Pediatric (12 months up to 21 years)
Median 25(OH)vitamin D	Serum	23.8 ng/mL (59.5 nmol/L)
Observed Range 2.5th to 97.5th Percentile	Serum	11.4–45.8 ng/mL (28.5–114.5 nmol/L)

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

Vitamin D Status	Range, Pediatric ng/mL (nmol/L)
Deficiency	< 15 ng/mL (37.5 nmol/L)
Insufficiency	15– < 20 ng/mL (37.5– < 50 nmol/L)
Sufficiency	20–100 ng/mL (50–250 nmol/L)

CDC Vitamin D Certification

The CDC has certified the ADVIA Centaur® Vitamin D Total assay, the Atellica® IM Vitamin D Total Assay, and the Dimension® EXL™ LOCI Vitamin D Total Assay. 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 quarterly basis with performance assessments to monitor consistency^2,3

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

Analytical performance criteria for routine tests used to measure total 25-hydroxyvitamin D

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.

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*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