Vitamin D Total Assay

Siemens Healthineers Vitamin D Total assay provides consistent and clinically accurate vitamin D results with the highest throughput^† available, and is the only CDC-certified vitamin D assay with defined pediatric expected values*.

Established Reference Ranges for Pediatrics:

Provides easily adopted pediatric reference ranges (observed values)
Reduces lab resources needed to perform extensive reference range studies to establish intervals^§
Only 1% cross-reactivity to 3-epi, drastically reducing potential for over-recovery, thus eliminating risk of missed, deficiency

Proven CDC Certification (VDSCP):

Provides confidence in the accuracy and reliability of vitamin D testing
Allows for improvements in mean bias among VDSCP participants when compared to non-CDC certified assays
Gives clinicians confidence in 25(OH)vitamin D testing with traceability to the ID-LC-MS/MS reference measurement procedure (RMP)

lmproved Confidence with Proprietary Technology:

Provides low end sensitivity with patented AE technology
Prevents under-estimation of results with equimolar detection of Vitamin D₂ and D₃
Reduces lot-to-lot variability with proprietary monoclonal antibodies, which plays a key role when trending vitamin D levels

Maximized Throughput and Uptime:

Provides highest throughput^† of any dedicated IA platform in the market
Delivers uninterrupted workflow and lower operating costs with a long calibration frequency of 28 days*
Helps laboratories meet increased testing demands by consolidating vitamin D testing on fully automated, high-throughput systems

Pediatric Reference Ranges

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.^1,2

The pediatric serum samples used to establish the pediatric reference values included the following:^1,2

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:^1,2

	Specimen Type	Observed Value, Pediatric (12 months up to 21 years)
Median 25(0 H) 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:¹

Vitamin D Status	Range, Pediatric ng/ml (nmol/L)
Deficiency	< 15 ng/ ml (37.5 nmol/ L)
lnsufficiency	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 (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.3

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:⁴

Standardized at the manufacturer level against well-established reference values⁵
Certified on a yearly basis with quarterly performance assessments to monitor consistency^5,6

According to the CDC, there is an improvement in mean bias among VDSCP participants:⁴

Vitamin D tests that meet the following certification criteria are considered standardized:⁵

Assay Specifications

Atellica IM Vitamin D Total Assay

The Atellica IM Vitamin D Total assay provides consistent and clinically accurate vitamin D results with the highest throughput^† available and is the only CDC-certified vitamin D assay with defined pediatric expected values*.

Offers laboratories proven CDC-certified vitamin D assay, demonstrating quality and reliability with well-recognized AE technology
Gives clinicians confidence in 25(OH)vitamin D testing accuracy with traceability to the ID-LC-MS/MS reference measurement procedure (RMP)
Reduces potential erroneous results and retesting with equimolar detection of Vitamin D₂ and D₃, minimal interference to 3-epi, and no interference to biotin

	Atellica IM Vitamin D Total Assay¹
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

To learn more about the broad and growing menu of the Atellica Solution, link here

ADVIA Centaur Vitamin D Total Assay

Laboratories can meet increased testing demands by consolidating vitamin D testing on a fully automated, high-throughput immunoassay system.

Provides consistent and clinically accurate patient results with the equimolar total measurement of 25(OH)vitamin D₂ and D₃
Allows for Vitamin D to be combined with routine, stat, and specialty assays without compromising time – results are provided in 18 minutes with a throughput of 240 tests per hour
Reduces risk of confounding assessment with minimal cross-reactivity with 3-epi-25(OH)vitamin D₃(1.1%)

	ADVIA Centaur Vitamin D Total Assay²
Sample Type	Serum/Plasma (EDTA, lithium-heparin, sodium heparin)
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 Vitamin D Total Assay

Siemens Healthineers offers a LOCI® Vitamin D Total assay on the Dimension® EXL™ Integrated Chemistry Systems. This assay enables laboratories to provide highly accurate total 25(OH) vitamin D results (~100% D2 and D3) with a fast turnaround time. Vitamin D testing can now be consolidated with routine testing on a fully automated, high-throughput integrated chemistry system.

Offers laboratories a proven CDC-certified vitamin D assay, demonstrating quality and reliability
Gives clinicians confidence in 25(OH)vitamin D testing accuracy with traceability to the ID-LC-MS/MS reference measurement procedure (RMP)
Reduces potential erroneous results and retesting with equimolar detection of Vitamin D2 and D3
Minimal interference (<10% impact on results) from biotin up to 250 ng/mL
Minimal crossreactivity (<6%) from3-epi tested at 100 ng/mL

	Dimension EXL LOCI Vitamin D Total⁷
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

Services & Support Education & Training

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†Atellica IM System

*Atellica IM and ADVIA Centaur only

**Refer to CLSI EP28-A3c for recommendations on establishing and verifying reference ranges

***See competitor review

§As with all in vitro diagnostics assays, each laboratory should determine its own reference ranges for the diagnostics evaluation of patient results.

Atellica IM Analyzer Vitamin D Total (VitD) Assay IFU

ADVIA Centaur, ADVIA Centaur XP, ADVIA XPT Immunoassay Systems Vitamin D Total (VitD) Assay IFU

https://www.cdc.gov/labstandards/pdf/hs/CDC_Certified_Vitamin_D_Procedures.pdf

https://www.cdc.gov/labstandards/vdscp.html

https://www.cdc.gov/labstandards/vdscp_procedures.html

https://www.cdc.gov/labstandards/vdscp_participants.html

Dimension ExL LOCI Vitamin D Total (VitD) Assay IFU