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Vitamin D Total Assay

Vitamin D Total Assay
 
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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 TypeObserved Value, Pediatric
(12 months up to 21 years)
Median 25(0 H) vitamin DSerum23.8 ng/ml
(59.5 nmol/L)
Observed Range 2.5th to 97.5th PercentileSerum11.4-45.8 ng/mL
(28.5-114.5 nmol/L)


Expected Pediatric Values based on literature reviewed by Siemens Healthineers:1

Vitamin D StatusRange, Pediatric
ng/ml (nmol/L)
Deficiency< 15 ng/ ml (37.5 nmol/ L)
lnsufficiency15- < 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.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 consistency5,6
VDSCP MEAN BIAS GRAPH

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

VDSCP MAX BIAS TABLE

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 TypeSerum
Sample Volume20 uL
Assay Range4.20 - 150.0 ng/mL [10.50-375.00 nmol/L]
Limit of Quantitation2.73 ng/mL [6.83 nmol/L]
Calibration Interval28 days
Onboard Stability28 days
Time to First Result14 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 TypeSerum/Plasma (EDTA, lithium-heparin, sodium heparin)
Sample Volume20 uL
Assay Range4.20 - 150.0 ng/mL [10.50-375.00 nmol/L]
Limit of Quantitation4.2 ng/mL [10.50 nmol/ L]
Calibration Interval28 days
Onboard Stability28 days
Time to First Result18 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 TypeSerum, Lithium Heparin Plasma, EDTA Plasma
Sample Volume8 uL
Assay Range5.0 - 150.0 ng/mL [12.50-375.00 nmol/L]
Limit of Quantitation5.0 ng/mL [12.50 nmol/ L]
Calibration Interval7 days
Onboard Stability30 days
Time to First Result31 minutes

†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.

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