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 Proprielary 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
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
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
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
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%)
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.
- Provides excellent sensitivity for more-accurate differential diagnosis of vitamin D insufficiencies and improved patient care.
- Offers good reagent and calibration stability for improved operational and labor efficiency with less hands-on time.
- Allows workload consolidation of routine and specialized tests for increased productivity.
†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
7. Dimension ExL LOCI Vitamin D Total (VitD) Assay IFU