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Ensayo ADVIA Centaur de Vitamina D Total

Ensayo de Vitamina D Total ADVIA Centaur

Siemens Healthcare Diagnostics ofrece un ensayo total de vitamina D (~100% D2 y D3) completamente equimolar y automatizado, que emplea un monoclonal patentado con un porcentaje mínimo de reactividad cruzada de 1.1 con 3-epi-25(OH)vitamina D3 alineado con el Procedimiento de Medición de Referencia (RMP)1,2, ID-LC/MS/MS de 25(OH)vitamina D, el procedimiento de referencia para el Programa de Estandarización de Vitamina D (VDSP). Los laboratorios pueden cumplir con las crecientes demandas de las pruebas mediante la consolidación de las pruebas de vitamina D con un sistema de inmunoensayo de alto rendimiento completamente automatizado.

Ventajas

  • Confianza en los resultados mediante la alineación con el RMP1,2de 25(OH) vitamina D
  • Procedimiento certificado del Programa de Certificación y Estandarización de la Vitamina D (VDSCP) del CDC†
  • Resultados de pacientes consistentes y clínicamente exactos con la medición total equimolar de 25(OH)vitamina D2 y D3
  • La vitamina D se puede combinar con ensayos de rutina, estadísticos y de especialidad sin comprometer el tiempo; los resultados se proporcionan en 18 minutos con un rendimiento de 240 pruebas por hora
  • El anticuerpo monoclonal patentado proporciona consistencia de lote a lote
  • Reducción del riesgo de confusión en la evaluación con una reactividad cruzada mínima con 3-epi-25(OH) vitamina D3(1.1%)
  • Un amplio rango de ensayo dinámico (4.2-150 ng/mL) y la dilución integrada se ajustan a la variedad de resultados de los pacientes con una intervención mínima.

Características

  • Medición total de 25(OH)vitamina D2 y D3
  • Buena precisión – 4.2% - 11.9% CV
  • Rastreable al RMP de ID-LC/MS/MS de 25(OH)vitamina D
  • Resultados en tan sólo 18 minutos (ADVIA Centaur® XP) 
     

 

Vitamin D Assay Specifications

Assay Specifications

 

ADVIA Centaur Vitamin D Total Assay

Product Code

10699201 (100 tests), 10699533 (500 tests)

Sample Type

Serum / Plasma (EDTA, lithium-heparin, sodium heparin)

Sample Volume

20 µL

Assay Range

4.2 - 150 ng/mL

Limit of Quantitation

4.2 ng/mL

Calibration Interval

28 days

Onboard Stability

28 days

Vitamin D Standardization

Why Are Standardized Reference Materials Important?

Standardization of reference materials for in vitro diagnostic tests helps to harmonize results across test manufacturers and methods to improve the diagnosis, treatment, and prevention of disease. Reference standards serve as an anchor that can provide comparability across time and methods. Developing reference standards for assays is not a universal or easy procedure; success of any international reference material depends on that material being commutable across all manufacturers and methods.

Impact of the Lack of Standardization for Vitamin D

Without an internationally recognized, commutable vitamin D reference material, biases in slopes across methods and manufacturers can be observed. Scatter is apparent in assay comparisons between manufacturers as well as between laboratory-developed LC/MS/MS assays; this scatter may be due to differences in the way the different manufacturers’ systems measure vitamin D, varying vitamin D releasing processes, and heterophilic interferences.
Vitamin D standardization is necessary to create the anchor vitamin D values need, and it is important that laboratories and clinicians know how their vitamin D assay is standardized.

The Vitamin D Standardization Program (VDSP)

VDSP is an initiative of the NIH Office of Dietary Supplements (NIH ODS) and a collaboration with the National Institute of Standards and Technology (NIST), the CDC, and Ghent University.

  • VDSP, under the coordination of Christopher Sempos, PhD, NIH ODS, aims to standardize 25(OH)vitamin D measurement across methods and manufacturers.
  • The NIST Reference Measurement Procedure (RMP) is the primary reference method for the measurement of total 25(OH)vitamin D. This method separates out the 3-epi-25(OH)vitamin D3 from the 25(OH)vitamin D3, ensuring that the 25(OH)vitamin D3 is not overestimated.
  • A second method by Prof. Linda Thienpont, Ghent University, is also available. It is an ID-LC/MS/MS method for vitamin D in human serum that is traceable to NIST Standard SRM2972.3

CDC Hormone Standardization Program (HoSt)

Ongoing manufacturer certification for vitamin D standardization will be part of the CDC HoSt program, conducted by the CDC’s Clinical Chemistry Branch, Division of Laboratory Services, under the supervision of Hubert W. Vesper, PhD, Director, Clinical Standardization Programs, and Chief, Protein Biomarker Biomarker and Lipid Reference Laboratory. Previous HoSt program assays include testosterone and estradiol.
The CDC Standardization Program for vitamin D is a two-phase process:

  • First, assay manufacturers submit initial sample results for calibration to the standard.
  • Manufacturers then receive quarterly blinded challenges to verify and monitor stability of calibration over time.
  • The performance criteria are a mean bias of 5% and imprecision of 10%.
  • After participants pass four consecutive surveys, they are awarded a certification for a year.4 Renewal is an annual process.
La disponibilidad del ensayo puede variar de un país a otro y está sujeta a los requisitos regulatorios locales.

† www.cdc.gov/labstandards/hs_procedures.html

1

Sempos CT, Vesper HW, Phinney KW, Thienpont LM, Coates PM, Vitamin D Standardization Program (VDSP.) Vitamin D status as an international issue: National surveys and the problem of standardization.  Scandinavian Journal of Clinical & Laboratory Investigation, 2012; 72(Suppl 243): 32 -40

2
Thienpont L, Stepman HCM, Vesper HW. Standardization of measurements of 25-Hydroxyvitamin D3 and D2. Scandinavian Journal of Clinical & Laboratory Investigation, 2012; 72(Suppl 243): 41 -49
3
Scand J Clin Lab Invest. 2012;72(Suppl 243):41-49. 2
4
http://www.cdc.gov/labstandards/hs.html.