EmpleoRelaciones con InversoresComunicados de Prensa
  1. Siemens Healthineers Latinoamérica
  2. Especialidades Clínicas y Enfermedades
  3. Ensayos del metabolismo óseo
  4. Ensayo Dimension EXL de Vitamina D Total

Ensayo Dimension EXL de Vitamina D Total

Dimension EXL

Siemens Healthineers ahora ofrece un Ensayo LOCI® Vitamin D Total * en los Sistemas Integrados de Química Dimension® EXL ™. Este ensayo permite a los laboratorios proporcionar resultados de 25 (OH) vitamina D altamente precisos (~ 100% D2 y D3) con un tiempo de respuesta rápido. La prueba de vitamina D ahora se puede consolidar con pruebas de rutina en un sistema químico integrado completamente automatizado, de alto rendimiento.
 

  • Proporciona una excelente sensibilidad para un diagnóstico diferencial más preciso de la insuficiencia de vitamina D y una mejor atención al paciente.
  • Proporciona un tiempo de respuesta rápido- 31 minutos para el primer resultado.
  • Ofrece un buen reactivo y estabilidad de calibración para mejorar la eficiencia operativa y laboral con menos tiempo de trabajo.
  • Permite la consolidación de la carga de trabajo de pruebas rutinarias y especializadas para aumentar la productividad.

 

La demanda de pruebas de vitamina D sigue creciendo, impulsada por las investigaciones emergentes sobre la importancia de la vitamina D para el bienestar. Estudios recientes muestran que a nivel mundial, más de mil millones de personas son deficientes en vitamina D, y las tasas de deficiencia han aumentado porque las personas han limitado su exposición al sol debido al riesgo de cáncer de piel. La deficiencia de vitamina D se ha asociado durante mucho tiempo con raquitismo en niños y osteomalacia en adultos, y la insuficiencia a largo plazo de calcio y vitamina D conduce a la osteoporosis. Sin embargo, en los últimos años, la vitamina D se ha convertido en un ensayo de estado general de salud, y han habido múltiples publicaciones vinculando deficiencia de vitamina D a varios estados de enfermedad, como el cáncer, cardiovascular, diabetes y enfermedades autoinmunes.

La medición de la vitamina D total puede ayudar en la interpretación correcta del estado de salud general de los pacientes.

Assay Specifications

Assay Specifications

Dimension EXL LOCI Vitamin D Total Assay**

Sample Type

Serum, Lithium Heparin Plasma, EDTA Plasma

Sample Volume

8 µL

Assay Range

5.0 – 150.0 ng/mL [12.5 – 375.0 nmol/L]

Limit of Quantitation

5.0 ng/mL [12.5 nmol/L]

Calibration Interval

7 days

Onboard Stability

30 days

Time To First Result

31 minutes

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 SRM2972.1

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.2 Renewal is an annual process.

* No disponible para la venta en EE.UU. La disponibilidad de los ensayos puede variar de un país a otro.

** Not available for sale in the U.S. Assay availability may vary from country to country.

1

Holick MF. Deficiencia de vitamina D. N Engl J Med. 2007; 357 (3): 266-81.

2

National Institutes of Health, Office of Dietary Supplements. Dietary supplemental fact sheet: vitamin D. Updated 11/13/2009. Accessed 08/17/2010.Accessed 08/17/2010.