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Snap-N-Spike® reference solutions of 25-Hydroxyvitamin D

Over the last decade, vitamin D testing has increased significantly in the clinical laboratory setting as research studies have linked vitamin D deficiency to numerous diseases from diabetes, heart disease, and multiple sclerosis to some cancers.1 Clinical diagnosis and treatment of vitamin D deficiency requires accurate and precise measurements of 25-hydroxyvitamin D (25-OHD) and its 1,25-dihydroxy analog (1,25-OHD). In recent years, clinical laboratories have developed LC-MS/MS methods for quantification of 1,25-OHD and 25-OHD with the potential for greater accuracy and better specificity, especially at the low end of the reference range.

Accurate preparation of a quantitative reference is highly critical for accurate assessment of patient vitamin D levels. Cerilliant certified Snap-N-Spike® solutions are prepared and certified to the highest industry standards including ISO Guide 34, ISO/IEC 17025, and ISO 13485. These solutions are gravimetrically prepared using precision balances which have been qualified to ensure minimal uncertainty. Solutions are flame sealed under argon into ampoules for long term shelf life and rigorously tested to ensure accuracy and shelf life through accelerated and real time studies.

Cerilliant Snap-N-Spike® reference solutions are supported by comprehensive Certificates of Analysis (COA) which provide all analytical data and uncertainty and traceability information to support regulatory requirements. Our COA includes analytical data on homogeneity and accuracy of concentration by comparison to an independently prepared calibration curve.

Materials

     

References

  1. Freeman, J. and Wilson, K. Vitamin D: Progress Toward Standardization, Clinical Laboratory News. 2013 Aug: 39 (8). Accessed on-line November 11, 2013.

 

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