Laboratory Testing Platform for Vitamin D Assay Validated

AACC 2012: The quality of Vitamin D assays was demonstrated based on performance metrics.

With a simple blood test, the Architect 25-OH Vitamin D assay can measure the stable form of Vitamin D (also known as 25-hydroxyvitamin D), which is the body’s repository of Vitamin D.

The Architect 25-OH Vitamin D assay by Abbott (Abbott Park, IL, USA) is a chemiluminescent microparticle immunoassay (CMIA), for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma. The Architect 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency. It is recommended that each laboratory establish its own reference range. Results should be used in conjunction with other data such as symptoms, results of other tests, clinical impressions.

The Vitamin D assay contains method variations; therefore, it is important to apply standardized quality metrics to quality control so that clinicians are confident that they can rely on test results.

A quality-management methodology called Six Sigma was applied by Abbott to its Vitamin D assay to quantify and improve the performance of the lab process and increase the accuracy and reliability of test results.

Mr. Westgard, an expert on quality control and method validation, and an instructor at the Mayo School of Health Sciences, presented on the panel Vitamin D Testing on Wednesday, July 18, 2012, at the American Association for Clinical Chemistry (AACC) Annual Meeting in Los Angeles (CA, USA). He described how the performance of automated 25-OH vitamin D immunoassays was compared to Liquid Chromatography–Mass Spectrometry (LC-MS) techniques.

Sten Westgard, director of client services and technology, Westgard QC, Inc., commented, "Six Sigma provides an objective tool for assessment of laboratory processes, along with quality requirements and performance data. Based on benchmarking evaluation using Sigma metrics, the Abbott ARCHITECT system has demonstrated a range of performance from excellent to world class.

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