Abbott Demonstrates Quality of Vitamin D Assays using Six Sigma Tools

To demonstrate the reliability of its Vitamin D testing, Abbott has announced that it has applied Six Sigma tools to evaluate the performance of its ARCHITECT laboratory testing platform.

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. Some studies have suggested that there is a connection between Vitamin D deficiency and an increased risk of cognitive impairment, osteoporosis, type 2 diabetes, and cardiovascular disease.

Six Sigma is a widely recognized quality-management methodology used by many non-health care industries, such as engineering, banking, and telecommunications, to measure performance. It can help measure quality standards and can be used to improve manufacturing processes. In the area of laboratory diagnostics, Abbott is applying Six Sigma to quantify and improve the performance of lab processes and increase the accuracy and reliability of test results. Some assays, including the Vitamin D assay, contain 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.

"Accuracy in test results is important to improving physician satisfaction and the quality of patient care," said Brian Blaser, executive vice president, Diagnostics Products, Abbott. "Through our Six Sigma programs, we are working closely with customers to help them to build robust quality controls and precisely measure system performance to achieve greater test accuracy."

"As an industry, we need to have better quality control related to Vitamin D assays," said Sten Westgard, Director of Client Services and Technology, Westgard QC, Inc., which provides tools, technology and training for laboratory quality management. "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.