QuidelOrtho conducted a study using big data analytics to measure the quality that real VITROS customers experience in their labs today, using the new 2024 CLIA limits where applicable. Results were published in The Journal of Applied Laboratory Medicine by Oxford University, a peer-reviewed publication.
Understanding Six Sigma Metrics
For over 35 years, Six Sigma methodology and strategies have been used by businesses to improve manufacturing and operational quality and minimize variability. Sigma metrics have been adapted for the clinical laboratory by incorporating observed accuracy, precision and total error allowed (TEa).
Sigma metrics offer a valuable approach to quantifying quality. A higher sigma value corresponds to greater accuracy and precision in the measurements of processes being evaluated. Even if the sigma level goes beyond six, it is still referred to as Six Sigma.
The sigma metrics indicate quality/performance levels:
- Six Sigma (World-Class)
- Five Sigma (Excellent)
- Four Sigma (Good)
- Three Sigma (Marginal)
- Two Sigma (Poor)
- Below Two Sigma is Unacceptable
How is our study different?
Our unique approach leverages real lab data from over 2,100 analyzers across 74 countries over an eight-month period to provide authentic insights into VITROS laboratories performance.
115 assays – all quantitative assays included in portfolio included
Publication available in The Journal of Applied Laboratory Medicine published by Oxford University Press
14.8 million individual QC results used
Over 2,000 analyzers across 74 countries
CLIA 2024 limits were given preference – additional limits used from CAP, RCPAQAP, DGKL, AAB, Ricos, and RCPA where CLIA 2024 limits not available
Lab-to-lab, testing on different days, multiple reagent lots, shipping vial-to-vial and material handling
Additional Resources
An introduction to Six Sigma for the Clinical Laboratory.
