Total error vs. measurement uncertainty: revolution or evolution?

Area of Science:

• Clinical Chemistry
• Metrology
• Analytical Performance Goals

Background:

• The 2014 Milan EFLM conference reviewed analytical performance goals, maintaining the Stockholm 1999 hierarchy.
• A critical overview of performance goals and
• total error
• theory by Jim Westgard followed the Milan conference.
• The
• total error
• theory dominates clinical chemistry but faces challenges in broader metrology.

Purpose of the Study:

• To debate the pros and cons of the
• total error
• theory in clinical chemistry.
• To explore methods incorporating all uncertainty causes for medical diagnoses and treatment monitoring.
• To foster an evolutionary approach to performance goal development.

Main Methods:

• Review of the Stockholm 1999 hierarchy and Milan 2014 conference outcomes.
• Analysis of Jim Westgard's critique of performance goals and
• total error
• theory.
• Comparison of
• total error
• theory with generally accepted uncertainty theory.

Main Results:

• The Milan conference rearranged performance goals and established task groups.
• Westgard's critique highlights issues with the Milan conference's approach to
• total error
• theory.
• Uncertainty theory, while accepted, presents mathematical and practical challenges in clinical chemistry.

Conclusions:

• A thorough debate on the
• total error
• theory is necessary.
• Improved methods are needed to integrate all uncertainty sources for clinical decisions.
• Performance goal development should be an evolution, not a revolution.