[Normal ranges and accuracy of laboratory analyses]

Area of Science:

• Clinical chemistry
• Laboratory medicine
• Biomarker analysis

Context:

• Establishing definitive laboratory normal ranges for health and disease is inherently uncertain.
• Analytical and preanalytical errors contribute to the variability of laboratory test results.
• Existing population-based reference intervals may not fully capture individual health status.

Purpose:

• To address the challenge of establishing precise normal ranges for laboratory indices.
• To propose a model for interpreting laboratory results that accounts for uncertainty.
• To enhance the accuracy of diagnostic conclusions based on laboratory analyses.

Summary:

• Laboratory results possess an inherent uncertainty, making a strict distinction between health and disease difficult.
• A three-zone interpretation model (health, disease, intermediate) is proposed, similar to blood glucose and cholesterol guidelines.
• The statistical shift scattering method is recommended for assessing analytical and preanalytical errors, improving the assessment of uncertainty.

Impact:

• This approach can lead to more nuanced and accurate interpretations of laboratory diagnostics.
• It provides a framework for understanding the probabilistic nature of diagnostic conclusions.
• The proposed methods aim to refine the definition and application of reference intervals in clinical practice.