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Limitations to the development of Milan model 1b analytical performance specifications
1Department of Chemical Pathology, SydPath, St Vincent's Hospital, Darlinghurst, NSW, Australia.
Clinical Chemistry and Laboratory Medicine
|May 9, 2026
Summary
Analytical Performance Specifications (APS) using the Milan model 1b are limited by "state of the art" definitions. Understanding these limitations is crucial for accurate clinical decision-making in laboratory medicine.
Area of Science:
- Laboratory Medicine
- Clinical Chemistry
- Medical Diagnostics
Background:
- The Milan models provide a framework for setting Analytical Performance Specifications (APS) in laboratory medicine.
- Milan model 1b bases APS on patient classification and clinical decision-making, linking these to patient outcomes.
Purpose of the Study:
- To describe limitations of APS derived using Milan model 1b.
- To incorporate insights from Milan model 2 (biological variation) and model 3 ("state of the art").
Main Methods:
- Analysis of limitations inherent in Milan model 1b.
- Consideration of "state of the art" definitions in relation to routine availability and outcome studies.
- Integration of biological variation data.
Main Results:
- The definition of "state of the art" impacts clinical survey studies and the routine implementation of APS.
- When "state of the art" refers to outcome study methods, it limits the ability to support smaller assay precision.
- Assay performance is only one factor influencing the link between laboratory results and clinical findings.
Conclusions:
- Milan model 1b is valuable for assigning clinical meaning to assay performance.
- Awareness of "state of the art" limitations is essential when interpreting outcomes from model 1b studies.
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