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IFCC Working Group Recommendations for Assessing Commutability Part 1: General Experimental Design.

W Greg Miller1, Heinz Schimmel2, Robert Rej3

  • 1Department of Pathology, Virginia Commonwealth University, Richmond, VA; gmiller@vcu.edu.

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|January 20, 2018
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Summary
This summary is machine-generated.

Commutability ensures reference materials (RMs) accurately reflect clinical sample (CS) results across multiple measurement procedures (MPs). This guide details experimental design for assessing RM commutability, crucial for reliable laboratory testing.

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Reference Materials

Background:

  • Commutability is key for reference materials (RMs) to accurately reflect clinical sample (CS) behavior across different measurement procedures (MPs).
  • Ensuring commutability is vital for RMs used in calibration, trueness control, and external quality assessment to guarantee reliable laboratory results.

Purpose of the Study:

  • This report, Part 1 of a series, defines commutability and outlines essential experimental design components for its assessment.
  • It aims to guide the selection of clinical samples, qualification of measurement procedures, and criteria for determining commutability.

Main Methods:

  • The report details critical experimental design factors for commutability assessment.
  • Key considerations include the selection of individual and pooled clinical samples (CSs) and the qualification of measurement procedures (MPs).
  • Establishing clear criteria for determining commutability and generalizing findings are also addressed.

Main Results:

  • Part 1 focuses on the foundational aspects of commutability assessment, defining the property and its importance.
  • It lays the groundwork for subsequent parts by detailing the necessary experimental design considerations.

Conclusions:

  • Proper assessment of reference material (RM) commutability is essential for the integrity of laboratory testing and clinical decision-making.
  • This foundational report provides critical guidance on experimental design for commutability assessment, paving the way for robust statistical analyses in subsequent parts.