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Recommendations for Setting a Criterion and Assessing Commutability of Sample Materials Used in External Quality

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External quality assessment materials (EQAMs) must be commutable with clinical samples for accurate in vitro diagnostic medical device (IVD-MD) evaluation. This report provides methods for assessing EQAM commutability and acceptable non-selectivity differences between IVD-MDs.

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Area of Science:

  • Clinical Chemistry
  • Laboratory Medicine
  • Metrology

Background:

  • Commutability of external quality assessment materials (EQAMs) with clinical samples is crucial for validating in vitro diagnostic medical devices (IVD-MDs).
  • EQAMs must mimic clinical sample behavior in end-user laboratory settings to ensure reliable performance evaluation.
  • Assessing commutability enables the evaluation of metrological traceability and result equivalence across different IVD-MDs.

Purpose of the Study:

  • To provide recommendations for establishing commutability criteria for EQAMs.
  • To define acceptable differences in non-selectivity between compared IVD-MDs.
  • To outline procedures for performing commutability assessments.

Main Methods:

  • The study defines commutability assessment based on prediction intervals derived from clinical sample distributions.
  • It emphasizes the need for acceptable non-selectivity differences between compared IVD-MDs.
  • Recommendations are provided for modifying the prediction interval criterion using acceptable non-selectivity differences.

Main Results:

  • The report details how to establish criteria for acceptable EQAM commutability.
  • It offers guidance on determining acceptable non-selectivity differences between IVD-MDs.
  • Examples are included for practical application of commutability assessment methods.

Conclusions:

  • Establishing clear criteria for EQAM commutability and acceptable non-selectivity is essential for accurate IVD-MD performance evaluation.
  • The proposed methods facilitate robust commutability assessments, enhancing the reliability of external quality assessment schemes.
  • This work supports the development and validation of IVD-MDs by ensuring comparability of results.