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[Study on commutability evaluation of reference materials for fibrinogen].

Y H Liu1, C B Li2, W B Zhou2

  • 1Graduate School of Peking Union Medical College, National Center for Clinical Laboratories, Beijing Engineering Technology Center of Clinical Laboratory, Beijing Hospital, National Center of Gerontology, Beijing 100730, China.

Zhonghua Yi Xue Za Zhi
|July 19, 2019
PubMed
Summary

The difference in bias approach is recommended for evaluating fibrinogen reference material commutability. WHO International Standard and homemade materials are suitable traceability standards for fibrinogen measurement.

Keywords:
CommutabilityFibrinogenReference material

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Area of Science:

  • Clinical chemistry
  • Biomedical engineering
  • Laboratory medicine

Background:

  • Accurate fibrinogen measurement is crucial for diagnosing and monitoring coagulation disorders.
  • Commutability of reference materials is essential for ensuring reliable inter-laboratory comparisons and diagnostic accuracy.
  • Existing reference materials may exhibit varying performance across different measurement systems.

Purpose of the Study:

  • To evaluate the commutability of reference materials for fibrinogen measurement.
  • To compare different methods for assessing commutability.
  • To identify suitable traceability standards for fibrinogen assays.

Main Methods:

  • Comparative analysis of fibrinogen measurements across Stago STA-R Evolution, Sysmex CS 5100, and IL ACL TOP 700 systems.
  • Evaluation of commutability using Deming regression and the difference in bias approach, adhering to CLSI EP14-A3 and IFCC recommendations.
  • Calibration of measurement systems using the Third WHO International Standard Fibrinogen Plasma (WHO 09/264).

Main Results:

  • The difference in bias approach proved more suitable than Deming regression due to its relevance to clinical requirements.
  • The Third WHO International Standard Fibrinogen Plasma (WHO 09/264) demonstrated commutability across evaluated systems after calibration.
  • Homemade reference materials (RM01, RM02) showed commutability across all system pairs using the difference in bias method.

Conclusions:

  • The difference in bias approach is recommended for commutability evaluation of fibrinogen reference materials.
  • Both the WHO International Standard and validated homemade reference materials can serve as reliable traceability standards.
  • Standardized commutability assessment is vital for inter-laboratory consistency in fibrinogen testing.