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<p>This paper analyzes external quality assessment in the form of interlaboratory comparisons as a&#xa0;tool for performing laboratory proficiency testing and for confirming the level of measurement accuracy required or declared by laboratories. Industry-specific measurement practices in laboratory medicine are highlighted, and the results of long-term participation in an external quality assessment system are analyzed. Based on the analysis, it is concluded that in the absence of appropriate measurement standards, certified reference materials, and reference measurement procedures for many analytes, the system of external quality assessment of medical laboratories takes on a&#xa0;different significance: it becomes an indispensable tool for obtaining objective data on the reproducibility/consistency of results obtained in different laboratories and for identifying biases in the measurement results of participating laboratories. Under such conditions, external quality assessment confirms the proficiency of a&#xa0;medical laboratory in using a&#xa0;specific analytical procedure in conjunction with reference clinical information corresponding to that specific procedure. The obtained results will be useful to specialists working at the intersection of metrology and clinical laboratory diagnostics, as well as to manufacturers of medical devices for <i>in vitro</i> diagnostics and providers of external quality assessment.</p>

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Measurement practices in laboratory medicine and ways to improve external quality assessment

  • 期刊论文

  • 发表日期：

    2025年9月1日

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  • N. A. Kovyazina,
  • N. A. Alkhutova,
  • M. S. Vonsky,
  • A. G. Chunovkina,
  • V. L. Emanuel

摘要

This paper analyzes external quality assessment in the form of interlaboratory comparisons as a tool for performing laboratory proficiency testing and for confirming the level of measurement accuracy required or declared by laboratories. Industry-specific measurement practices in laboratory medicine are highlighted, and the results of long-term participation in an external quality assessment system are analyzed. Based on the analysis, it is concluded that in the absence of appropriate measurement standards, certified reference materials, and reference measurement procedures for many analytes, the system of external quality assessment of medical laboratories takes on a different significance: it becomes an indispensable tool for obtaining objective data on the reproducibility/consistency of results obtained in different laboratories and for identifying biases in the measurement results of participating laboratories. Under such conditions, external quality assessment confirms the proficiency of a medical laboratory in using a specific analytical procedure in conjunction with reference clinical information corresponding to that specific procedure. The obtained results will be useful to specialists working at the intersection of metrology and clinical laboratory diagnostics, as well as to manufacturers of medical devices for in vitro diagnostics and providers of external quality assessment.