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Related Experiment Videos

The how and why of an accuracy base for proficiency testing programs.

M J Welch1, H S Hertz

  • 1Center for Analytical Chemistry, National Bureau of Standards, Gaithersburg, MD 20899.

Archives of Pathology & Laboratory Medicine
|April 1, 1988
PubMed
Summary

The National Bureau of Standards developed precise definitive methods for measuring serum analytes. These methods improve clinical laboratory accuracy by certifying reference materials and identifying biases in routine testing.

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Area of Science:

  • Clinical Chemistry
  • Analytical Chemistry
  • Biomedical Measurement

Background:

  • The National Bureau of Standards (NBS) has a decade-long history of developing definitive measurement methods for human serum analytes.
  • These methods are crucial for ensuring accuracy in clinical laboratory diagnostics.

Purpose of the Study:

  • To develop and validate high-precision, accurate definitive methods for key serum analytes.
  • To certify reference materials for use in clinical laboratory proficiency testing programs.
  • To assess the accuracy of routine clinical laboratory methods through comparison with definitive values.

Main Methods:

  • Utilized isotope dilution mass spectrometry (IDMS) for precise and accurate analyte quantification.
  • Developed a modified definitive method for cholesterol using a cholesterol-13C3 labeled internal standard.

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  • Employed capillary gas chromatography and novel electrical ion switching for enhanced cholesterol measurement.

    • Main Results:

    • Definitive methods provide highly accurate and precise measurements for serum analytes.
    • Reference serum pools certified using definitive methods aid in assessing clinical laboratory accuracy.
    • While grand mean values in proficiency testing align with definitive values, some peer groups exhibit significant biases.
    • The modified cholesterol method demonstrated precision and lack of significant bias on Standard Reference Material 909.

    Conclusions:

    • Definitive methods are essential for establishing accurate reference values in clinical chemistry.
    • Proficiency testing programs, informed by definitive methods, are vital for identifying and correcting biases in routine laboratory testing.
    • Continuous improvement of definitive methods, such as the enhanced cholesterol assay, further refines measurement accuracy in healthcare.