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A multilaboratory-evaluated reference method for the determination of serum sodium

R Schaffer, R A Velapoldi, R C Paule

    Clinical Chemistry
    |November 1, 1981
    PubMed
    Summary

    This study validates a flame atomic emission spectroscopic (FAES) method for serum sodium analysis. The validated FAES method meets rigorous criteria, establishing it as a reliable Reference Method for clinical laboratories.

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    Area of Science:

    • Clinical Chemistry
    • Analytical Chemistry
    • Spectroscopy

    Background:

    • Accurate serum sodium measurement is critical for diagnosing and managing various medical conditions.
    • Existing methods may lack the precision and accuracy required for a definitive Reference Method.
    • Flame atomic emission spectroscopy (FAES) offers potential for precise elemental analysis.

    Purpose of the Study:

    • To evaluate a flame atomic emission spectroscopic (FAES) method for serum sodium determination.
    • To establish FAES as a validated Reference Method for serum sodium analysis.
    • To assess the method's performance against predefined criteria for imprecision and bias.

    Main Methods:

    • A statistically designed, multilaboratory study was conducted.

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  • Serum pools with sodium concentrations ranging from 110-160 mmol/L were analyzed.
  • Definitive sodium values were determined by ion-exchange/gravimetry at the National Bureau of Standards.
  • FAES results were compared against performance criteria: maximum imprecision of 1.5 mmol/L and maximum bias of 2.0 mmol/L.
  • Both manual and semi-automated pipetting techniques were evaluated.

    • Main Results:

    • The FAES method satisfied the predefined performance criteria for a Reference Method.
    • The standard error of a single laboratory's performance ranged from 0.46 to 0.86 mmol/L.
    • The maximum bias observed was 1.0 mmol/L, well within the acceptable limit.
    • Both manual and semi-automated pipetting modes met acceptability criteria.
    • Semi-automated pipetting was selected for the final Reference Method description.
    • Fewer than four replicate analyses were sufficient to meet precision criteria.

    Conclusions:

    • The evaluated flame atomic emission spectroscopic (FAES) method is suitable as a Reference Method for serum sodium.
    • The method demonstrates high precision and low bias, ensuring reliable sodium measurements.
    • Semi-automated pipetting is recommended for optimal performance and reproducibility.
    • The study confirms the utility of FAES in achieving accurate and precise clinical chemistry diagnostics.