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Analytical goals for rectilinear calibration functions

X Fuentes-Arderiu1, P Alía, I Machuca

  • 1Servei de Bioquímica Clínca, Hospital Prínceps d'Espanya, L'Hospitalet de Llobregat, Barcelona, Spain.

Clinica Chimica Acta; International Journal of Clinical Chemistry
|January 31, 1994
PubMed
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This study proposes new analytical goals for assessing rectilinearity in calibration functions, focusing on biological variation. The proposed method compares systematic error to allowable total error, ensuring clinical relevance for measurement procedures.

Area of Science:

  • Clinical Chemistry
  • Analytical Chemistry
  • Biostatistics

Background:

  • Establishing analytical goals for rectilinearity based on within-subject biological variation is currently lacking.
  • Existing statistical tests for evaluating rectilinearity may be overly restrictive for practical clinical applications.

Purpose of the Study:

  • To propose a new analytical goal for rectilinearity that considers within-subject biological variation.
  • To provide a method for evaluating calibration functions when statistical tests reject rectilinearity, focusing on clinical acceptability of systematic error.

Main Methods:

  • Comparing the systematic error of a least-squares regression line (used as a calibration function) against the allowable total error when rectilinearity is statistically rejected.
  • Defining the maximum allowable systematic relative error (LoRi) based on the within-subject biological coefficient of variation (C.V.Bw) and the between-run metrological coefficient of variation (C.V.M).

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Main Results:

  • The proposed goal for rectilinearity is defined as LoRi < C.V.Bw -1.96 C.V.M.
  • This goal ensures that the systematic error introduced by a non-rectilinear calibration function is within acceptable clinical limits, considering biological variability.

Conclusions:

  • The proposed analytical goal for rectilinearity offers a more clinically relevant approach than traditional statistical tests.
  • This framework helps in determining the acceptability of calibration functions in the presence of non-rectilinearity, balancing analytical precision with biological variation.