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Indirect reference limits estimated from patients' results by three mathematical procedures.

M Ferré-Masferrer1, X Fuentes-Arderiu, R Puchal-Añe

  • 1Servei de Bioquímica Clinica, Ciutat Sanitària i Universitària de Bellvitge, Barcelona, Spain.

Clinica Chimica Acta; International Journal of Clinical Chemistry
|March 4, 1999
PubMed
Summary

Clinical laboratories can estimate indirect reference limits from patient data using statistical methods. While generally reliable for many biochemicals, this approach showed limitations for specific analytes like bilirubin and potassium.

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Area of Science:

  • Clinical Chemistry
  • Biostatistics
  • Laboratory Medicine

Background:

  • Most clinical laboratories rely on literature-reported reference intervals, which may not accurately reflect local patient populations.
  • Establishing in-house reference values is resource-intensive, creating a need for alternative methods.

Purpose of the Study:

  • To evaluate the reliability of indirect reference limit estimation using mathematical/statistical procedures on routine patient results.
  • To compare indirect reference limits with those derived from reference samples following International Federation of Clinical Chemistry (IFCC) guidelines.

Main Methods:

  • Applied Bhattacharya, Martin, and Kairisto et al. procedures to 14 biochemical quantities using routine laboratory patient data.
  • Validated indirect reference limits by statistical comparison against IFCC-recommended reference limits derived from a reference sample.

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Main Results:

  • Indirect reference limits were found to be reliable for most of the 14 biochemical quantities studied.
  • The procedures were unsuitable for estimating indirect reference limits for bilirubins, potassium ion concentrations, and alanine and aspartate aminotransferase catalytic concentrations.

Conclusions:

  • Indirect reference limits can be reliably estimated from routine patient results for many biochemicals, provided distribution skewness and kurtosis are not excessive.
  • Factors beyond distribution shape influence the accuracy and suitability of these indirect estimation methods.