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Allowable systematic difference between two instruments measuring the same analyte.

Arne Asberg1, Kristine B Solem, Gustav Mikkelsen

  • 1Department of Clinical Chemistry, Trondheim University Hospital , Trondheim , Norway.

Scandinavian Journal of Clinical and Laboratory Investigation
|June 10, 2014
PubMed
Summary

Defining an allowable systematic difference between two analytical instruments is crucial for accurate patient monitoring. The acceptable difference depends on biological variation and instrument performance, ensuring reliable lab results.

Keywords:
Clinical chemistry testquality controlreproducibility of resultsstatistical modelssystematic bias

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Area of Science:

  • Clinical Laboratory Science
  • Analytical Chemistry
  • Biostatistics

Background:

  • Laboratories often use multiple analytical instruments for the same analyte.
  • Random allocation of patient samples necessitates defining acceptable systematic differences between instruments.

Purpose of the Study:

  • To derive a method for defining the allowable systematic difference between two analytical instruments.
  • To establish criteria for instrument comparison based on total analytical standard deviation (SD).

Main Methods:

  • Developed a formula to estimate the SD of analytical results from two instruments with varying means, SDs, and usage probabilities.
  • Applied the formula to calculate the allowable systematic difference.

Main Results:

  • The allowable systematic difference is influenced by within-subject biological SD, individual instrument SDs, and sample allocation probability.
  • When analytical SDs are minimal, the allowable difference approaches the biological SD; when analytical SDs are maximal, no systematic difference is permitted.

Conclusions:

  • The allowable systematic difference between analytical instruments is contingent upon sample allocation probabilities, analytical SDs, and within-subject biological SD.
  • This framework aids in maintaining analytical quality in laboratory monitoring.