Analytical performance specifications for changes in assay bias (Δbias) for data with logarithmic distributions as assessed by effects on reference change values

Per H. Petersen, Flemming Lund (Lead / Corresponding author), Callum G. Fraser, György Sölétormos

    Research output: Contribution to journalArticlepeer-review

    3 Citations (Scopus)

    Abstract

    Background: The distributions of within-subject biological variation are usually described as coefficients of variation, as are analytical performance specifications for bias, imprecision and other characteristics. Estimation of specifications required for reference change values is traditionally done using relationship between the batch-related changes during routine performance, described as Δbias, and the coefficients of variation for analytical imprecision (CVA): the original theory is based on standard deviations or coefficients of variation calculated as if distributions were Gaussian. 

    Methods: The distribution of between-subject biological variation can generally be described as log-Gaussian. Moreover, recent analyses of within-subject biological variation suggest that many measurands have log-Gaussian distributions. In consequence, we generated a model for the estimation of analytical performance specifications for reference change value, with combination of Δbias and CVA based on log-Gaussian distributions of CVI as natural logarithms. The model was tested using plasma prolactin and glucose as examples. 

    Results: Analytical performance specifications for reference change value generated using the new model based on log-Gaussian distributions were practically identical with the traditional model based on Gaussian distributions. 

    Conclusion: The traditional and simple to apply model used to generate analytical performance specifications for reference change value, based on the use of coefficients of variation and assuming Gaussian distributions for both CVI and CVA, is generally useful.

    Original languageEnglish
    Pages (from-to)686-691
    Number of pages6
    JournalAnnals of Clinical Biochemistry
    Volume53
    Issue number6
    Early online date3 May 2016
    DOIs
    Publication statusPublished - 1 Nov 2016

    Keywords

    • Analytical imprecision
    • analytical performance specifications
    • interbatch systematic variation
    • logarithmic distributions
    • reference change values
    • within-subject biological variation

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