The precision and bias of measurement methods according to EP15 A3

Česká verzia

Authors: J. Ambrožová ¹; J. Kratochvíla ²
Authors place of work: OKB-H Nemocnice Prachatice, a. s ¹; SEKK Pardubice ²
Published in the journal: Klin. Biochem. Metab., 24, 2016, No. 4, p. 183-190

Summary

EP15-A3 document [1] deals with the procedures designed to determine the quantitative measurement procedures analytical performance, namely the user precision verification and the bias estimations that CLSI presents in the form of the recommendations for user as to achieve both goals within a single experiment, which at a minimum allowable range (design) 5x5 takes five days. The paper topic is concerned on the practical user experience with the procedures according to [1], demonstrated here on the albumin example in Annex [11] and identifying the key differences as to the practices described in the previous the EP15-A2 (version A2). A special part of the study presents a comparison of some calculations according to [1] conducted by the means of common Excel software spreadsheets compared with the calculations generated by the special Excel software supplement, namely by the MSA of Analyse-it version 4.51. Two summary tables demonstrate the bias estimates of twenty basic biochemical analytes and eleven specific proteins based on the seven different reference materials measurements.

Keywords:
EP 15-A3, precision verification, trueness estimations, MSA (Analyse-it) application.

Zdroje

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