Assessment of detection methods in trace analysis by means of a statistically based in-house validation concept

被引:57
作者
Jülicher, B
Gowik, P
Uhlig, S
机构
[1] Fed Inst Hlth Protect Consumers & Vet Med, EU Reference Lab Residues Vet Drugs, Div Anim Drug Registrat Resid Contr & Feed Addit, D-12277 Berlin, Germany
[2] Free Univ Berlin, Inst Stat & Econometr, D-14195 Berlin, Germany
关键词
validation; calibration; variance component model; power function; uncertainty; trace analysis; residue analysis; limit of detection; critical concentration;
D O I
10.1039/a707281c
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
A matrix-considering in-house validation concept for analytical methods is presented which takes into account the uncertainty due to matrix- and time-induced deviations, It is based on a variance component model for univariate quantitative measurement data that can be adapted to both screening and confirmation methods and to both zero-tolerance and threshold decisions, The model allows the calculation of critical concentrations for given a-errors and the calculation of the corresponding power function to evaluate the performance of an analytical method. The model is applied to a real-life validation experiment.
引用
收藏
页码:173 / 179
页数:7
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