Comparison of international standards concerning the capability of detection for analytical methods

The international standard ISO 11843 specifies the experimental conditions for the estimation of critical values of analytical methods referring to the capability of detection. The present paper aimed at a formal comparison of the ISO 11843 standard with the German standard DIN 32645 and the Commission Decision 2002/657/EC of the EU. In this context the particular scope of each standard is discussed based on a numerical example given in the DIN standard. For practitioners a better understanding of the different guidelines based on the same basics, i.e. the statistical theory of hypothesis testing and the probabilities of false positives α and false negatives β, is to be achieved.

[1]  S. Uhlig,et al.  Assessment of detection methods in trace analysis by means of a statistically based in-house validation concept , 1998 .

[2]  Johanna Smeyers-Verbeke,et al.  Handbook of Chemometrics and Qualimetrics: Part A , 1997 .

[3]  L. A. Currie,et al.  Nomenclature in evaluation of analytical methods including detection and quantification capabilities (IUPAC Recommendations 1995) , 1995 .

[4]  Martina Vandebroek,et al.  Using the correct intervals for prediction: A tutorial on tolerance intervals for ordinary least-squares regression , 2007 .

[5]  The limit of detection is not the analyte level for deciding between “detected” and “not detected” , 2008 .

[6]  Rüdiger Kaus Detection limits and quantitation limits in the view of international harmonization and the consequences for analytical laboratories , 1998 .

[7]  Elio Desimoni About CCα and CCβ as introduced by the Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC , 2004 .

[8]  J. Loco,et al.  Calculation of the decision limit (CCalpha) and the detection capability (CCbeta) for banned substances: the imperfect marriage between the quantitative and the qualitative criteria. , 2007, Analytica chimica acta.

[9]  W. Huber Basic calculations about the limit of detection and its optimal determination , 2003 .

[10]  Edward Voigtman,et al.  Limits of detection and decision. Part 4 , 2008 .

[11]  J. Vogelgesang,et al.  Limits of detection, identification and determination: a statistical approach for practitioners , 1998 .