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Faktorielle Ringversuche zur Validierung mikrobiologischer Methoden

  • Steffen UhligEmail author
  • Petra Gowik
Generelle Aspekte

Zusammenfassung

In dieser Arbeit wird ein Validierungsansatz für mikrobiologische Methoden vorgeschlagen, bei dem ein Ringversuch mit einem faktoriellen Experiment kombiniert wird. Dieser Ansatz ermöglicht eine deutliche Reduzierung der Anzahl der teilnehmenden Laboratorien: Bei geeignetem Versuchsdesign werden nur 4 anstelle von 8–12 Teilnehmern wie in gewöhnlichen Ringversuchen benötigt. Der Ansatz wird anhand einer Validierung des Arxula adeninivorans Hefe Assay (A-YES) zum Nachweis östrogener Aktivität in Mineralwasser illustriert.

Factorial interlaboratory tests for microbiological measurement methods

Abstract

This paper presents a validation approach for microbiological methods based on a combination of interlaboratory tests and factorial experiments. It requires not more than 4 participants but is achieving comparable statistical confidence as in method validation studies with 8–12 participants, if properly designed. The approach is illustrated by a comprehensive validation of the Arxula adeninivorans yeast estrogen screen (A-YES) assay for the detection of estrogenic activity in mineral water.

Keywords

Interlaboratory test Factorial reproducibility standard deviation Factorial design Method validation Variance components Estrogenic effect 

Notes

Acknowledgments

The authors gratefully acknowledge participation of the laboratories of IPK Gatersleben, TU Dresden, BAM Berlin and quo data Dresden in the factorial interlaboratory study.

References

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Copyright information

© Birkhäuser Verlag, Basel/Switzerland 2009

Authors and Affiliations

  1. 1.quo data GmbHDresdenGermany
  2. 2.Federal Office of Consumer Protection and Food SafetyBerlinGermany

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