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Practical aspects concerning validation and quality control for forensic and clinical bioanalytical quantitative methods

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Abstract

Reporting reliable analytical data is the backbone of forensic and clinical bioanalytical research and applications. Therefore, international agreement concerning validation and quality control requirements is needed. Several international guidelines provide a standard for fundamental validation parameters such as selectivity, matrix effects, method limits, calibration, accuracy, precision and stability. However, it is not always easy for the analyst to ‘translate’ these guidelines into practice. International guidelines remain nonbinding protocols that need to be updated according to the type of application and the analyst’s method requirements and depends on the evolution of analytical techniques. In this publication, suggestions for experimental set-up, statistical approaches and straightforward acceptance criteria for validation of forensic bioanalytical applications are suggested. Furthermore, permanent quality control, to ensure state-of-the-art quantitative analytical performances, as well as measurement uncertainty influencing interpretation is discussed.

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Authors and Affiliations

  1. Federal Public Service Justice, National Institute of Criminalistics and Criminology, Vilvoordsesteenweg 100, 1120, Brussels, Belgium

    Sarah M. R. Wille, Vincent Di Fazio & Nele Samyn

  2. Institute of Forensic Medicine, University Hospital Jena, Fürstengraben 23, 07743, Jena, Germany

    Frank T. Peters

Authors
  1. Sarah M. R. Wille
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  2. Frank T. Peters
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  3. Vincent Di Fazio
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  4. Nele Samyn
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Correspondence to Sarah M. R. Wille.

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Wille, S.M.R., Peters, F.T., Di Fazio, V. et al. Practical aspects concerning validation and quality control for forensic and clinical bioanalytical quantitative methods. Accred Qual Assur 16, 279–292 (2011). https://doi.org/10.1007/s00769-011-0775-0

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