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Vol. 28 No. 2
March-April 2006

The Project Place | Information about new, current, and complete IUPAC projects and related initiatives
See also www.iupac.org/projects

Validation of Qualitative and Semi-Quantitative (Screening)
Methods by Collaborative Trial


Guidelines for method validation need to provide information as to the required number of participating laboratories, characteristics of the test materials to be used in the study, and details on the statistical treatment of the results. It is important to make an objective assessment as to whether a method, once validated, is fit for analysis. Information on how this will be achieved should also be given in the guidelines.

Most quantitative analytical methods, when adopted and published as an international standard, are now required to be validated according to the international harmonized protocol: W. Horwitz, Protocol for the design, conduct, and interpretation of method performance studies [Pure and Applied Chemistry 67, 331–343 (1995)] or the ISO 5725 series of standards.
The Horwitz protocol is suitable only for quantitative methods. As there is a current, increasing demand and the availability of so called screening methods (qualitative or semi-quantitative), the existing protocol is not entirely suitable for interlaboratory validation of such methods. For example, many problems in food control are only being handled by qualitative or semiquantitative methods. For this reason, guidelines for the validation of screening methods, based on immunological or DNA-based technologies, are urgently needed. The aim of this project is to develop suitable guidelines for this purpose.

For more information and comments, contact the task group chairman, Elke Anklam <elke.anklam@cec.eu.int>.

www.iupac.org/projects/2005/2005-024-2-600.html


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