28 No. 2
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.
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
last modified 10 August 2006.
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