I  U  P  A  C

News & Notices

Organizations & People

Standing Committees







Links of Interest

Search the Site

Home Page



Current Project

Chemistry and the Environment Division (VI)
Analytical Chemistry Division (V)


Number: 2005-024-2-600

Title: Establishment of guidelines for the validation of qualitative and semi-quantitative (screening) methods by collaborative trial: a harmonized protocol

Task Group
Christoph von Holst

Members: Elke Anklam (EU, DG-JRC), S. Ellison (UK, LGC and Eurachem), S. Coates (AOAC Int.), A. Fajgelj (AT, IAEA), T. Wenzl (EC, DG JRC), and R. Wood (UK, FSA)

Establishment of an internationally harmonized protocol (guidelines) for the organisation and interpretation of collaborative trials for the validation of qualitative methods.

Background and problem statement
The organization of collaborative trials for the validation of analytical methods requires many important aspects to be taken into account, including the preparation of suitable test materials and the selection of an appropriate protocol for the organisation and interpretation of data from suitable collaborative trials. The protocol should be available as internationally agreed Guidelines. The Guidelines need to provide information as to be 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 now important for an objective assessment to be made on whether a method, once validated, is fit-for purpose and information on how this to 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 (1995), Protocol for the design, conduct and interpretation of method performance studies (Pure and Applied Chemistry 67:331-343 > access PAC content) or the ISO 5725 series of Standards. The Horwitz protocol is, however, only suitable for quantitative methods. As there is current and increasing demand and now availability of so called screening methods (qualitative or semi-quantitative), the existing protocol is not entirely suitable for inter-laboratory validation of such methods. Many problems in food control are only be handled by qualitative or semi-quantitative methods. Examples are PCR based methods for GMO detection and the ELISA based methods for food allergens. Lateral flow devices (dip sticks) have a great application for a rapid screening of food products or industrial production lines. For this reason, a bespoke protocol for screening methods, e.g. those based on immunological or DNA based technologies, is urgently needed. This project will result in suitable guidelines.

The first project group meeting took place in the EC JRC Headquarters in Brussels, Belgium on 20-21 February 2006. All task group members attended the meeting and after some initial presentations related to the state of the art of the qualitative method validation and the work done in this area by some of the participants, the structure of the proposed guidelines was agreed upon and the tasks distributed between the project members. A first draft is expected for 15 March 2006, the co-ordinator will then streamline the draft and completion will be done by electronic exchange.

> May 2006 report update (pdf file - 11KB)

Last update: 21 August 2007


<project announcement published in Chem. Int. Mar-Apr 2006, p. 29>

If you want to update this information, contact us by e-mail
Do not forget to include the Project Number,
your name and relation with that project

Page last modified 21 August 2007.
Copyright ©1997-2007 International Union of Pure and Applied Chemistry.
Questions or comments about IUPAC, please contact, the Secretariat.
Questions regarding the website, please contact web manager.