||I U P A C
Organizations & People
and the Environment Division (VI)
Analytical Chemistry Division
WORKING PARTY ON HARMONIZATION OF QUALITY ASSURANCE
Title: Establishment of guidelines
for the validation of qualitative and semi-quantitative (screening)
methods by collaborative trial: a harmonized protocol
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 >
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)
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