A Practical Approach toBiological Assay Validation
Joke Ederveen
Sponsored by the Dutch Ministry of Housing, Spatial Planningand the Environment (VROM)
2010
Progress report number 08090
A Practical Approach to Biological Assay Validation
A Practical Approach to Biological Assay Validation
Author:
J.C. Ederveen
Contact:
Joke EderveenProgress, Project Management & EngineeringP.O. Box 60; 2130 AB Hoofddorp, the NetherlandsTel. +31 23 563 5016 / +31 6 4637 7226 j.ederveen@progress-pme.nlwww.progress-pme.nl
Steering committee:
Dr. D.A. Bleijs, RIVM, GMO Office, BilthovenDr. N.A. Kootstra, Academic Medical Center, University of AmsterdamDrs. D. Louz, RIVM, GMO Office, BilthovenDrs. P.C. van Mourik, Sanquin Pharmaceutical Services, AmsterdamDr. B.P.H. Peeters, Central Veterinary Institute, LelystadIng. A.L.M. Wassenaar, RIVM, GMO Office, BilthovenDr. G. van Willigen, Leiden University Medical Center
Sponsor:
This report has been ordered and sponsored by the Dutch Ministry of Housing, SpatialPlanning and the Environment (VROM).
Acknowledgement:
The assistance of Dr. M.A.N. Rits in the preparation of this manuscript is highlyappreciated.Hoofddorp, May 2010
A Practical Approach to Biological Assay Validation
2
Summary
This report is written from the perspective that 'validation‘ is a familiar concept, but inpractice often interpreted and applied in different ways amongst scientists, governmentofficials involved in authorizing experimental laboratory work, and inspectors. Thedocument is meant as practical guide for the execution and implementation of biologicalassay validation in laboratory research.Extensive literature on the subject of assay validation is available, but its content is oftentoo abstract or not specific enough or not useful for the aimed type of research.Therefore, in this report, the basic concepts of 'validation‘ and 'validation performancecharacteristics‘ are explained in simple terms and elucidated by examples.In the report the possible types of assay categories are illustrated and it is shown howeach laboratory experiment can be assigned to one of these categories. Depending onthe purpose of the assay, the relevant characteristics of an assay are determined thathave to be validated.Assay validation is in fact a continuous process. The validation process starts with adescription of the purpose of the method, followed by the development of the assay andthe definition of the performance characteristics. It continues with documentation of themethodology and the validation results. During the in-use phase of the assay, there iscontinuous monitoring to assure that the assay still generates results in accordance withthe performance characteristics as originally determined. Revalidation is applicable if themethod is changed, or has been out of use for a while, when it is applied for anothermaterial or for a new purpose.For clarity, in this report the assay validation process is systematically subdivided in fivedifferent validation phases, which is suitable for validation of biological assays in general.The validation process is demonstrated by detailed, concrete examples of frequently usedbiological assays.
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