By Peter Bedson, Helen Parkes, V (Ginny) Saunders, Sue Upton

Introduces the problems of validation and caliber to the bioanalytical neighborhood, in particular addressing DNA-based analyses. Designed to elevate know-how of the criteria that could impact the validity of DNA research and the construction of extra demanding situations which are linked to the research of genuine samples. Spiral.

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In some circumstances it may be prudent to surface-clean or sterilise a sample, for example if the target organism is contained within a matrix or higher organism which could have been externally contaminated. Selective separation of the sample could also take place at this stage. 2 In order to achieve this, it may be necessary to homogenise heterogeneous samples in a blender or mortar and pestle before analysis. Alternatively, a minimum sample mass or size should be employed, thereby reducing the amount of misrepresentative sampling that may occur if a much smaller heterogeneous selection is made.

Biotechnology product development. In: The Biotech Business Handbook, pp, 134-139. Humana Press, Totowa, NJ. 10. Youden, W. J. and Steiner, E. H. 1975. Statistical Manual of the Association of Official Analytical Chemists. AOAC, Washington. 11. , McLeod, N. and Reed, K. 1991. Appendix C. In: DNA Profiling. Principles, Pitfalls and Potential. Harwood Academic Publishers, Switzerland. 12. Accreditation for chemical laboratories: guidance on the interpretation of the EN45000 series of standards and ISO/IEC guide 25.

2 VAM Principles The role of the VAM Initiative supported by the Department of Trade and Industry is to promote the production of quality data. These ~ principles, set out below, are in no way intended to replace, contradict or diminish the quality assurance, quality control or accreditation schemes that may be in place. In fact, a positive requirement for such schemes is supported by the principles. Analytical measurements should be made to satisfy an agreed requirement. Analysis is generally undertaken to answer a specific question or to provide a solution to a problem.

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