By Peter Bedson, Helen Parkes, V (Ginny) Saunders, Sue Upton
Introduces the problems of validation and caliber to the bioanalytical group, particularly addressing DNA-based analyses. Designed to elevate knowledge of the standards which may impact the validity of DNA research and the creation of extra demanding situations which are linked to the research of actual samples. Spiral.
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1983. Validation of analytical methods. Anal. Chem. 55: 600A-608A. 4. The Manager’s Guide to VAM. September 1996. Produced by LGC and NPL on behalf of the DTI. 5. IUPAC Compendium of Chemical Technology. 1985. Blackwell, Oxford. 6. I S 0 3534-1. 7. Davies, C. 1994. Concepts. In: The Immunoassay Handbook (ed. ), pp. 83116. Stockton Press, New York. 8. Smith, M. 1994. Method evaluation. In: The Immunoassay Handbook (ed. ), pp. 256-262. Stockton Press, New York. 9. Pappas, M. G. 1994. Biotechnology product development.
6) offer the opportunity to conpare in-house results to analyses carried out in other laboratories. Analytical measurements made in one locatior should be consistent with those elsewhere. 7). These should be emp oyed on a regular basis. Organisations making analytical measurement i should have well deJined quality control (QC) and quality assurance (ell)procedures. QA schemes can assist in preventing errors by ensuring thxt trained staff, calibrated equipment, quality protocols and valid methodologies are used.
If so, certain sample preparation steps may be required that will remove contaminants. 2. The composition of the sample: 0 Is the sample heterogeneous with respect to the analyte and matrix components? If so, preparation steps may be required to homogenise the sample or sampling issues should be addressed. 0 Is the analyte contained in a matrix whose components are well characterised with respect to potential inhibitors or extraction strategies? If so, an existing extraction process could be adapted and optimised.
Analytical Molecular Biology by Peter Bedson, Helen Parkes, V (Ginny) Saunders, Sue Upton