Validation of qualitative methods of analysis that use control samples

TrAC - Trends in Analytical Chemistry

Volumn 24, Issue 6, 2005, Pages 516-524

  Trullols, E ^a   Ruisanchez I ^a   Rius, F X ^a   Huguet, J ^b  

^a UNIVERSITAT ROVIRA I VIRGILI   (Spain)

^b Laboratorio de Analisis Dr Echevarne   (Spain)

Author keywords

Binary results; Control samples; Performance quality parameters; Qualitative analysis; Validation

Indexed keywords

ASSAYS; COMPUTATIONAL METHODS; QUALITY CONTROL; RELIABILITY; SCREENING;

QUALITATIVE METHODS; QUALITY PARAMETERS; SPECIFICITY RATES; VALIDATION PROCESS;

CHEMICAL ANALYSIS;

ANALYTIC METHOD; CALCULATION; ENZYME LINKED IMMUNOSORBENT ASSAY; EXAMINATION; LABORATORY DIAGNOSIS; PRIORITY JOURNAL; QUALITATIVE ANALYSIS; RELIABILITY; REVIEW; SAMPLE; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

EID: 20444366944     PISSN: 01659936     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.trac.2005.04.001     Document Type: Article

References (24)

1. International Organization for Standardization, ISO 8402, Quality Management and Quality Assurance. Vocabulary, ISO, Geneva, Switzerland, 1994
2. European Commission, 2002/657/EC: Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results, Off. J. Eur. Commun. L221 (2002) 8 (http://europa.eu.int/eur-lex/)
3. P. Feldsine, C. Abeyta, and W. Andrews J. AOAC Int. 85 2002 1187
4. R. Song, T.J. Fischbach, and K. Ashley Am. Ind. Hyg. Ass. J. 57 1996 161
5. M. Valcárcel, S. Cárdenas, and M. Gallego Trends Anal. Chem. 18 1999 685
6. E. Trullols, I. Ruisánchez, and F.X. Rius Trends Anal. Chem. 23 2004 137
7. E. Trullols, I. Ruisánchez, F.X. Rius, M. Òdena, and M.T. Feliu J. AOAC Int. 87 2004 417
8. J.R. Crowther The ELISA guidebook 2001 Humana Press Totowa, NJ, USA p. 302
9. J.W.A. Findlay, W.C. Smith, J.W. Lee, G.D. Nordblom, I. Das, B.S. DeSilva, M.N. Khan, and R.R. Bowsher J. Pharm. Biomed. Anal. 21 2000 1249
10. European Commission, 2002/257/EC: Commission Regulation of 12 February amending Regulation (EC) No 194/97 setting maximum levels for certain contaminants in food-stuffs and Regulation (EC) No 466/2001 setting maximum levels for certain contaminants in food, Off. J. Eur. Commun. L77 (2001) 1 (http://europa.eu.int/eur-lex/)
11. European Commission, 1998/83/EC: Council Directive (and Corrigendum) of 3 November on the quality of water intended for human consumption, Off. J. Eur. Commun. L330 (1998) 32 (http://europa.eu.int/eur-lex/)
12. Environmental Protection Agency (http://www.epa.gov/)
13. Human Gesellschaft für Biochemica und Diagnostica mbH. Max-Planck-Ring 21, D-65025 Wiesbaden, Germany
14. DiaSorin srl, Anti-HSV-1/Anti-HSV-2 IgG Enzyme Immunoassay Kit, DiaSorin srl, I-13040 Saluggia, Italy
15. Eurachem, Guide to Quality in Analytical Chemistry. An Aid to Accreditation, CITAC/Eurachem Guide, Eurachem, 2002 (http://www.eurachem.ul.pt/ guides)
16. Eurachem, The Fitness for Purpose of Analytical Methods. A Laboratory Guide to Method Validation and Related Topics, Eurachem, 1998 (http://www.eurachem.ul.pt)
17. nternational Organization for Standardization, International Vocabulary of Basic and General Terms in Metrology (VIM), Revision of the 1993 edition, International Vocabulary of Basic and General Terms in Metrology (VIM), ISO, Geneva, Switzerland, 2004 (http://www.abnt.org.br/ISO_DGuide_99999_(E).PDF)
18. National Institute for Biological Standards and Control, 'British Standard Varicella-Zoster antibodies' (http://www.nibsc.ac.uk)
19. Human Gesellschaft für Biochemica und Diagnostica mbH (http://www.human.de/data/gb/vr/el-vzvg.pdf)
20. J.J. O'Rangers, and R.J. Condon J.F. Kay J.D. MacNeil J.J. O'Rangers Current issues in regulatory chemistry 2000 AOAC International Gaithersburg, MD, USA 207
21. D.L. Massart, B.G.M. Vandeginste, L.M.C. Buydens, S. De Jong, P.J. Lewi, and J. Smeyers-Verbeke Data handling in science and technology Handbook of chemometrics and qualimetrics: Part A vol. 20A 1997 Elsevier Science Amsterdam, The Netherlands 436
22. International Organization for Standardization, ISO 3534-1, Statistics, Vocabulary and Symbols, ISO, Geneva, Switzerland, 1993
23. A. RIÍos, D. Barceló, L. Buydens, S. Cárdenas, K. Heydorn, B. Karlberg, K. Klemm, B. Lendl, B. Milman, B. Neidhardt, R.W. Stephany, A. Townshend, A. Zschunke, and M. Valcárcel Accred. Qual. Assur. 8 2003 68
24. A. Pulido, I. Ruisánchez, R. Boqué, and F.X. Rius Trends Anal. Chem. 22 2003 647