Keywords
qualitative methods
performance parameters
How to Cite
Abstract
The growing importance of qualitative analysis and the need for reliable analytical results in order to support the decision making at various sectors of food chain are unquestionable, with impacts on the economy, public health and consumer rights. However, the validation of these methods has been a critical point in the quality management systems implementation, and also in the processes for laboratory accreditation. In spite of the existence of well-established protocols for the validation of quantitative methods, there is a gap in the development of approaches for the implementation of metrology in the qualitative analysis. In this context, this paper deals with the validation of qualitative methods, including definitions, experimental design, and analysis of results for evaluating the applicable performance parameters, such as false response rates, reliability, selectivity, sensitivity, detection limit, region of unreliability, accordance, concordance and robustness.
References
1. Souza SVC. Procedimento para validação intralaboratorial de métodos de ensaio: delineamento e aplicabilidade em análises de alimentos [tese de doutorado]. Belo Horizonte (MG): Universidade Federal de Minas Gerais; 2007.
2. Associação Brasileira de Normas Técnicas – ABNT. ISSO (International Standard Organization). ABNT NBR ISO/IEC 17025. Requisitos gerais para a competência de laboratório de ensaio e calibração. Rio de Janeiro: ABNT; 2005. 31p. (b)
3. Brasil. Ministério da Agricultura, Pecuária e Abastecimento/Secretaria de Defesa Agropecuária. Instrução normativa número 8, de 29 de abril de 2010. Diário Oficial [da] União. Brasília, DF. 03 mai 2010; Seção 1, p. 27-30.
4. Aguilera E, Lucena R, Cárdenas S, Valcárcel M, Trullols E, Ruisánchez I. Robustness in qualitative analysis: a practical approach. Trends Anal Chem. 2006; 26(6):621-7.
5. Pulido A, Ruisánchez I, Boqué R, Rius FX. Uncertainty of results in routine qualitative analysis. Trends Anal Chem. 2003; 22(10):647-54.
6. Trullols E, Ruisánchez I, Rius FX. Validation of qualitative analytical methods. Trends Anal Chem. 2004; 23(2):137-45.
7. King B. In-house method validation. A guide for chemical laboratories. LGC Limited; 2003.
8. Ellison SLR, Fearn T. Characterising the performance of qualitative analytical methods: Statistics and terminology. Trends Anal Chem. 2005; 24(6):468-76.
9. Peters FT, Drummer OH, Musshoff F. Validation of new methods. Forensic Sci Int. 2007; 165:216-24.
10. Instituto Nacional de Metrologia, Normalização e Qualidade Industrial - INMETRO. DOQ-CGCRE-008. Orientações sobre validação de métodos de ensaios químicos. Rio de Janeiro: INMETRO; 2010. 35p.
11. EURACHEM. The fitness for purpose of analytical methods, a laboratory guide to method validation and related topics. Teddington: LGC; 1998. 61p.
12. European Commission - EC. Commission decision 2002/657/EC of 12 August 2002. Implementing Council Directive 96/23/EC concerning performance of analytical methods and the interpretation of results. Official Journal of the European Communities; 2002, L221/8.
13. Thompson M, Ellison SLR, Wood R. Harmonized guidelines for single-laboratory validation of methods of analysis. Pure Appl Chem. 2002; 74:835-55.
14. Ríos A, Téllez H. Reliability of binary analytical responses. Trends Anal Chem. 2005; 24(6):509-15.
15. Valcárcel M, Cárdenas S. Modern qualitative analysis. Trends Anal Chem. 2005; 24(6):467.
16. Valcárcel M, Ríos A. Traceability in analytical chemistry. Analyst. 1995; 120:2291-7.
17. Cárdenas S, Valcárcel M. Analytical features in qualitative analysis. Trends Anal Chem. 2005; 24(6):477-87.
18. Ríos A, Barceló D, Buydens L, Cárdenas S, Heydorn K, Karlberg B et al. Quality assurance of qualitative analysis in the framework of the European project ‘MEQUALAN’. Accred Qual Assur. 2003; 8:68–77.
19. Unger-Heumann M. Strategy of analytical tests kits. Fresenius' J Anal Chem. 1996; 354(7-8):803-6.
20. Valcárcel M, Cárdenas S, Gallego M. Sample screening systems in analytical chemistry. Trends Anal Chem. 1999; 18(11):685-94.
21. Brasil. Ministério da Agricultura, Pecuária e Abastecimento/Secretaria de Defesa Agropecuária. Instrução normativa número 24, de 14 de julho de 2009. Diário Oficial [da] União. Brasília, DF, 22 jul 2009; Seção 1, p. 7-15.
22. European Commission – EC. Community Reference Laboratories residues (CRLs). Guidelines for the validation of screening methods for residues of veterinary medicines (initial validation and transfer). [acesso 2011 Jan 06]. Disponível em: [http://ec.europa.eu/food/food/chemicalsafety/residues/Guideline_Validation_Screening_en.pdf ].
23. AOAC (AOAC Research Institute). AOAC® Performance Tested MethodsSM Program, Policies and procedures. [acesso 2011 Jan 20]. Disponível em: [www.aoac.org/testkits/Policies%20&%20Procedures.pdf ].
24. Raugel P. Rapid food analysis and hygiene monitoring: kits, instruments, and systems. Berlim: Springer-Verlag; 1999.
25. CODEX ALIMENTARIUS. ALINORM 10/33/23. Joint FAO/WHO Food Standards Programme Codex Alimentarius Commission Thirty-third Session, Genebra, 2010 – Report of the thirty-fist session of the Codex Committee on methods of analysis and sampling, Budapeste, 2010.[acesso 2011 Jan 06]. Disponível em:[ www.codexalimentarius.net/download/report/738/al33_23e.pdf ].
26. Trullols E, Ruisánchez I, Rius FX, Huguet J. Validation of qualitative methods of analysis that use control samples. Trends Anal Chem. 2005; 24(6):516-24.
27. Milman BL, Konopelko LA. Uncertainty of Qualitative Chemical Analysis: General Methodology and Binary Test Methods. J Anal Chem. 2004; 59(12):1128–41.
28. Simonet BM, Ríos A, Valcárcel M. Unreliability of screening methods. Anal Chim Acta. 2004; 516:67-74.
29. Currie LA. Nomenclature in evaluation of analytical methods inlcuding detection and quantification capabilities. Pure Appl Chem. 1995; 67:1699-723.
30. Valcárcel M, Ríos A. Is traceability an exclusive property of analytical results? An extended approach to traceability in chemical analysis. Fresenius' J Anal Chem. 1997; 359: 473–5.
31. Langtonn SD, Chevennement R, Nagelkerke N, Lombard, B. Analysing collaborative trials for qualitative microbiological methods: accordance and concordance. Int J Food Microbiol. 2002; 75:175-81.32.
32. Gowik P. The validation of methods for regulatory purposes in the control of residues. J Chromatogr A. 2009; 1216:8051–8.
33. Armstrong N, Hibbert DB. An introduction to Bayesian methods for analyzing chemistry data. Part 1: An introduction to Bayesian theory and methods. Chemom Intell Lab Syst. 2009; 97:194-210.
34. Ellison SLR, Gregory S, Hardcastle WA. Quantifying uncertainty in qualitative analysis. Analyst. 1998; 123:1155-61.
35. Henderson AR. Assessment of clinical enzyme methodology: a probabilistic approach. Clin Chim Acta. 1997; 257:25-40.
36. Song R, Schlecht PC, Ashley K. Field screening test methods: performance criteria and performance characteristics. J Hazardous Mater. 2001; 83: 29-39.
37. Milman BL, Konopelko LA. Identification of chemical substances by testing and screening of hypotheses. Fresenius' J Anal Chem. 2000; 367:621-8.
38. Ellison SRL. Uncertainties in qualitative testing and analysis. Accred Qual Assur. 2000; 5:346–8.
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