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Chapter 11 : International Validation, Ring Trial, and Standardization of Rapid Methods

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International Validation, Ring Trial, and Standardization of Rapid Methods, Page 1 of 2

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Abstract:

The need for the food industry to rapidly assess the microbiological quality of raw materials and finished products and the microbiological status of manufacturing procedures has led to the development and refinement of alternative methods that are faster and easier to perform than the corresponding culture-based methods. This chapter outlines a general outlook of the validation procedures to qualitative and quantitative methods. The validation of qualitative and quantitative methods comprises two phases. Phase A, ‘‘Comparative study by an expert laboratory of the alternative method against a reference method,’’ is sometimes referred to as in-house validation by an expert laboratory. Phase B, ‘‘Collaborative study of the alternative method,’’ is carried out in a ring trial organized by the same expert laboratory from Phase A. The selection of food categories and types used within the validation will depend on the type or group of microorganisms and the scope of the validation. Validation can be carried out for a restricted number of food categories, e.g., meat products and milk and dairy products. Then, only these categories require to be studied. In addition to food categories, feed and environmental samples and samples from feces and primary production can be included.

Citation: Qvist S. 2011. International Validation, Ring Trial, and Standardization of Rapid Methods, p 157-161. In Hoorfar J (ed), Rapid Detection, Characterization, and Enumeration of Foodborne Pathogens. ASM Press, Washington, DC. doi: 10.1128/9781555817121.ch11
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References

/content/book/10.1128/9781555817121.ch11
1. Anonymous. 2003. ISO 16140. Microbiology of Food and Animal Feeding Stuffs. Protocol for the Validation of Alternative Methods, ISO TC 34/SC. International Organization for Standardization, Geneva, Switzerland.
2. Anonymous. 2005a. Commission Regulation (EC) No 1688/2005 of 14th October 2005 implementing Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards special guarantees concerning salmonella for consignments to Finland and Sweden of certain meat and eggs. Official Journal of the European Union L 271:1719.
3. Anonymous. 2005b. Commission Regulation (EC) No 2073/2005 of 15th November 2005 on microbiological criteria for foodstuffs. Amended by Commission Regulation (EC) No 1441/2007 of 5th December 2007. Official Journal of the European Union L 338:129.
4. Anonymous. 2007. NMKL Procedure No 20: Evaluation of Results from Qualitative Methods. NMKL, Oslo, Norway.
5. Anonymous. 2008. NMKL Procedure No 8: Measurements of Uncertainty in Quantitative Microbiological Examination of Foods. NMKL, Oslo, Norway.
6. Anonymous. 2009. Protocol for the Validation of Alternative Microbiological Methods. NordVal, Oslo, Norway.
7. AOAC International. 1989. Handbook for AOAC Members, 6th ed. AOAC International, Gaithersburg, MD.
8. AOAC Research Institute. 1989. AOAC Performance Tested Methods. Program. AOAC International, Gaithersburg, MD.
9. Löfström, C.,, M. Krause,, M. H. Josefsen,, F. Hansen, and, J. Hoorfar. 2009. Validation of a same-day real-time PCR method for screening of meat and carcass swabs for Salmonella. BMC Microbiol. 9:85.
10. Malorny, B.,, J. Hoorfar,, C. Bunge, and, R. Helmuth. 2003. Multi-center validation of the analytical accuracy of Salmonella-PCR: towards an international standard. J. Appl. Environ. Microbiol. 69:290296.

Tables

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TABLE 1

Test characteristics that are validated for alternative (rapid) methods

Citation: Qvist S. 2011. International Validation, Ring Trial, and Standardization of Rapid Methods, p 157-161. In Hoorfar J (ed), Rapid Detection, Characterization, and Enumeration of Foodborne Pathogens. ASM Press, Washington, DC. doi: 10.1128/9781555817121.ch11

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