Transcription of Appendix M: Validation Procedures for …
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Appendix M: Validation Procedures for …
2012 AOAC INTERNATIONALA lthough there are a number of documents published on method Validation (1, 2) which target analytical methods in general, and there are numerous publications on Validation of ELISA methods for pesticides, these documents do not address specifi c areas of concern for food allergen analysis, such as reference materials, spiking methods, or choice of matrixes. In the absence of a universally recognized reference standard for food allergen ELISAs, many organizations and end-users use different Validation protocols and different analytical standards. Such inconsistency and duplication inevitably has a negative economic impact on the food allergen community. This document is designed to accompany the AOAC Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of Analysis (1), and to provide guidance specifi c to the Validation of quantitative ELISA-based methods for food allergens.
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