GUIDELINES ON PERFORMANCE CRITERIA AND （性能标准和指导方针）.pdfVIP

CAC/GL 74-2010 Page 1 of 22 GUIDELINES ON PERFORMANCE CRITERIA AND VALIDATION OF METHODS FOR DETECTION, IDENTIFICATION AND QUANTIFICATION OF SPECIFIC DNA SEQUENCES * AND SPECIFIC PROTEINS IN FOODS CAC/GL 74-2010 SECTION 1 – INTRODUCTION 1. Molecular and immunological analytical methods are currently the recognized tools for determination of DNA and protein analytes in foods. However, in order for the results obtained by such methods from different laboratories to gain wide acceptability and confidence as reliable, there is need for the analytical methods to satisfy certain quality criteria. 2. These guidelines provide appropriate criteria to validate the performance of methods developed to detect specific DNA sequences or specific proteins in foods. 3. Information relating to general considerations for the validation of methods for the analysis of specific DNA sequences and specific protein is given in the first part of these Guidelines. Specific annexes are provided that contain information on validation of quantitative Polymerase Chain Reaction (PCR) methods, validation of qualitative PCR methods and validation of protein-based methods. SECTION 1.1 – PURPOSE AND OBJECTIVES 4. The goal of this document is to support the establishment of molecular and immunological methods for detection, identification and quantification of specific DNA sequences and specific proteins in foods, which produce results with comparable reproducibility when performed at different laboratories 5. The guidelines are aimed at providing guidance on how to establish methods to detect and identify specific DNA sequences