AOAC RI ERP Final Action Recommendations eBook

AOAC EXPERT REVIEW PANEL FOR MICROBIOLOGY FOR FOODS AND ENVIRONMENTAL SURFACES AOAC Expert Review Panel Final Action Feedback

o Guidance and support can be obtained from the AOAC Safety Committee.

Safety committee approved the method before the collaborative study was initiated. Microbiological safety precautions are addressed in the OMA manuscript and in the method package insert, both of which were reviewed and approved by the AOAC reviewers. REFERENCE MATERIALS o Document efforts undertaken to locate reference materials. Methods may still progress to Final Action even if reference materials are not available. NA SINGLE-LABORATORY VALIDATION o Data demonstrating response linearity, accuracy, repeatability, LOD/LOQ, and matrix scope must be present. Experimental designs to collect this data may vary with the method protocol and the intended use of the method. This method was independently validated by AOAC RI and AOAC OMA involving both single multi-laboratory evaluations and meeting statistical acceptance criteria for each validation organization. REPRODUCIBILITY/UNCERTAINTY AND PROBABILITY OF DETECTION o Do you have any information that supports regarding the reproducibility of this method as written? If so, please specify and submit information. This method was independently validated by AOAC RI and AOAC OMA involving both single and multi-laboratory evaluations and meeting the statistical acceptance criteria for approval from each validation organization. ADDITIONAL FEEDBACK FROM USERS OF METHOD o Based on your experience with the method, are there any recommended changes to the AOAC First Action method as written? no o Document positive and negative feedback from users of the method during the trial period regarding the apparatus and reagents, general instructions, enrichment, results and interpretation, confirmation, etc. see below o Resources can be identified by the AOAC Statistics Committee. NA

o Feedback from users demonstrating method ruggedness should be documented. o Access to the future availability of vital equipment, reference materials, and supplies.

VITEK® 2 GP is a proprietary bioMérieux test kit that is commercially available worldwide. VITEK® 2 Gram Positive (GP) Identification card for use with the VITEK® 2 automated microbial identification system is used in both clinical and industry laboratories worldwide. It has been extensively tested in FDA clinical trials. The method is approved for use in the USDA/FSIS MLG. The VITEK 2 GP method has received independent 3 rd party approvals from AOAC RI and AOAC OMA demonstrating reproducibility, repeatability, robustness and overall reliability in both single independent laboratory testing and in an

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