AOAC ISPAM Stakeholder Panel Meeting Book 9-24-17

Quantitative Microbiology Validation Acceptance Criteria

Statistical Changes ƒ p value no longer analyzed by ANOVA/t-test ƒ Calculate Difference of Means between candidate and reference method for each contamination level along with 95% Confidence Interval ƒ Mean Difference can be positive or negative ƒ Report the Reverse Transformed Mean Difference and 95% confidence interval ƒ Workbook provided by AOAC – • Has some limitations • Calculates DOM and 95% CIs but not RTDOM or 95% CIs

Current Issues ƒ Guidelines indicated only Valid data should be included! What does valid mean? ƒ No acceptance criteria set for valid data for • Difference of Means • Number of Acceptable Deviations per Validation · i.e. # of out of range levels per assay (1 per every 2-3 matrix?) • Determine Limits for # of acceptable “0” data points for low contamination levels ƒ Need a statistical workbook that can provide all statistical analysis data ƒ Need further guidance for method developers/contract labs/industry on what is required, what the results mean, and are they acceptable