Quant. MAC Working Group Meeting Book (March 13, 2019)

Priority Sequence – AOAC Mid-Year Meeting 2018

• Number of out of range levels per assay • Recommendations for dealing with discordant results • Difference of Means (Acceptance criteria) • Indicator organism vs. pathogens • Principle of the technology • Determine acceptance criteria for low inoculation level replicates

AOAC Annual Meeting 2018

• Discussion focused on the current acceptance criteria as presented in ISO 16140-2 and the potential for harmonization • A background on the criteria and how it was developed in a collaboration between ISO TC34/SC9 WG2 (statistics) and WG3 (Method Validation) was presented • In summary, ISO 16140-2 combines both the accuracy and the precision of a method and evaluates using a 2 level approach: • Pools standard deviation for all contamination levels • Includes a second criteria if the method is rejected during the first evaluation with AL > 0.5

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