Review Book

GENERAL COMMENTS ABOUT THE METHOD None EDITORIAL EVALUATION CRITERIA Comments: None Are there any concerns regarding the safety of the method? (if necessary, refer to the review from the Safety Advisor)? No Are there any concerns regarding the data manipulation, data tables or statistical analyses (if necessary, refer to the review from the Statistics Advisor)? See Statistics Advisor report

19. Are there any concerns regarding the data manipulation, data tables, or statistical analysis? Please refer to the review provided by the Statistical Advisor. Reviewer 1 The statistician raises some issues which need attention.

In addition does the homogeneity p-value of 0.43 for un-spiked matrix by the reference method need recalculating? Even if it is correct shouldn't lab. # 3 be excluded from the analysis because it found 1 positive in its uninoculated replicates by the reference method?

Reviewer 2 Reviewer 3 Reviewer 4 Reviewer 5

Revision Pending

NO

There are some provided by the Statistical Advisor.

It would be appreciate to have the final version of the ocument with the statistical modifications during the meeting. Does the statistical design of the study support the applicability statement? (i.e., Do the matrices, analytes and concentrations cover the applicability?) Yes Are there sufficient data points per product/method evaluated (i.e., number of laboratories, number of replicates per laboratory)? Yes If data is pooled, is it clear that variances are homogeneous? Yes If applicable, has statistics been calculated for Sr, SMR, RSDr, RSDR, r, R, HORRAT and Percent Recovery (see Part 6)? Yes If so, have the calculations been done correctly? No Has treatment of outliers (e.g., Cochran and Grubbs tests) been properly addressed in conformity with AOAC guidelines? Yes Have appropriate statistics been calculated correctly? Qualitative Is the table of parameter estimates in AOAC format? Yes Are the inferences/conclusions in line with the statistical parameter estimates? Yes Do the appropriate statistics (or reference to table) appear immediately beneath the title/ applicability of the method? Yes Is the table presented in AOAC format?

Statistics Advisor