AOAC ISPAM Quant. Micro Acceptance Criteria 6-28-18

ƒ Develop working group to review and develop Acceptance Criteria ƒ Identify acceptance criteria for current statistical analysis including: • Difference of Means • # of out of range levels per assay (1 per every 2-3 matrix?) • Develop workbook to cover statistical analysis • Conduct workshop with Expert Review Panel Members, Independent Labs and Diagnostic Manufacturers

ƒ Example 2: Method Developer Study for Multiple Matrices. • Two Level with a statistical difference according to workbook for one matrix

95% Confidence Intervals (LCL, UCL) (Log 10 ) -0.245 0.175 -0.200, -0.025 -0.857, -0.540 -0.1627, 0.5780 -0.0048, 0.1789 -0.0307, 0.0612 -0.1299, 0.1472 -0.0368, 0.0316 -0.0730, 0.1215 -0.1288, 0.6960 -0.0988, 0.0602 -0.0699, 0.0073 -0.0132, 0.1601 -0.0852, 0.1654 -0.0664, 0.2310 -0.0330, 0.1181 -0.0557, 0.1181 -0.0068, 0.0812

Mean Difference a (Log 10 )

Contamination Level

Reference Method

Matrix

Low

-0.035 -0.512 -0.698 0.3703 0.0919 0.0152 0.0087 -0.0026 0.0242 0.4124 -0.0193 -0.0313 0.0866 0.0401 0.0823 0.0426 0.0312 0.0440

Poultry

FDA/BAM

Medium

High Low High Low High Low High Low High Low

Salad Dressing

Medium

FDA/BAM

Fresh Pasta

Medium

FDA/BAM

Ice Cream

Medium

SMEDP

Milk Powder

Medium

SMEDP

Milk

Medium

SMEDP

High