AOAC ISPAM Stakeholder Panel Meeting Book 9-24-17

ƒ Example 4: Low Level of Contamination • How many replicates with “0” as the result is acceptable?

Matrix Method

Poultry

Alternative Method

Reference Method

Ct/g Log

Mean

SD Grubbs Ct/g Log Mean SD Grubb s

5 0.7853 3 0.6128 4 0.7076 6 0.8513 2 0.4914

0.6730 3 0.4771 0.5408 0 #NUM! 0.1260 3 0.4771 1.1369 0 #NUM! 1.3951 3 0.4771

#NUM! #NUM! #NUM! #NUM! #NUM!

Low

0.6897 0.1421

#NUM! #NUM!

ƒ Should the limit be the same for the alternative and the reference? ƒ i.e. is the data acceptable for the example above, but if it was reversed and the alternative method had 2 “0” data points, would that be acceptable?

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 Future considerations • Harmonization with ISO 16140-2 Standard