AOAC ISPAM Stakeholder Panel Meeting Book (August 26, 2018)

Action Item #1-A ƒ Working Group (WG) 2 (statistical analysis), developed the accuracy profile to be included in ISO 16140-2. ƒ The design was discussed at the WG2 level and then sent to WG3 (method validation) for approval, rejection or modification. • The accuracy profile (AP) combines both the accuracy and the precision of a method. ƒ The acceptability limits for the accuracy profile were established in a theoretical way, although existing data based on the 16140, 2003 version were included (150 Simulations + 37 ILS data from MicroVal/AFNOR) ƒ Important for the study design:

• Same # of replicates for both methods • Focus on repeatability/reproducibility.

ƒ A two step approach was settled to allow for the rejection of alternative methods due to a large variation between results than the reference method.

Action Item #1-A

Initial procedure AP: •

ĂůĐƵůĂƚĞ ɴ-ETI (80 %) at each level

• ĐĐĞƉƚ ĂůƚĞƌŶĂƚŝǀĞ ŵĞƚŚŽĚ ŝĨ Ăƚ ĞĂĐŚ ůĞǀĞů ɴ-ETI remains within Acceptability Limits AL • Set AL = 0.5 • Original AL set at 0.3 by WG2, rejected by WG3 Problem of the initial AP method: • For standard deviation s > 0.12: false rejections increase quickly • For standard deviation s > 0.2: probability of false rejection 100 %