AOAC Guidance on FA Immunoassay Validation (August 2023)

522 Figure 4: Design 2b. Lot: test kit lot, TP: test portion, E: ELISA measurement. Design 2b can be used to 523 estimate intermediate precision, repeatability, ELISA variance, and lot-to-lot product consistency.

524 525 526 527 528 529

5.2.4.2.3.9. If repeatability is conducted separately ( Figure 5 ), at least six test portions of each test material should be analyzed according to the entire method as written. Analysis should be conducted by one analyst on one day, using one

test kit lot (n=6 per test material).

530 531 532 533 534 535 536 537

Figure 5: Repeatability Only Design

5.2.4.2.4. Sensitivity: LOD/LOQ Estimation

5.2.4.2.4.1. In SLV studies for food allergen immunoassay methods, the LOD and LOQ will

be estimated using intermediate precision.

5.2.4.2.4.2. Data collected from analysis of incurred test materials for all matrices will be

used to model the relationship between analyte concentration and