AOAC Gluten Quantitative Validation Guidance-Round 1(Nov 2023)

Figure 8: Design 2a. Lot: test kit lot, TP: test portion, E: ELISA measurement. Design 2a can be used to estimate intermediate precision, repeatability, and ELISA variance.

Figure 9: Design 2b. Lot: test kit lot, TP: test portion, E: ELISA measurement. Design 2b can be used to estimate intermediate precision, repeatability, ELISA variance, and lot-to-lot product consistency.

Figure 10: Repeatability Only Design