AOAC Guidance on FA Immunoassay Validation (August 2023)

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Figure 1: Design 1a. Lot: test kit lot, TP: test portion, E: ELISA measurement. Design 1a can be

used to estimate intermediate precision and repeatability.

5.2.4.2.3.6. Design 1b

5.2.4.2.3.6.1. Design 1b ( Figure 2 ) can be used to estimate (1) intermediate precision (which includes repeatability, test kit lot variance (with 2 df), and day/operator confounded variance), (2) repeatability, and (3) lot-to-lot 5.2.4.2.3.6.2. Three test kit lots are used to analyze each test material. Two operators conduct analysis on two days for each test kit lot. For each day and lot, the assigned operator conducts extraction and analysis of two test portions of the test material, with one ELISA measurement performed per product consistency.

test portion.

488 Figure 2: Design 1b . Lot: test kit lot, TP: test portion, E: ELISA measurement. Design 1b can be used to 489 estimate intermediate precision, repeatability, and lot-to-lot product consistency. 490