AOAC Guidance on FA Immunoassay Validation (August 2023)

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1.5.10.2.1.

In the ANOVA table, the test portion variance component is given as the VC for Lot:Analyst:TP. The ELISA variance component is given as the VC for the

error row.

1.5.10.2.2.

For the example dataset when analyst is nested within lot and test

= . + . = √ . = .

portion is nested within analyst:

1561

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1.5.10.3.

For instances where the standard method protocol only requires one ELISA well to be measured for each test portion, the repeatability (s r ) is the square root of the sum of the test portion variance component and the ELISA variance.

= + = �

1567

1568

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1.5.10.3.1.

For the example dataset when analyst is nested within lot and test

= . + . = √ . = .

portion is nested within analyst:

1.5.10.4.

For instances where the standard method protocol requires the measurement of multiple replicate ELISA wells (n) for each test portion, with the results averaged to give a single result, the intermediate precision standard deviation (s i ) is the square root of the sum of the lot variance component, the analyst variance component, the test portion variance component, and the ELISA variance divided by the number of

= + + + = . + . + . + . = �

replicate wells:

1580

1581

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1.5.10.4.1.

For the example dataset when analyst is nested within lot and test

portion is nested within analyst:

1584

= √ . = .

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