AOAC Guidance on FA Immunoassay Validation (August 2023)

1.5.4. Data Output

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Analyst not nested within Lot

Result ~ (Lot+Analyst)

Name

DF

SS

MS

VC

%Total

SD

CV[%]

1 total

2.68720 95.9797

100 9.79692 9.19518

2 Lot

1 255.407 255.407 39.2024 40.8444 6.26118 5.87661 1 239.698 239.698 36.5841 38.1165 6.04848 5.67697 9 181.739 20.1933 20.1933 21.0391 4.49369 4.21768

3 Analyst

4 error

Mean: 106.5441

(N = 12)

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DF: Degrees of freedom SS: Sums of squares MS: Mean square error VC: Variance component

%Total: Percent of total variance contributed by factor

SD: Standard deviation

Result ~ Lot/Analyst

Analyst nested within Lot

Name

DF

SS

MS

VC

%Total

SD

CV[%]

1 total

2.955354 77.6877

100 8.81406 8.27269

2 Lot

1 255.408 2 241.164 8 180.273

255.408 22.4709 28.9247 4.74035 4.44919 120.582 32.6826 42.0693 5.71687 5.36574

3 Lot:Analyst

4 error

22.5341

22.534 29.0060 4.74701 4.45544

Mean :

106.5441 (N=12)

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1512

1.5.4.1.

Use the same code for Design 1b

1.5.5. Reporting of Precision Estimates

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For Designs 1a and 1b, the repeatability standard deviation (s r ) is equivalent to the square root of the test portion variance component, reported as error SD in the In the example dataset where analyst is nested within lot, s r = 4.75 For Designs 1a and 1b, the intermediate precision standard deviation (s i ) is equivalent to the square root of the total variance component, reported as total SD ANOVA table.

1.5.5.1.

1.5.5.2. 1.5.5.3.

in the ANOVA table.

1.5.5.4.

In the example dataset where analyst is nested within lot, s i = 8.81