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

Name

DF

SS

MS

VC

%Total

SD

CV[%]

1 total

3.182687 92.85136

100 9.635941 10.04162

2 Lot

2 1109.537 554.7684 66.82999 71.97524 8.174961 8.519134 1 207.8743 207.8743 15.64549 16.85003 3.955437 4.121965 8 161.0281 20.12851 9.752615 10.50347 3.122918 3.254395 12 7.479314 0.623276 0.623276 0.671262 0.789478 0.822716

3 Analyst

4 Lot:Analyst:TP

5 error

Mean:

95.96 (N=24)

183

Result ~ Lot/Analyst/TP

Analyst nested within Lot and TP Nested within Analyst

Name

DF

SS

MS

VC

%Total

SD

CV[%]

1 total

2.958485 85.02862

100 9.221097 9.609313

2 Lot

2 1109.537 554.7684 59.10844 69.51594 7.688202 8.011882

3 Lot:Analyst

3 245.7025 81.90085 15.34189

18.0432 3.916872 4.081776

4 Lot:Analyst:TP

6 123.1998 20.53331 9.955015 11.70784 3.155157 3.287992 12 7.479314 0.623276 0.623276 0.733019 0.789478 0.822716

5 error

Mean:

95.96 (N=24)

184 185 186

Use the same code for Design 2a.

Reporting Precision Estimates 187 Calculation procedures for repeatability standard deviation and intermediate precision from Designs 2a 188 and 2b depend on whether or not the standard method protocol requires measurement of multiple 189 ELISA wells for each test portion. 190 For instances where the standard method protocol requires the measurement of multiple replicate 191 ELISA wells (n) for each test portion, with the results averaged to give a single result, the repeatability 192 standard deviation (s r ) is the square root of the sum of the test portion variance component and the 193 ELISA variance divided by the number of replicate wells: 194 = + 195 = � 196 In the ANOVA table, the test portion variance component is given as the VC for Lot:Analyst:TP. The ELISA 197 variance component is given as the VC for the error row. 198 For the example dataset when analyst is nested within lot and test portion is nested within analyst: 199 = . + . 200