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

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201

202 For instances where the standard method protocol only requires one ELISA well to be measured for each 203 test portion, the repeatability (s r ) is the square root of the sum of the test portion variance component 204 and the ELISA variance. 205 = + 206 = � 207 For the example dataset when analyst is nested within lot and test portion is nested within analyst: 208 = . + . 209 = √ . 210 = . 211 For instances where the standard method protocol requires the measurement of multiple replicate 212 ELISA wells (n) for each test portion, with the results averaged to give a single result, you will want to 213 use designs 2a or 2b, and the intermediate precision standard deviation (s i ) is the square root of the sum 214 of the lot variance component, the analyst variance component, the test portion variance component, 215 and the ELISA variance divided by the number of replicate wells. Do not average the replicate wells 216 before running the ANOVA: 217 = + + + 218 = � 219 For the example dataset when analyst is nested within lot and test portion is nested within analyst: 220 = . + . + . + . 221 = √ . 222 = . 223 For instances where the standard method protocol only requires one ELISA well to be measured for each 224 test portion (i.e., n=1), the intermediate precision standard deviation is equivalent to the square root of 225 the total variance component, reported as total SD in the ANOVA table. 226 227 For the example dataset when analyst is nested within lot and test portion is nested within analyst: 228 = . 229 230