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

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3.29 Repeatability Conditions:

178 laboratory by the same operator using the same equipment within short intervals of time. 179 3.30 Reproducibility: 180 Precision under reproducibility conditions (ISO 5725-1). 181 3.31 Reproducibility Conditions: 182

Conditions where independent test results are obtained with the same method on equivalent test items in the same

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Conditions where independent test results are obtained with the same methods on equivalent test items in different

laboratories with different operators using separate instruments.

3.32 Robustness:

Measure of the capacity of an analytical procedure to remain unaffected by small variations in method parameters; provides

an indication of the method’s reliability during normal usage.

3.33 Selectivity:

The degree to which the method can quantify the target analyte in the presence of other analytes, matrices, or other

potentially interfering materials. Includes:

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Breadth: The ability of the method to detect gluten from multiple grain sources.

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Cross-reactivity: See definition of cross-reactivity above.

Measurement Interference: A cause of significant bias in the measured analyte concentration due to the effect of another 193 component or property of the sample which may result from non-specificity of the detection system, suppression of an indicator 194 reaction, or inhibition of the analyte (CLSI_EP07A2E). An interference can be endogenous, present in the test material, or 195 exogenous, introduced into the test material during the measurement process. 196 3.34 Spiked Test Material: 197 A food matrix into which gluten has been incorporated after all relevant food processing operations have been completed 198 (See Annex A for details). 199 3.35 Test material: 200 A material used for method validation that either contains a gluten source present at a given concentration in the context 201 of a food or environmental matrix or is a blank matrix free of gluten. 202 3.36 Test portion: 203 Portion of the test sample as prepared for testing or analysis, where the whole quantity is used for analyte extraction at one 204 time. (ISO 16577:2022)

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