AOAC Gluten Quantitative Validation Guidance-Round 1(Nov 2023)
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AOAC GFA Program (Gluten)
1
Quantitative Gluten Guidance (Round 1)
2
1. Scope
3
2. Applicability
3
3. Terms and Definitions
3
References
3
Definitions
4
3.1 Analyte:
4
3.2 Bias:
4
3.3 Calibrant:
4
3.4 Candidate Method:
4
3.5 Candidate Method Result:
4
3.6 Collaborator:
4
3.7 Cross-reactivity:
4
3.8 Cross-reactivity Study:
4
3.15 Intermediate precision conditions:
5
3.29 Repeatability Conditions:
6
3.31 Reproducibility Conditions:
6
4. Method Developer Validation Study
7
4.1 Scope
7
4.2 Calibration Fit Study
7
4.3 Selectivity Study
7
4.4 Matrix Study
8
LOD/LOQ Estimation
11
Recovery Assessment
11
4.5 Data Analysis and Reporting for Matrix Studies
11
Nested Designs: Repeatability and Intermediate Precision
11
Repeatability Only
11
LOD, LOQ
11
Recovery
12
4.6 Acceptance Criteria for Matrix Studies
12
LOQ
12
4.7 Robustness Study
12
Product Stability and Consistency
13
4.8 Method Instructions and Required Method Information
13
5. Independent Laboratory Study
14
5.1 Scope
14
5.2 Matrix Study
14
6. Collaborative (Interlaboratory) Study
14
6.1 Scope:
14
6.2 Number of Laboratories:
15
6.3 Matrix Study
15
6.4 Test Materials:
15
6.5 Data Analysis
15
6.6 Acceptance Criteria
16
LOQ
16
6.7 Collaborator Comments
16
7. Matrix Extension
16
7.1 Matrix Extension for single lab validation studies
16
7.2 Matrix Extension for multi-site collaborative studies
16
ANNEX A - Inclusivity-Exclusivity Panel
19
ANNEX B - Test Material Preparation
22
ANNEX C - Matrix Categories
26
ANNEX D - Statistical Methods
34
Working Group Comments Round 1 - RESOLVED
56
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