AOAC Gluten Qualitative Validation Guidance-FINAL (July 2023)
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AOAC GFA Program (Gluten)
1
Qualitative Validation Guidance Main
2
1. Scope
3
2. Applicability
3
3. Terms and Definitions
3
References
3
Definitions
4
3.1 Analyte
4
3.2 Candidate Method
4
3.3 Candidate Method Result
4
3.4 Claimed Detection Capability (CDC)
4
3.5 Collaborator
4
3.6 Cross-reactivity
4
3.8 Data Set
4
3.9 Fractional POD Range
4
3.10 Gluten
4
3.11 High-Dose Hook Effect
4
3.12 Incurred Test Material
4
3.13 Independent Testing Site
4
3.14 Interference Study
4
3.15 Lateral Flow Device (LFD)
4
3.16 LPOD
4
3.17 Matrix
4
3.18 Measurand
4
3.20 Method
5
3.21 Probability of Detection (POD)
5
3.22 Qualitative Binary Method
5
3.23 Repeatability
5
3.24 Reproducibility
5
3.25 Robustness Study
5
3.26 Selectivity
5
3.27 Spiked Test Material
5
3.28 Test Material
5
3.29 Test Portion
5
3.30 Test Sites
5
4. Method Validation
6
4.1 Method Developer Validation Study
6
4.1.1 Scope
6
4.1.2 Selectivity study
6
4.1.3 Matrix / POD study
7
4.1.4 Data analysis and reporting for selectivity and matrix / POD studies
8
4.1.5 Intended use statement
8
4.1.6 Robustness study
8
4.1.7 High-Dose Hook Effect Study
8
4.1.8 Method Instructions
8
4.1.9 Product consistency and stability study
9
4.2 Independent Lab Validation Study
9
4.2.1 Scope
9
4.2.2 Matrix Study
9
4.2.3 Data Analysis and Reporting
10
4.3 Collaborative Study
10
4.3.1 Scope
10
4.3.2 Number of Collaborators
10
4.3.3 Matrix / POD study
10
4.3.4 Data analysis and reporting
10
4.3.5 Collaborator comments
10
4.4 Matrix Extension
11
4.4.1 Matrix Extension for single lab validation studies
11
4.4.2 Matrix Extension for multi-site collaborative studies
11
ANNEX A - Inclusivity-Exclusivity Panel (Selectivity Study)
12
ANNEX B - Test Material Preparation
14
ANNEX C - Matrix Categories
19
ANNEX D - Robustness Study Design and Analysis
23
COMMENTS & RESPONSES
31
Working Group Document Comments with Responses (Round 1)
31
Working Group Document Comments with Responses (Round 2)
53
Public Comments with Responses (FINAL)
57
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