OMAMAN-47-ERPGlutenAssays-MeetingBook

ERP for Gluten Assays

3

Annex B

RIDASCREEN ® Total Gluten

In-house validation report for AOAC OMA First Action

Contents

Abstract

2

1

Scope of Method

1.1

Target Analyte

3

1.2

Matrices

3

1.3

Summary of Validated Performance Claims

3

2

Introduction

2.1

Principle

4

2.2

General Information

4

2.3

Summary of Results

4

3

Materials and Methods

3.1

Test Kit Information

5

3.2

Additional Supplies and Reagents

5

3.3

Apparatus

6

3.4

Standard Reference Material

6

3.5

Standard Solution and Spike Solution

6

3.6

General Preparation

6

3.7

Preparation of Components

7

3.8

Sample Preparation

7

3.9

Analysis

8

3.10 Reading

9

3.11 Calculation

9

3.12 Criteria for Acceptance of Standard Curve

9

4

Summary of Results

4.1

Manufacturer’s In-house Study

10

4.2

Independent Validation studies

32

5

Conclusion

32

6

References

32

7

Acknowledgements

33

Page 1 of 33

RIDASCREEN ® Total Gluten In-house validation report 2018-10-21

December 6, 2018