AOAC ERP Gluten Assays - Dec 2018

Annex B

1

Scope of Method

1.1

Target Analytes

All gluten fractions from wheat, rye and barley with the exception of D-hordein from barley; In detail these are: intact (non-hydrolyzed) gliadins and related prolamins from rye and barley, High-Molecular Weight (HMW) Glutenin-Subunits (GS) from wheat, HMW-secalins from rye and Low-Molecular-Weight (LMW)–GS from wheat.

1.2 Matrices

In course of this in-house validation, RIDASCREEN ® Total Gluten was tested with the following matrices: oat flour, flaked oats, oat cereals, groats, oat cookies, and oat porridge.

1.3

Summary of Validated Performance Claims

According to the manufacturer, the RIDASCREEN ® Total Gluten detects gluten at 1.9 mg/kg. No cross-reacting substance has been identified by the manufacturer. LoQ was proven to be at 5 mg/kg gluten. AOAC reference materials mentioned in SMPR ® 2017.021 (1) showed recoveries between 86% and 131% for wheat and barley, while rye showed higher recoveries between 137% and 170%. Recovery studies with incurred oat cookies and porridge revealed values between 55% and 122%. The precision of the whole procedure is mainly driven by inhomogeneity of samples. A ruggedness study revealed no significant parameters for the extraction or ELISA procedure. The test kit is stable for at least 3 weeks at 37°C.

Method/Report Authors Markus Lacorn and Thomas Weiss R-Biopharm AG An der neuen Bergstrasse 17 D-64297 Darmstadt, Germany

Submitting Company R-Biopharm AG

An der neuen Bergstraße 17 D-64297 Darmstadt, Germany

Independent Laboratory Not applicable (covered by collaborative study)

Reviewers To be determined

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