AOAC-RI ERP Book - Gluten.pdf

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Method Author Contact
Information:
PART V - METHOD INFORMATION
Legal Name of
Method/Product:
Catalog Number(s) - (if
applicable)
PTM Certification/OMA # (if
applicable)
Original Validated Method
Applicability and Intended
Use
INDICATE THE TYPE OF
PROPOSED MODIFICATION
OR EXTENSION
Summarize the Proposed
Modification or Extension
Summarize How the
Proposed Modification will be
Evaluated.
Dr. Markus Lacorn
R&D Validation & Study Management
R-Biopharm AG
Postanschrift: An der neuen Bergstraße 17, 64297 Darmstadt
Telefon: 0 61 51 - 81 02 - 464
Fax: 0 61 51 - 81 02 - 40
E-Mail:
AOAC Official Method 2012.01
Gliadin as a Measure of Gluten in Foods Containing Wheat, Rye, and Barley
R7001
2012.01
See attached.
Method/Reagent Stability
The AOAC validated ELISA assays RIDASCREEN® Gliadin R7001 (OMA first action
2012.01) using a washing buffer which contains thimerosal (also known as thiomersal),
a mercury containing preserving agent. Since the use and/or the disposal of mercury-
containing liquids is heavily regulated in many countries or even prohibited in some
countries and also in order to protect the environment, R-Biopharm AG would like to
substitute thimerosal in the washing buffer by the mercury-free preserving agent
bronidox L. This preserving agent has also been used at R-Biopharm AG for many
years in more than a dozen ELISA for clinical analysis without any problems. However,
an accelerated stability and functional testing as well as a microbial testing have been
performed at R-Biopharm AG for the four concerned allergen and gluten ELISA.
In order to assess whether the use of bronidox L instead of the hitherto preserving
agent thimerosal secures the stability of the washing buffer, an accelerated stability
testing has been performed. That included stability testing of the 10fold concentrate as
provided in the test kit as well as of the finally diluted washing buffer. The accelerated
stability testing used a storage temperature of 37°C. Additionally, two to three control
samples were used to assess whether the usage of bronidox L instead of thimerosal
has an impact on the measured concentrations of these samples (functional testing).