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J Agric Food Chem. 2016 May 11;64(18):3678-87. doi: 10.1021/acs.jafc.5b06085. Epub 2016 Apr 27.

Novel Monoclonal Antibody-Based Immunodiagnostic Assay for Rapid Detection of Deamidated Gluten Residues.

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Molecular Epidemiology, Inc. (MEI) , 15300 Bothell Way N.E., Lake Forest Park, Washington 98155, United States.
IEH Laboratories and Consulting Group, Inc. (IEH) , 15300 Bothell Way N.E., Lake Forest Park, Washington 98155, United States.
Pi Bioscientific, Inc. (Pi Bio) , 8315 Lake City Way N.E., Seattle, Washington 98115, United States.


Gluten derived from wheat and related Triticeae can induce gluten sensitivity as well as celiac disease. Consequently, gluten content in foods labeled "gluten-free" is regulated. Determination of potential contamination in such foods is achieved using immunoassays based on monoclonal antibodies (mAbs) that recognize specific epitopes present in gluten. However, food-processing measures can affect epitope recognition. In particular, preparation of wheat protein isolate through deamidation of glutamine residues significantly limits the ability of commercial gluten testing kits in their ability to recognize gluten. Adding to this concern, evidence suggests that deamidated gluten imparts more pathogenic potential in celiac disease than native gluten. To address the heightened need for antibody-based tools that can recognize deamidated gluten, we have generated a novel mAb, 2B9, and subsequently developed it as a rapid lateral flow immunoassay. Herein, we report the ability of the 2B9-based lateral flow device (LFD) to detect gluten from wheat, barley, and rye and deamidated gluten down to 2 ppm in food as well as its performance in food testing.


LFD; celiac disease; deamidation; gliadin; gluten; mAb; prolamins; wheat protein isolate

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