Standard Method Performance Requirements (SMPRs®) 2017.021: Quantitation of Wheat, Rye, and Barley Gluten in Oats

Boison, Joe O.; Allred, Laura K; Almy, David; Anderson, L. E.; Baumert, Joseph L.; Bhandari, Sneh; Cebolla, Ángel; Chen, Yumin; Crowley, Erin; Diaz‐Amigo, Carmen; Doi, Hidetaka; Don, Clyde; Downs, Melanie L.; Dubiel, Nyla; Dyer, Benjamin; Emerson, Luke; Farrow, Michael; Fritz, Ron; Galera, Carlos; Garber, Eric A. E.; Godefroy, Samuel Benrejeb; Grace, Thomas; Hochegger, Rupert; Johnson, Kurt; Kasturi, Prabhakar; Koerner, Terry; Lacorn, Markus; Massong, Frank; Meinhardt, Patti; Mui, Tracy; O'Meara, Mary; Pan, Shang-Jing; Pöpping, Bert; Prinster, Michael; Quesada, Elena; Radcliffe, Scott; Scherf, Katharina Anne; Sharma, Girdhari M.; Shoji, Masahiro; Stoughton, Melonie; Sweeney, Lynne; Szpylka, John; Taylor, Stephen L; Tittlemier, Sheryl A.; Torgler, Catherine; Wehling, Paul; Yeung, Jupiter M.; Zweigenbaum, Jerry

doi:10.5740/jaoacint.smpr2017.021

Cited by 8 publications

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“…Because of these limitations to the R5 method, a group of oat processors and test kit manufacturers founded an initiative through AOAC INTERNATIONAL in 2016. The resulting Standard Method Performance Requirement (SMPR ® ) 2017.021 was adopted by stakeholders in 2017 (22). The method acceptance criteria given in the SMPR are that mean recoveries for gluten from wheat, rye, and barley in oats and oat products must be between 50 and 200%.…”

mentioning

confidence: 99%

Quantification of Wheat, Rye, and Barley Gluten in Oat and Oat Products by ELISA RIDASCREEN® Total Gluten: Collaborative Study, First Action 2018.15

et al. 2019

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demonstrated performance on oat matrices, which meets the criteria as specified in SMPR 2017.021. Data from in-house validation experiments are available as Annex B to this publication. W ith a prevalence of 0.4-1.2% of the population in Europe, North America, Australia, and the Middle East (1), celiac disease (CD) is considered to be one of the most common food hypersensitivities. CD is an immunemediated inflammatory disease of the upper small intestine in genetically predisposed individuals triggered by the ingestion of dietary gluten (2). In the context of CD, gluten is defined as a protein fraction from wheat, rye, barley, or their crossbred varieties and derivatives thereof, to which some persons are intolerant, and is insoluble in water and 0.5 mol/L NaCl (3). Gluten is composed of prolamins that can be extracted by 40-70% ethanol and alcohol-insoluble glutelins that can only be extracted under reducing and disaggregating conditions at elevated temperatures. The prolamins from wheat, rye, and barley are called gliadins, secalins, and hordeins, respectively, and the prolamin content of gluten is generally taken as 50% (3). The only known effective treatment for CD is a lifelong gluten-free diet, which is based on the avoidance of gluten-containing cereals and should contain less than 20 mg gluten per day to prevent a relapse of intestinal damage (4). To guarantee the safety of gluten-free products for CD patients, a threshold of 20 mg/kg gluten for gluten-free foods is recommended by the Codex Alimentarius and legislation, for example, by the Department of Health and Human Services Food and Drug Administration in the United States (5) and by the European Commission in Europe (6). Specific and sensitive analytical methods are therefore needed for food QC. Immunochemical methods are currently recommended for the quantitative and qualitative determination of gluten in foods (3). Sandwich and competitive ELISA formats (RIDASCREEN ® Gliadin R-Biopharm R7001 and RIDASCREEN Gliadin competitive R-Biopharm R7021) based on the R5 monoclonal antibody (7) were successfully validated as AACCI Approved Method 38-50.01 for intact gluten (8) and 38-55.

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confidence: 99%

Quantification of Wheat, Rye, and Barley Gluten in Oat and Oat Products by ELISA RIDASCREEN® Total Gluten: Collaborative Study, First Action 2018.15

et al. 2019

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“…The performance of the test kit was recently validated for the quantitative analysis of wheat, rye and barley gluten in oat and oat products by an international collaborative study with 19 laboratories. The results of the study showed recoveries ranging from 99 to 137% for wheat, rye and barley when analyzing defined validation materials (159,160) and relative reproducibility standard deviations from 10 to 53% for samples containing 10 mg/kg of gluten or higher. Following review by the AOAC Expert Review Panel for Gluten Assays, the method was adopted as AOAC Official Method First Action 2018.15 (21).…”

Section: Advances In Compliance Monitoring Of Gluten-free Productsmentioning

confidence: 94%

Recent Progress and Recommendations on Celiac Disease From the Working Group on Prolamin Analysis and Toxicity

et al. 2020

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Celiac disease (CD) affects a growing number of individuals worldwide. To elucidate the causes for this increase, future multidisciplinary collaboration is key to understanding the interactions between immunoreactive components in gluten-containing cereals and the human gastrointestinal tract and immune system and to devise strategies for CD prevention and treatment beyond the gluten-free diet. During the last meetings, the Working Group on Prolamin Analysis and Toxicity (Prolamin Working Group, PWG) discussed recent progress in the field together with key stakeholders from celiac disease societies, academia, industry and regulatory bodies. Based on the current state of knowledge, this perspective from the PWG members provides recommendations regarding clinical, analytical and legal aspects of CD. The selected key topics that require future multidisciplinary collaborative efforts in the clinical field are to collect robust data on the increasing prevalence of CD, to evaluate what is special about gluten-specific T cells, to study their kinetics and transcriptomics and to put some attention to the identification of the environmental agents that facilitate the breaking of tolerance to gluten. In the field of gluten analysis, the key topics are the precise assessment of gluten immunoreactive components in wheat, rye and barley to understand how these are affected by genetic and environmental factors, the comparison of different methods for compliance monitoring of gluten-free products and the development of improved reference materials for gluten analysis.

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“…However, recognition and measurement of gluten contamination in oat products with ELISA kits are still a problem. At AOAC (Association of Official Analytical Collaboration) International, a stakeholder panel convened and agreed upon standard requirements for the quantitation of total wheat, rye, and barley gluten in oat products by ELISA [ 41 ]. The defined method acceptance criteria were 5–15 mg/kg of gluten as the analytical range, limits of detection and quantitation below 5 mg/kg of gluten, and 50–200% recovery.…”

Section: Gluten Contamination In Gluten-free Foodsmentioning

confidence: 99%

Food Safety and Cross-Contamination of Gluten-Free Products: A Narrative Review

Wieser¹,

Segura

Ruiz-Carnicer

et al. 2021

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A gluten-free diet (GFD) is currently the only effective treatment for celiac disease (CD); an individual’s daily intake of gluten should not exceed 10 mg. However, it is difficult to maintain a strict oral diet for life and at least one-third of patients with CD are exposed to gluten, despite their best efforts at dietary modifications. It has been demonstrated that both natural and certified gluten-free foods can be heavily contaminated with gluten well above the commonly accepted threshold of 20 mg/kg. Moreover, meals from food services such as restaurants, workplaces, and schools remain a significant risk for inadvertent gluten exposure. Other possible sources of gluten are non-certified oat products, numerous composite foods, medications, and cosmetics that unexpectedly contain “hidden” vital gluten, a proteinaceous by-product of wheat starch production. A number of immunochemical assays are commercially available worldwide to detect gluten. Each method has specific features, such as format, sample extraction buffers, extraction time and temperature, characteristics of the antibodies, recognition epitope, and the reference material used for calibration. Due to these differences and a lack of official reference material, the results of gluten quantitation may deviate systematically. In conclusion, incorrect gluten quantitation, improper product labeling, and poor consumer awareness, which results in the inadvertent intake of relatively high amounts of gluten, can be factors that compromise the health of patients with CD.

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Standard Method Performance Requirements (SMPRs®) 2017.021: Quantitation of Wheat, Rye, and Barley Gluten in Oats

Cited by 8 publications

References 0 publications

Quantification of Wheat, Rye, and Barley Gluten in Oat and Oat Products by ELISA RIDASCREEN® Total Gluten: Collaborative Study, First Action 2018.15

Quantification of Wheat, Rye, and Barley Gluten in Oat and Oat Products by ELISA RIDASCREEN® Total Gluten: Collaborative Study, First Action 2018.15

Recent Progress and Recommendations on Celiac Disease From the Working Group on Prolamin Analysis and Toxicity

Food Safety and Cross-Contamination of Gluten-Free Products: A Narrative Review

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