Normalisation of data from allergens proficiency tests

Sykes, Mark; Anderson, Dominic; Parmar, Bhavna

doi:10.1007/s00216-012-5780-6

Cited by 9 publications

(11 citation statements)

References 12 publications

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“…Judging by the available literature (Allred and Ritter 2010;Bruins Slot et al 2015a;Bugyi et al 2013;Rallabhandi et al 2015;Sharma et al 2015), these results were not unexpected, mostly because of the different characteristics of the ELISA test kits (Table 1) that cause systematic deviations (Sykes et al 2012). As the first step, the gluten extraction procedure has an important influence on the analytical results.…”

Section: Discussionmentioning

confidence: 91%

Gluten Analysis of Wheat Starches with Seven Commercial ELISA Test Kits—Up to Six Different Values

Scherf

2016

Food Anal. Methods

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The use of purified wheat starch (WSt) as part of the gluten-free diet for celiac disease (CD) patients is considered safe in many countries, but uncertainties about residual gluten amounts remain. Enzyme-linked immunosorbent assays (ELISAs) are most commonly used to monitor compliance to the Codex threshold of 20 mg gluten/kg of the product, but the analytical results for one sample may differ depending on the characteristics of the test kit. This study aimed to compare a representative collection of ELISAs regarding their ability to quantitate gluten contents of WSt. The gluten contents of 30 WSt (14 declared as gluten-free) and one defined assay control were analyzed with seven commercial ELISA test kits using the respective recommended extraction protocol for WSt samples. The comparative analysis of gluten yielded up to six significantly different results per WSt. In 13 samples, at least one kit found gluten contents below 20 mg/kg and at least two kits found gluten contents above 20 mg/kg, which would affect accurate labeling of the WSt depending on the kit used. The results of different kits were only partly correlated to one another. The different specificities and sensitivities of the various test systems were most apparent at levels between the regulatory threshold of 20 mg gluten/kg and the respective limits of quantitation. To ensure the safety of gluten-free products for CD patients, it is important to know which test kit is best suited to reliably detect gluten traces in a variety of food matrices.

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Section: Discussionmentioning

confidence: 91%

Gluten Analysis of Wheat Starches with Seven Commercial ELISA Test Kits—Up to Six Different Values

Scherf

2016

Food Anal. Methods

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“…It was shown that a standardised calibrant (e.g. a matrix-matched standard) can be successfully used to normalise the data set from different allergen ELISA kits (Sykes et al, 2012). More recently, a dessert matrix incurred with pasteurised egg white or skimmed milk powder was produced and evaluated in a multilaboratory trial as a promising quality control material for food allergen analysis (Johnson et al, 2014).…”

Section: Enzyme-linked Immunosorbent Assaymentioning

confidence: 99%

Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes

Products¹

2014

EFS2

115

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Following a request from the Food Safety Authority of Ireland, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) was asked to deliver a scientific opinion on the evaluation of allergenic foods and food ingredients for labelling purposes. In view of the request, the NDA Panel decided to update its previous opinions relative to food ingredients or substances with known allergenic potential listed in Annex IIIa of 2003/89/EC, as amended. These include cereals containing gluten, milk and dairy products, eggs, nuts, peanuts, soy, fish, crustaceans, molluscs, celery, lupin, sesame, mustard and sulphites. The opinion relates to immunoglobulin (Ig)E-and non-IgE-mediated food allergy, to coeliac disease and to adverse reactions to sulphites in food, and it does not address non-immune-mediated adverse reactions to food. It includes information on the prevalence of food allergy in unselected populations, proteins identified as food allergens, cross-reactivities, the effects of food processing on the allergenicity of foods and ingredients, methods for the detection of allergens and allergenic foods, doses observed to trigger adverse reactions in sensitive individuals and risk assessment methodologies that have been used to derive individual and population thresholds for selected allergenic foods. The present opinion relates to immunoglobulin (Ig)E-and non-IgE-mediated food allergy, to coeliac disease and to adverse reactions to sulphites in food, and it does not address non-immune-mediated adverse reactions to food. For each food ingredient or substance listed in Annex IIIa, it includes information on the prevalence of food allergy in unselected populations, on proteins identified as food allergens, on cross-reactivities, on the effects of food processing on the allergenicity of foods and ingredients, on methods for the detection of allergens and allergenic foods, and on doses observed to trigger adverse reactions in sensitive individuals.Immune-mediated adverse reactions to foods manifest with clinical signs and symptoms of variable severity and duration, which may affect different organs and systems. Anaphylactic reactions to food are IgE mediated and may occur at any age. Non-IgE-mediated food allergy includes a wide range of diseases, including protein-induced enterocolitis and eosinophilic oesophagitis.A careful family and clinical history are the basis for diagnosis of food allergy. Food diaries, skin prick tests (SPTs), allergen-specific IgE measurements, food elimination diets and food challenges are part of the standard protocol for the diagnosis of food allergy. A positive SPT indicates sensitisation to the tested food, but it is not diagnostic of food allergy. Allergen-specific serum IgE antibodies similarly denote sensitisation to a particular food, but they are not diagnostic without a clinical history or food challenge. The use of atopy patch tests for the diagnosis of food allergy is controversial. Other available tests have no current role in the diagnosis of food allergy. Diag...

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“…43 In proficiency testing multimodal datasets for allergen ELISAs are common and different assigned values have to be generated for the different kits used. 44 Recent work on precautionary labelling on pre-packed processed food and concentrations of certain cross contaminant allergens in foods suffered from unexpected cross reactivity in the commercial ELISA. False positive results were identified arising from an Association of Analytical Communities (AOAC) approved peanut assay owing to cross reactivity to soya.…”

Section: Allergen Analysismentioning

confidence: 99%

“…Sykes et al 44 showed that inclusion of a 'reference spiked sample' in a Proficiency Test, PT, round where the raw data were non-normal and multi-modal, tended to yield ratio data that were normal and symmetrically distributed. These authors, and (non-exhaustively) many others [51][52][53][54] call for the development of internationally recognised sets of allergen reference materials to improve the reliability of allergen analysis.…”

Section: Reference Materialsmentioning

confidence: 99%

Is food allergen analysis flawed? Health and supply chain risks and a proposed framework to address urgent analytical needs

Walker¹,

Burns

Elliott

et al. 2016

Analyst

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Food allergy is an increasing problem for those affected, their families or carers, the food industry and for regulators. The food supply chain is highly vulnerable to fraud involving food allergens, risking fatalities and severe reputational damage to the food industry. Many facets are being pursued to ameliorate the difficulties including better food labelling and the concept of thresholds of elicitation of allergy symptoms as risk management tools. These efforts depend to a high degree on the ability reliably to detect and quantify food allergens; yet all current analytical approaches exhibit severe deficiencies that jeopardise accurate results being produced particularly in terms of the risks of false positive and false negative reporting. If we fail to realise the promise of current risk assessment and risk management of food allergens through lack of the ability to measure food allergens reproducibly and with traceability to an international unit of measurement, the analytical community will have failed a significant societal challenge. Three distinct but interrelated areas of analytical work are urgently needed to address the substantial gaps identified: (a) a coordinated international programme for the production of properly characterised clinically relevant reference materials and calibrants for food allergen analysis; (b) an international programme to widen the scope of proteomics and genomics bioinformatics for the genera containing the major allergens to address problems in ELISA, MS and DNA methods; (c) the initiation of a coordinated international programme leading to reference methods for allergen proteins that provide results traceable to the SI. This article describes in more detail food allergy, the risks of inapplicable or flawed allergen analyses with examples and a proposed framework, including clinically relevant incurred allergen concentrations, to address the currently unmet and urgently required analytical requirements. Support for the above recommendations from food authorities, business organisations and National Measurement Institutes is important; however transparent international coordination is essential. Thus our recommendations are primarily addressed to the European Commission, the Health and Food Safety Directorate, DG Santé. A global multidisciplinary consortium is required to provide a curated suite of data including genomic and proteomic data on key allergenic food sources, made publically available on line.

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Normalisation of data from allergens proficiency tests

Cited by 9 publications

References 12 publications

Gluten Analysis of Wheat Starches with Seven Commercial ELISA Test Kits—Up to Six Different Values

Gluten Analysis of Wheat Starches with Seven Commercial ELISA Test Kits—Up to Six Different Values

Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes

Is food allergen analysis flawed? Health and supply chain risks and a proposed framework to address urgent analytical needs

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