Are current analytical methods suitable to verify VITAL® 2.0/3.0 allergen reference doses for EU allergens in foods?

Holzhauser, Thomas; Johnson, Philip E.; Hindley, James P.; O’Connor, Gavin; Chan, Chun-Han; Costa, Joana; Fæste, Christiane Kruse; Hirst, Barbara J.; Lambertini, Francesca; Miani, Michela; Robert, Marie-Claude; Röder, Martin; Ronsmans, Stefan; Bugyi, Zsuzsanna; Tömösközi, Sándor; Flanagan, Simon

doi:10.1016/j.fct.2020.111709

Cited by 94 publications

(69 citation statements)

References 154 publications

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“…The ELISA was not evaluated for its sensitivity in detecting raw clam protein because clams are typically heat-processed in food formulations. The minimal eliciting or threshold dose for clam protein in clam-allergic individuals is not known but such threshold doses are known for several other allergenic foods and were related to analytical methods to quantify allergens in food [ 30 ]. Based on the mean dose for 10 food allergens needed to provoke an objective allergic reaction in the 1% most sensitive segment of the food-allergic population [ 30 ] and using a conservatively high consumption amount of 250 g of whole clam, the mean action level for analytical methods should be 7 ppm.…”

Section: Resultsmentioning

confidence: 99%

Development of a Sandwich Enzyme-Linked Immunosorbent Assay for Detection and Quantification of Clam Residues in Food Products

Koppelman

Lardizabal

Niemann

et al. 2021

BioMed Research International

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Seafood is a frequent cause of allergic reactions to food globally. The presence of undeclared trace amounts of clam can cause allergic reactions in sensitive individuals. Limited tools are available to test food products for the presence of traces of clam. We report on the development of a sandwich ELISA that can detect and quantify clam protein in food. Antisera against a mix of two commercially important clam species, Atlantic Surf (Spisula solidissima) and ocean quahog (Arctica islandica), were raised in rabbit and sheep. A sandwich ELISA was constructed with this antisera, and sensitivity and specificity were evaluated. Also, model food products spiked with clam protein were analyzed to assess the performance of the ELISA. Comparison was made with a commercially available ELISA for crustacea. The lower limit of quantification of the sandwich ELISA is 2.5 ppm clam protein in food samples, allowing the detection of low amounts of clam that may trigger a reaction in clam allergic patients. The sandwich ELISA was highly specific with cross-reactivity only noted for other molluscan shellfish (mussel and scallop). Clam protein in tomato juice and potato cream soup was detected well with recoveries ranging from 65 to 74% and from 74 to 113%, respectively. However when potato cream soup was retorted, the recover fell to 20%, imposing the risk of underestimating the clam content of a food product. A commercially available crustacean ELISA test was not suitable to detect clam protein. The sandwich ELISA described here is suitable for detection and quantification of clam protein in food products. Care should be taken with food products that have been retorted as the results may be underestimated.

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Section: Resultsmentioning

confidence: 99%

Development of a Sandwich Enzyme-Linked Immunosorbent Assay for Detection and Quantification of Clam Residues in Food Products

Koppelman

Lardizabal

Niemann

et al. 2021

BioMed Research International

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“…According to its well-known selectivity and sensitivity, MS have the power to overcome immunoassays (enzyme-linked immunosorbent assay, ELISA) and PCR-based techniques, the historically most adopted methods for allergens detection and quantitation. Specifically, although ELISA methods boost a general high sensitivity, they still encounter disadvantages such as cross-reactions with food matrix, limited reproducibility, variable specificity of antibodies in the commercial kits, lack of standard reference materials for some allergens and missing multiplexing detection ability [36].…”

Section: Discussionmentioning

confidence: 99%

Threshold of Reactivity and Tolerance to Precautionary Allergen-Labelled Biscuits of Baked Milk- And Egg-Allergic Children

Fierro¹,

Marzano²,

Monaci³

et al. 2021

Preprint

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Extremely sensitive food-allergic patients may react to very small amounts of allergenic foods. Precautionary allergen labelling (PAL) warns from possible allergenic contaminations. We explored the ability of proteomic methods to identify minute amounts of milk/egg allergens in a brand of PAL-labelled milk- and egg-free biscuits. We evaluated the reactivity of children with severe milk and egg allergy, by oral food challenge. Traces of milk and/or egg allergens in biscuits were measured by two different liquid-chromatography-mass spectrometry methods. The binding of patient's serum with egg/milk proteins was assessed at immunoblotting. None of the patients reacted to biscuits. Egg and milk proteins were found under the limit of detection of 0.6 µg/g for milk and egg (method A), and of 0.1 and 0.3 µg /g for milk and egg, respectively (method B). The immunoblots did not show milk/egg proteins in the studied biscuits. Our biscuits did not contain allergens of clinical significance. Their milk/egg content is far lower than 4 µg of milk or egg protein per gram of product, the minimal doses considered theoretically capable of causing reactions. With high sensitivity, proteomic assessments predict the harmlessness of very small amount of allergenic foods and can be used to avoid unnecessary PAL.

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“… 20 There are also few official analytical methods and limits of determination that are accepted as analytical reference in specific countries, such in the case of polymerase chain reaction (PCR) methods for allergen detection in Germany and Japan. 21 Overall, this poses a great risk for allergic people, as witnessed by the still observed reactions to food allergens, present even in countries with mandatory labeling. 22 …”

Section: International Requirements For Allergenic Ingredients Labellingmentioning

confidence: 99%

“…Other methods, such as ELISA and quantitative polymerase chain reaction (qPCR), while covering some of the above-mentioned limitations also carry method-specific issues, as illustrated by Holzhauser et al. 21 Efforts have been directed at the European level to overcome issues encountered in food allergen analysis. The establishment of reference doses and the necessity for sensitive and harmonized analytical methods along with the production of allergen Reference Materials have been the key objectives of the past Integrated Approaches to Food Allergen and Allergy Management (IFAAM) project, are part of the objectives of the International Association for Monitoring and Quality Assurance in the Total Food Supply Chain (MoniQA), and are part of the current European Food Safety Authority (EFSA) funded Detection and Quantification of Allergens in Food and Minimum Eliciting Doses in Food Allergic Individuals (ThRAll) project.…”

Section: The Proteomic Mass Spectrometry Based Approachmentioning

confidence: 99%

Food labeling issues for severe food allergic patients

Fiocchi

Risso²,

DunnGalvin

et al. 2021

World Allergy Organization Journal

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Food allergy carries high importance and responsibility, affecting an estimated 220 million people worldwide. It is a frequent cause of food-induced anaphylaxis, a life-threatening condition requiring a toll of about one death per 50 million people a year worldwide. In order to help patients to identify allergenic foods and thus avoid anaphylactic reactions, 66 countries over the 5 continents require by law that allergenic ingredients must be declared when used in prepackaged foods. Unfortunately, the mandatory allergen list is not uniform, but varies among different countries. The widespread adoption of Precautionary Allergen Labeling (PAL) results in a proliferation of unregulated PALs with different informative statements. In this situation, the need of a scientific consensus on the definition of food allergy and the identification of a tolerable risk with routinely used detection assays, considering not only the eliciting dose but also the food source, is urgent. The aim of this manuscript is: 1) to draw a picture of the global situation in terms of PALs, and 2) to highlight new approaches that could aid in tackling the problem of regulating the labeling of allergens. These include the Voluntary Incidental Trace Allergen Labelling (VITAL) system, which intersects reference doses and labelling decisions, and a direct quantification of trace amounts of allergens at lower limit of detection (LOD) levels in the food itself through proteomics. We here highlight how, although with some limitations, the steady advances in proteomic approaches possess higher sensitivity than the recommended VITAL reference doses, allowing the identification of allergens at much lower LOD levels than VITAL. Considering that each assay used to detect allergen in food products carries method-specific issues, a more comprehensive and harmonized approach implementing both quantitative and qualitative methods could help overcoming the risk stratification approach and the overuse of PALs, offering promise as the field moves forward towards improving consumers’ quality of life.

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Are current analytical methods suitable to verify VITAL® 2.0/3.0 allergen reference doses for EU allergens in foods?

Cited by 94 publications

References 154 publications

Development of a Sandwich Enzyme-Linked Immunosorbent Assay for Detection and Quantification of Clam Residues in Food Products

Development of a Sandwich Enzyme-Linked Immunosorbent Assay for Detection and Quantification of Clam Residues in Food Products

Threshold of Reactivity and Tolerance to Precautionary Allergen-Labelled Biscuits of Baked Milk- And Egg-Allergic Children

Food labeling issues for severe food allergic patients

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