Martin D. Chapman and Ross Yarham, both from Indoor Biotechnologies, shed light on Multiplex Array Technology for risk assessment in the food industry
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The prevalence of food allergy in the western world is rising, with some estimates approaching 10% of the population. According to the U.S. Centre for Disease Control and Prevention (CDC), it is estimated that more than 50 million adults in the United States have some form of allergy, with 6.5% of children under 18 years and up to 10.8% of adults having a food allergy. The most common food allergies amongst those affected in the U.S. are peanut, milk, shellfish, tree nut, eggs, and fish. Reported prevalence rates can vary greatly depending on the study design, with some potentially over or underestimating the true prevalence.
The globalisation of the food supply chain increases exposure to potential food allergens. There is a crucial need for robust controls to ensure that food allergens are correctly declared when intentionally present; monitored for and communicated to consumers when not intentionally, but possibly present; and strictly controlled to confirm absence when such claims as ‘free-from’ are made.
To protect those with food allergies and other food hypersensitivities, the FDA enforces the Food Allergen Labelling and Consumer Protection Act (FALCPA) which covers eight major food allergens, with sesame to be added as the 9th as of January 2023 as part of the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021. The FALCPA requires that the label of a food that contains an ingredient that is or contains protein from a “major food allergen” declare the presence of the allergen in one of two ways, either in parenthesis following the common or usual name of the major food allergen in the list of ingredients or declared in a separate ‘contains’ statement.
Allergen risk assessment is an essential component of food safety control for food businesses. There is a shift towards quantitative approaches to be used, particularly with the recent recommendations for reference doses for use in quantitative risk assessment (QRA) from the Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. A key component of any QRA is being able to determine the concentration of allergenic protein in a product. This requires robust analytical methods and tools that utilise relevant targets and provide meaningful results.
The FAO/WHO committee observed that reference doses can be implemented and monitored to some degree with current analytical capabilities, but acknowledged that significant limitations in method performance exist. The limitations of current test methods include irrelevant or unclear targets; inconsistent and ambiguous reporting units; and inefficient extraction methods, relevant to the food matrix in question. Current immunoassays which measure the concentration of food proteins using polyclonal antibodies, can lack the ability to distinguish between proteins that are known to cause allergic reactions. Other key limitations for the industry also include the relatively high costs of testing and the need, and indeed cost, for utilising multiple assays if there is more than one allergen in question. Indoor Biotechnologies molecular approach to food allergy offers a range of tools for the food industry and analytical community, specifically the use of multiplex array technology to measure multiple food allergens at once.
Indoor Biotechnologies has developed a suite of immunoassays for specific allergenic food protein molecules – the ‘active ingredients’ that are responsible for allergic reactions to foods. The multiplex array simultaneously measures up to 17 clinically relevant food allergens from a single sample. The test, called MARIA® for Foods, measures specific food allergen proteins and can be applied to industry risk assessments. MARIA® for Foods combines the power of Indoor Biotechnologies’ proprietary allergen-specific monoclonal antibodies with Luminex xMAP® technology and is calibrated using purified allergen standards, providing improved assay performance (increased sensitivity, accuracy and precision) over traditional techniques. MARIA® for Foods is a powerful and customisable platform, allowing the industry to choose which allergens are relevant to their application and run them together in one test on the same sample. This offers substantial time and cost savings.
MARIA® for Foods can be utilised by the food industry to measure all allergens that are regulated in the U.S., in the European Union, in Japan and other countries. This technology has multiple applications, dependant on the situation and the stage in the supply chain of a food product or indeed in new product development. Utilising its unique multiplex capability, the screening of allergen content of raw ingredients from suppliers can be performed to verify content claims and to complement a robust audit approach. MARIA® for Foods can quantify allergen content in final products and provide confirmation of allergen status. This is of particular importance for food making allergen ‘free-from’ claims and is where MARIA® for Foods’ increased assay performance provides the greatest benefit.
The use of MARIA® for Foods is not limited to testing food samples. Validation and monitoring of cleaning controls in manufacturing settings are extremely important to ensure there is no cross-contamination between food products on shared or adjacent lines, utensils and other equipment that come into contact throughout the supply chain. These controls can be assessed for efficacy by collecting and analysing different types of samples, for example, from rinse waters, swabs or wipe samples. MARIA® for Foods can analyse a range of different sample types. Indoor Biotechnologies have the expertise and specialised equipment for sampling aerosolised food allergens and can determine the presence and level of airborne allergens in manufacturing settings. This is an important risk assessment consideration in food manufacturing settings, particularly those using easily aerosolised materials (for example, flours & powders) and is relevant not just to unintentional allergen presence in foods but has implications for occupational health assessment and risk of employees developing occupational allergies.
Effective detection and quantification of food allergens, the development of reference doses and a QRA approach are key elements in effective food allergen risk assessment. Indoor Biotechnologies molecular approach to food allergy provides a unique analytical solution (MARIA® for Food) for the management of inadvertent exposure to food allergens and the development of innovative therapeutic products for the treatment of food allergy.
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