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Background: Allergy is a form of immune-mediated exaggerated sensitivity hypersensitivity to a substance that is either inhaled, swallowed, injected or comes into contact with the skin. Foreign substances that provoke allergies are called allergens. It has been claimed that multiplex allergen testing may help in diagnosing the cause of symptoms in patients with an unclear cause of allergy or who are allergic to more than one substance.

Objectives: To evaluate multiplex allergen testing [devices that can measure the presence of multiple immunoglobulin E IgE antibodies in a patient's blood at the same time], by assessing 1 clinical effectiveness allergy symptoms, incidence of acute exacerbations, mortality, adverse events of testing and treatment, health-care presentations or admissions, health-related quality of life ; 2 effects on treatment diet, immunotherapy medications, other potential testing ; 3 any additional diagnostic information provided by multiplex allergen testing; and 4 cost-effectiveness cost of different assessment strategies.

The methodological quality of included studies was assessed using appropriate published tools or a review-specific tool designed by the project team.

Studies were summarised in a narrative synthesis. Owing to a lack of data on the clinical effectiveness of multiplex allergen testing, no long-term cost-effectiveness model was developed. A conceptual model structure was developed and cost analyses were performed to examine the short-term costs of various possible diagnostic pathways. Results: Fifteen studies were included in the review. There was some indication that the use of ImmunoCAP ISAC testing may be useful to guide decisions on the discontinuation of restrictive diets, the content of allergen-specific immunotherapy SIT prescriptions, and whether or not patients should receive SIT.

However, none of the studies that we identified reported any information on clinical outcomes subsequent to changes in treatment or management. Detailed cost analyses suggested that multiplex allergen testing would have to result in a substantial reduction of the proportions of patients receiving single IgE testing and oral food challenge tests in order to be cost-saving in the short term.

Conclusions: No recommendations for service provision can be made based on the analyses included in this report.

It is suggested that a consensus-based protocol for the use of multiplex allergen testing be developed. The clinical effectiveness and cost-effectiveness of the proposed protocol should then be assessed by comparing long-term clinical and quality of life outcomes and resource use in patients managed using the protocol with those managed using a standard diagnostic pathway.

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Popescu FD, Vieru M. Popescu FD, et al. World J Methodol. The potential of component-resolved diagnosis in laboratory diagnostics of allergy. Dodig S, et al. Biochem Med Zagreb. Epub Apr Diagnostic accuracy, risk assessment, and cost-effectiveness of component-resolved diagnostics for food allergy: A systematic review. Flores Kim J, et al. Epub Mar 2. Debates in Allergy Medicine: Allergy skin testing cannot be replaced by molecular diagnosis in the near future.

Larenas-Linnemann D, et al. World Allergy Organ J. Debates in allergy medicine: Molecular allergy diagnosis with ISAC will replace screenings by skin prick test in the future. Jensen-Jarolim E, et al. Publication types Review Actions. Systematic Review Actions. Cost-Benefit Analysis Actions. Diet Actions. Humans Actions. Models, Econometric Actions. Technology Assessment, Biomedical Actions. United Kingdom Actions. Substances Allergens Actions. Immunoglobulin E Actions.

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ImmunoCAP ISAC – When you need the bigger picture in allergy

It is the result of a combination of innovative biochip technology and cutting edge research in molecular allergology. This advanced technology enables measurement of IgE antibodies to a fixed panel of components from 51 allergen sources in a single step, using only 30 ul of serum or plasma. ImmunoCAP ISAC is the first multiplex in vitro diagnostic tool for the allergy specialist that is based exclusively on allergen components. Thermo Scientific: Helping scientists meet the challenges they face in the lab or in the field every day.


ImmunoCAP ISAC 112 and Microtest for multiplex allergen testing

NCBI Bookshelf. Health Technology Assessment, No. Multiplex allergen tests are molecular diagnostic tests, in the form of a glass slide, which can simultaneously test for the presence of multiple antibodies in blood samples up to 51 allergen sources. Multiplex allergen testing is likely to be used in secondary care settings or specialist tertiary care centres, as an addition to allergen challenge testing and in addition to, or in place of, single immunoglobulin E IgE antibody testing.


ImmunoCAP ISAC for a range of sIgE antibody information




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