ImmunoCAP® ISAC and Microtest for multiplex allergen testing in people with difficult to manage allergic disease: a systematic review and cost analysis

Abstract

BackgroundAllergy 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.ObjectivesTo 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).MethodsFifteen databases were searched from 2005 to April 2015, including MEDLINE (via OvidSp), MEDLINE In-Process Citations, MEDLINE Daily Update, PubMed (National Library of Medicine), EMBASE, Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment (HTA) database, Science Citation Index (SCI), Conference Proceedings Citation Index-Science (CPCI-S), BIOSIS Previews, Latin American and Caribbean Health Sciences Literature (LILACS), National Institute for Health Research (NIHR) HTA programme, and the US Food and Drug Administration (FDA); supplementary searches of conference proceedings and trials registries were performed. Review methods followed published guidance from the Cochrane Collaboration and the Centre for Reviews and Dissemination, University of York, UK. 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.ResultsFifteen studies were included in the review. The very limited available data indicated that the addition of multiplex allergen testing [ImmunoCAP®Immuno Solid-phase Allergen Chip (ISAC), Thermo Fisher Scientific/Phadia AB, Uppsala, Sweden] to standard diagnostic work-up can change the clinicians’ views on the diagnosis, management and treatment of patients. 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. There was some evidence that ImmunoCAP ISAC may be useful for discriminating allergens that are structurally similar and are recognised by the same IgE antibody (cross-immunoreactive). No data were available for Microtest (Microtest Matrices Ltd, London, UK). 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.ConclusionsNo 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.Study registrationThis study is registered as PROSPERO CRD42015019739.FundingThis project was a Diagnostic Assessment Report commissioned by the NIHR HTA programme on behalf of the National Institute for Health and Care Excellence.

Selective nut‐eating in peanut or tree nut allergic children—How can molecular allergology help?

“…In fact, in Finland, specific IgE to seed storage proteins were positive in only 6% (for both sesame and Brazil nut), 15% (for both walnut and pecan using Jug r 1), 25% (for hazelnut) and 27% (for cashew and pistachio using Ana o 3). Of note, some studies have suggested that the sensitivity of ISAC can be lower compared to skin tests and specific IgE, and this needs to be taken into account when interpreting the results of this method …”

“…Of note, some studies have suggested that the sensitivity of ISAC can be lower compared to skin tests and specific IgE, and this needs to be taken into account when interpreting the results of this method. 2 Thus, despite positive skin prick tests, the authors concluded that the majority of children could possibly introduce tree nuts into their diet. The authors proposed that if species-specific components are negative this was sufficient to rule out allergy to these tree nuts.…”

Allergen-Based Diagnostic: Novel and Old Methodologies with New Approaches

“…ISAC multiplex assay has been proposed to guide therapeutic decisions, e.g., the discontinuation of restrictive diets, the content of allergen-specific desensitization immunotherapy that may be useful to discriminate structurally similar allergens and cross-reactivity, and even to analyze the real sensitization profile in multi-sensitized patients to define whether they can receive a specific immunotherapy [33]. Allergen-Based Diagnostic: Novel and Old Methodologies with New Approaches http://dx.doi.org/10.5772/intechopen.69276 85…”

Diagnostic accuracy, risk assessment, and cost‐effectiveness of component‐resolved diagnostics for food allergy: A systematic review

“…While the diagnostic accuracy of various tests for food allergy was evaluated in our previous systematic review, CRD was not included . A health technology assessment was carried out to evaluate multiplex CRD assays, but clinical effectiveness (rather than diagnostic accuracy) was investigated . To the best of our knowledge, only one CRD‐specific diagnostic test accuracy (DTA) review has been conducted, but it focused solely on peanut allergy diagnosis .…”