PRS1 Cost-Utility of Molecular IgE in Vitro Diagnostics (IVD) in Children Suspected With Peanut Allergy Compared to Most Used Diagnostics in Selected Asian Markets

Hermansson, L.L.; Glaumann, Susanne; Mascialino, B.; Wang, L.L.; Nilsson, Caroline

doi:10.1016/j.jval.2012.08.223

Cited by 3 publications

(1 citation statement)

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“…None of the studies meeting our inclusion criteria evaluated the cost‐effectiveness of CRD or made mention of any economic considerations. The only relevant evidence identified was two manufacturer‐authored abstracts featuring Markov simulation‐based cost‐utility models for CRD vs DBPCFC for peanut allergy and one with unspecified methodology featuring multiple food allergies; contacting the authors confirmed there were no accompanying peer‐reviewed papers …”

Section: Resultsmentioning

confidence: 99%

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

Kim

McCleary

Nwaru

et al. 2018

Allergy

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BackgroundComponent‐resolved diagnostics (CRD) are promising tools for diagnosing food allergy, offering the potential to determine specific phenotypes and to develop patient‐tailored risk profiles. Nevertheless, the diagnostic accuracy of these tests varies across studies; thus, their clinical utility remains unclear. Therefore, we synthesized the evidence from studies investigating the diagnostic accuracy, risk assessment ability, and cost‐effectiveness of CRD for food allergy.MethodsWe systematically searched 10 electronic databases and four clinical trial registries for studies published from January 2000 to February 2017. The quality of included studies was assessed using QUADAS‐2. Due to heterogeneity, we narratively synthesized the evidence.ResultsEleven studies met inclusion criteria, altogether recruiting 1098 participants. The food allergies investigated were cow's milk, hen's egg, peanut, hazelnut, and shrimp. The components with the highest diagnostic accuracy for each allergen, along with their sensitivity‐specificity pairs, were as follows: Bos d 4 for cow's milk (62.0% and 87.5%), Gal d 1 for hen's egg (84.2% and 89.8% for heated egg, and 60.6% and 97.1% for raw egg), Ara h 6 for peanut (94.9% and 95.1%), Cor a 14 for hazelnut (100% and 93.8%), and Lit v 1 for shrimp (82.8% and 56.3%) allergy.ConclusionSelected components of cow's milk, hen's egg, peanut, hazelnut, and shrimp allergen showed high specificity, but lower sensitivity. However, few studies exist for each component, and studies vary widely regarding the cutoff values used, making it challenging to synthesize findings across studies. Further research is needed to determine clinically appropriate cutoff values, risk assessment abilities, and cost‐effectiveness of CRD approaches.

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Section: Resultsmentioning

confidence: 99%

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

Kim

McCleary

Nwaru

et al. 2018

Allergy

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A Retrospective Clinical Audit of the ImmunoCAP ISAC 112 for Multiplex Allergen Testing

Erskine

Brooker

Leech

et al. 2020

Int Arch Allergy Immunol

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Introduction: Complex cases of multiple allergies can be particularly difficult to diagnose using standard methods such as skin prick tests and assessment of a patient’s allergic history. Multiplex allergy testing may improve outcomes for allergy patients by avoiding misdiagnosis and providing reassurance. The ImmunoCAP Immuno Solid-Phase Allergen Chip (ISAC) 112 is a CE-marked, molecular, multiplex, allergy test that can test for IgE antibodies to 112 components from 51 allergen sources. However, its clinical utility is unknown and is difficult to estimate due to the complexity of the diagnostic pathway in which it is used. Objective: To assess how the ImmunoCAP ISAC 112 is currently being used in UK practice. The patient populations in which it may have the most benefit were examined, and the sequence of other tests implemented alongside ISAC was determined. Methods: A retrospective audit of 100 patient cases from 2 UK tertiary allergy clinics was performed. Fifty paediatric and fifty adult cases were selected for audit. The indications for ordering an ISAC test, the other tests used alongside ISAC, and changes in management actioned by the ISAC test were investigated. Results: 73.6% of paediatric and 78% of adult patients referred for an ISAC test were suspected to have multiple sensitizations. The sequence of testing varied greatly between cases, but 70% of adult and 98% of paediatric patients had at least one other investigation prior to an ISAC test. In most cases, ISAC testing confirmed clinical suspicion. Conclusions: A prospective research study is necessary to further investigate the clinical utility and cost-effectiveness of the ISAC. A UK national registry would be of great benefit but will require a large resource base.

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

Westwood

Ramaekers

Lang

et al. 2016

Health Technol Assess

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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.

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PRS1 Cost-Utility of Molecular IgE in Vitro Diagnostics (IVD) in Children Suspected With Peanut Allergy Compared to Most Used Diagnostics in Selected Asian Markets

Cited by 3 publications

References 0 publications

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

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

A Retrospective Clinical Audit of the ImmunoCAP ISAC 112 for Multiplex Allergen Testing

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

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