Allergy Diagnosis in Children and Adults: Performance of a New Point-of-Care Device, ImmunoCAP Rapid

BACKGROUND: Allergy is a serious problem affecting approximately 1 of 4 individuals. The symptoms with and without allergy etiology are often difficult to distinguish from each other without using an IgE antibody test. The aim of this study was to investigate the performance of a new point-of-care (POC) test for IgE antibodies to relevant allergens in Europe. METHODS: IgE antibodies from children and adults with allergies recruited from allergy clinics in Sweden and Spain were analyzed for 10 allergens, suitable for the age groups, using the new POC test and ImmunoCAP laboratory test. The IgE antibody level best discriminating between positive and negative results (the cutoff point) for the different allergens of the POC test and the efficacy of the POC and the ImmunoCAP laboratory tests for diagnosing allergy compared with that of clinical diagnosis were investigated. RESULTS: The estimated cutoffs for the different allergens in the POC test ranged from 0.70 to 2.56 kU(A)/L. Taking into account all positive allergen results in a given patient, the POC test could identify 95% of the patients with allergies. Seventy-eight percent of the allergen-specific physicians' diagnoses were identified and 97% of the negative ones. Most allergens exhibited good performance, identifying about 80% of clinically relevant cases. However, dog, mugwort, and wall pellitory would benefit from improvement. CONCLUSIONS: The POC test will be a valuable adjunct in the identification or exclusion of patients with allergies and their most likely offending allergens, both in specialist and general care settings.