Abstract

BackgroundSkin prick tests (SPTs) are essential for the diagnosis of IgE-mediated allergy and are influenced by extract quality, biological potency and concentration of allergen.MethodsIn this open multicentre study 431 patients, aged 18–64 years were enrolled. Patients had a history of IgE-mediated allergy and a sensitisation (previous positive SPT of any manufacturer) against at least one of the investigated allergens: 6-grass pollen, house dust mite, birch and mugwort pollen. In our study, these allergens were tested in five concentrations each. To establish the optimal trade-off between sensitivity and specificity, the area under the receiver operating characteristic (ROC) curve was estimated by comparing the outcome of the SPT with three methods referred to as ‘reference methods’ (specific IgE, clinical case history and a previous SPT).ResultsFor all allergens and reference methods, the area under the ROC curves were highly significant (p < 0.001). Specific IgE reference method resulted in the largest area under the curve (AUC) for all allergens (0.80–0.90) followed by previous SPT (0.70–0.87) and case history (0.65–0.74). Sensitivity of SPT increased with increasing concentration and specificity decreased. For all allergens, compared to specific IgE, the highest sensitivity (specificity at least 80%) was observed for the SPT solution of 50,000 Standardised Units (SU)/mL (grass pollen, birch pollen, house dust mite and mugwort).ConclusionIn this study, with a large number of patients, it was demonstrated that clinical case history, previous SPT and specific IgE measurement could all be used as reference methods for the assessment of sensitivity/specificity of SPT solutions. The comparison of SPT with specific IgE resulted in the largest AUC. The highest sensitivity was observed for the SPT solution of 50,000 SU/mL.Trial registration EudraCT: 2006-005304-14.

Highlights

  • Skin prick tests (SPTs) are essential for the diagnosis of IgE-mediated allergy and are influenced by extract quality, biological potency and concentration of allergen

  • The specific diagnosis of IgE-mediated allergy to aeroallergens is usually based on the correlation between clinical symptoms and medical history supplemented by diagnostic tests [1]

  • Our data, measured with the ImmunoCAPTM system, are in accordance with these reports: the highest sensitivity including a specificity of at least 80% was observed for the SPT solution of 50,000 Standardised Units (SU)/mL for all four allergens tested

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Summary

Introduction

Skin prick tests (SPTs) are essential for the diagnosis of IgE-mediated allergy and are influenced by extract quality, biological potency and concentration of allergen. The specific diagnosis of IgE-mediated allergy to aeroallergens is usually based on the correlation between clinical symptoms and medical history supplemented by diagnostic tests [1]. The clinical history is the basis for suspecting a type I IgE-mediated allergy, while the diagnostic tests are used to confirm or exclude the presence. The quality of allergen extract is of main significance as a wide variation in composition and allergen content between allergen extracts from different manufacturers exists. To achieve batch-to-batch consistency, in vitro standardisation of allergen extracts and determination of the biological activity are of crucial importance for the reliability of the test system

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