Evaluation of the manufacturer-dependent differences in sIgE results for indoor allergens

Publication date: Available online 17 July 2018

Source: Annals of Allergy, Asthma & Immunology

Author(s): Nathalie Wojtalewicz, Kathrin Kabrodt, Sabine Goseberg, Ingo Schellenberg

Abstract

Background

Even though allergies are an important health issue, the detected amount of allergen-specific IgE (sIgE) has differed widely between manufacturers in the past, and even as recently as this year. These discrepancies hinder diagnostics and can even impact allergen immunotherapy.

Objective

The aim of this study was to evaluate the development and status quo of the quality of in vitro diagnostic testing for house dust mites (HDM) and cat epithelium, two important indoor allergen sources. Methods: We analyzed data on the allergen sources European HDM, American HDM and cat epithelium, which were collected by the Society for Promoting Quality Assurance in Medical Laboratories (INSTAND e.V.) during 7 years as part of External Quality Assessment schemes (EQAs). A pseudoanonymized comparison was made of the semi-quantitative data and allergen-class results of the four main suppliers of in vitro diagnostic sIgE tests. Coefficients of variation (CV) were determined in order to evaluate interlaboratory comparability.

Results

In vitro allergy diagnostic testing for the major allergen sources HDM and cat epithelium still reveals manufacturer-dependent differences. Despite this, there appears to be a cautious trend towards an alignment of the results and interlaboratory comparability with the exception of one supplier.

Conclusion

Even though these results are promising, future EQAs have to be closely monitored to ensure this positive trend is not just a snapshot.

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