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, 2 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 semiquantitative data and allergen-class results of the 4 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, a cautious trend was found towards an alignment of the results and interlaboratory comparability, with the exception of 1 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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| http://dx.doi.org/10.1016/j.anai.2018.07.016 | DOI Listing |
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