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The importance of EN ISO 15189 accreditation of allergen-specific IgE determination for reliable in vitro allergy diagnosis

2014; Wiley; Volume: 70; Issue: 2 Linguagem: Inglês

10.1111/all.12546

1398-9995

Claude Lambert, A. Sarrat, F. Bienvenu, Séverine Brabant, P. Nicaise‐Roland, Marie‐Alexandra Alyanakian, P.A. Apoil, Claude Capron, R. Couderc, Bertrand Evrard, Délia Jaby, Caroline Hémont, C. Lainé, M Lelong, Delphine Mariotte, J. Martinet, Gilles Rénier, J. Sainte‐Laudy, Thierry Tabary, E. Treiner, B. Uring‐Lambert, C. Vigneron, M. Vivinus, F. Witthuhn, Joana Vitte,

Contact Dermatitis and Allergies

Background Allergen-specific serum immunoglobulin E detection and quantification have become an important step in allergy diagnosis and follow-up. In line with the current trend of laboratory test accreditation to international standards, we set out to design and assess an accreditation procedure for allergen-specific serum IgE. Methods Method validation according to the accreditation procedure under the EN ISO 15189 standard was carried out for allergen-specific immunoglobulin E determination using the fluoroimmunoenzymatic method ImmunoCAP® (ThermoFisher). Data were produced by 25 hospital laboratories in France. A total of 29 allergen specificities including mixes, extracts, and molecular allergens were assayed. Allergen-specific serum immunoglobulin E concentrations ranged from 0.1 to 100 kUA/l. Results Repeatability, reproducibility, and accuracy results fulfilled method validation criteria for automated laboratory tests and proved similar irrespective of the allergen specificity, allergen-specific serum immunoglobulin E concentration, or individual laboratory. Conclusion Allergen-specific serum immunoglobulin E determination with the fluoroimmunoenzymatic method ImmunoCAP® is a highly repeatable, reproducible, and accurate method which may be considered as a single analyte assay in view of the EN ISO 15189 accreditation procedure.