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

Background Allergen- specificserum immunoglobulin Edetection and quantification have become an important step in allergy diagnosis and follow-up. In line with the current trend of laboratory test accreditationto international standards, we set out to design and assess an accreditationprocedure for allergen- specificserum IgE. Methods Method validation according to the accreditationprocedure under the EN ISO 15189 standard was carried out for allergen- specific immunoglobulin Edetermination using the fluoroimmunoenzymatic method ImmunoCAP® (ThermoFisher). Data were produced by 25 hospital laboratories in France. A total of 29 allergen specificitiesincluding mixes, extracts, and molecular allergenswere assayed. Allergen- specificserum immunoglobulin Econcentrations 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- specificserum immunoglobulin Econcentration, or individual laboratory. Conclusion Allergen- specificserum immunoglobulin Edetermination 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 accreditationprocedure.