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


CONCLUSIONS
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.
Laboratoire d'Immunologie, Pôle de Biologie-Pathologie, CHU St Etienne, Saint-Etienne, France.
C
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Lambert
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Sarrat
F
F
Bienvenu
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Brabant
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P
Nicaise-Roland
M-A
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Alyanakian
P-A
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Apoil
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Capron
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R
Couderc
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Evrard
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Jaby
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Hémont
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Lainé
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Lelong
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Mariotte
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Martinet
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Rénier
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Sainte-Laudy
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Tabary
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Treiner
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Uring-Lambert
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Vigneron
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Vivinus
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Witthuhn
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Vitte
D000485:Allergens / Q000276:immunology*; D015200:Fluoroimmunoassay / Q000379:methods* / Q000592:standards*; D006801:Humans; D006967:Hypersensitivity / Q000175:diagnosis* / Q000453:epidemiology* / Q000276:immunology; D007073:Immunoglobulin E / Q000276:immunology*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D000485:Allergens; D007073:Immunoglobulin E
EN ISO 15189; accreditation; allergen-specific serum IgE