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


Autoria(s): Lambert, C; Sarrat, A; Bienvenu, F; Brabant, S; Nicaise-Roland, P; Alyanakian, M-A; Apoil, P-A; Capron, C; Couderc, R; Evrard, B; Jaby, D; Hémont, C; Lainé, C; Lelong, M; Mariotte, D; Martinet, J; Renier, Gilles; Sainte-Laudy, J; Tabary, T; Treiner, E; Uring-Lambert, B; Vigneron, C; Vivinus, M; Witthuhn, F; Vitte, J
Contribuinte(s)

Groupe d'Etude des Interactions Hôte-Parasite (GEIHP) ; Université d'Angers (UA)

Data(s)

2015

Resumo

International audience

<p>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.</p><p>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.</p><p>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.</p><p>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.</p>

Identificador

hal-01392258

https://hal.archives-ouvertes.fr/hal-01392258

DOI : 10.1111/all.12546

OKINA : ua11186

Idioma(s)

en

Publicador

HAL CCSD

Relação

info:eu-repo/semantics/altIdentifier/doi/10.1111/all.12546

Fonte

ISSN: 1398-9995

Allergy

https://hal.archives-ouvertes.fr/hal-01392258

Allergy, 2015, 70 (2), pp.180-6. <10.1111/all.12546>

Palavras-Chave #accreditation #allergen-specific serum IgE #EN ISO 15189 #[SDV] Life Sciences [q-bio]
Tipo

info:eu-repo/semantics/article

Journal articles