We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
The importance of EN ISO 15189 accreditation of allergen-specific IgE determination for reliable in vitro allergy diagnosis.
- Authors
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.; Rénier, G.; Sainte‐Laudy, J.; Tabary, T.; Treiner, E.
- Abstract
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.
- Subjects
ALLERGY diagnosis; IMMUNOGLOBULIN E; HOSPITAL accreditation; FLUOROIMMUNOASSAY; REPRODUCIBLE research
- Publication
Allergy, 2015, Vol 70, Issue 2, p180
- ISSN
0105-4538
- Publication type
Article
- DOI
10.1111/all.12546