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.
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.
Authors: Ignacio J Ansotegui; Giovanni Melioli; Giorgio Walter Canonica; Luis Caraballo; Elisa Villa; Motohiro Ebisawa; Giovanni Passalacqua; Eleonora Savi; Didier Ebo; R Maximiliano Gómez; Olga Luengo Sánchez; John J Oppenheimer; Erika Jensen-Jarolim; David A Fischer; Tari Haahtela; Martti Antila; Jean J Bousquet; Victoria Cardona; Wen Chin Chiang; Pascal M Demoly; Lawrence M DuBuske; Marta Ferrer Puga; Roy Gerth van Wijk; Sandra Nora González Díaz; Alexei Gonzalez-Estrada; Edgardo Jares; Ayse Füsun Kalpaklioğlu; Luciana Kase Tanno; Marek L Kowalski; Dennis K Ledford; Olga Patricia Monge Ortega; Mário Morais Almeida; Oliver Pfaar; Lars K Poulsen; Ruby Pawankar; Harald E Renz; Antonino G Romano; Nelson A Rosário Filho; Lanny Rosenwasser; Mario A Sánchez Borges; Enrico Scala; Gian-Enrico Senna; Juan Carlos Sisul; Mimi L K Tang; Bernard Yu-Hor Thong; Rudolf Valenta; Robert A Wood; Torsten Zuberbier Journal: World Allergy Organ J Date: 2020-02-25 Impact factor: 4.084
Authors: Ho Chin Kwok; Pui Man Lau; Shu Yuen Wu; Ho Pui Ho; Minghui Gao; Yiu Wa Kwan; Chun Kwok Wong; Siu Kai Kong Journal: Micromachines (Basel) Date: 2016-02-27 Impact factor: 2.891