Open AccessPerformance criteria for the verification of IgE and tryptase assay methods: recommendations from the AllergoBioNet network
Author(s) -
A. Sarrat,
Rémy Couderc,
MarieAlexandra Alyanakian,
P.A. Apoil,
Céline Beauvillain,
Lionel Chollet,
Pascale Chrétien,
Arnaud Cirée,
Benoît Cypriani,
Erwan Dumontet,
Bertrand Evrard,
L. Garnier,
Angélique Grenier,
Valérie Guerin,
Caroline Hémont,
Anthony Léon,
D. Mariotte,
Pascale Nicaise-Roland,
Martine Pernollet,
Stéphanie Rogeau,
Thierry Tabary,
B. UringLambert,
M. Vivinus,
Joana Vitte
Publication year - 2020
Publication title -
annales de biologie clinique
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.167
H-Index - 27
eISSN - 1950-6112
pISSN - 0003-3898
DOI - 10.1684/abc.2020.1549
Subject(s) - tryptase , immunoglobulin e , medicine , computer science , immunology , antibody , mast cell
Accreditation of an in vitro diagnostic assay according to the NF/EN/ISO 15189 standard requires to analyze its technical performance before implementation for routine use, and annually when reviewing effectiveness of quality controls. Performance is evaluated through repeatability, intermediate fidelity, accuracy and uncertainty of measurement. The coefficients of variation (CV) of the intra-assay and inter-assay precision tests must be compared with those of "peers" (results from laboratories employing the same method) and also with those obtained with "all methods", i.e., results from all laboratories performing the same assay, irrespective of the method. To our best knowledge, there is currently no French or international recommendation on what the acceptable limits of performance for specific IgE and tryptase assays should be. Therefore, the AllergoBioNet network of hospital allergy laboratories set out to characterize the performance of their current methods as a basis for the development of recommendations. The results provided by 24 centers were analyzed and led to consensus recommendations for specific IgE, total IgE and tryptase assays.