Performance criteria for the verification of IgE and tryptase assay methods: recommendations from the AllergoBioNet network - Université de Rennes Accéder directement au contenu
Article Dans Une Revue Annales de Biologie Clinique Année : 2020

Performance criteria for the verification of IgE and tryptase assay methods: recommendations from the AllergoBioNet network

Anne Sarrat
  • Fonction : Auteur
Rémy Couderc
  • Fonction : Auteur correspondant
Pol-André Apoil
  • Fonction : Auteur
  • PersonId : 1049110
Angelique Grenier
  • Fonction : Auteur
Delphine Mariotte
  • Fonction : Auteur
Stephanie Rogeau
  • Fonction : Auteur

Résumé

Accreditation of an in vitro diagnostic assay according to the NHENI/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 infra-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 and tryptase assays.

Dates et versions

hal-03150166 , version 1 (23-02-2021)

Identifiants

Citer

Anne Sarrat, Rémy Couderc, Marie-Alexandra Alyanakian, Pol-André Apoil, Céline Beauvillain, et al.. Performance criteria for the verification of IgE and tryptase assay methods: recommendations from the AllergoBioNet network. Annales de Biologie Clinique, 2020, 78 (3), pp.329-342. ⟨10.1684/abc.2020.1549⟩. ⟨hal-03150166⟩
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