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

Performance criteria for the verification of IgE and tryptase assay methods: recommendations from the AllergoBioNet network. Ann Biol Clin (Paris). 2020 May 15;: Authors: Sarrat A, Couderc R, Alyanakian MA, Apoil PA, Beauvillain C, Chollet L, Chrétien P, Cirée A, Cypriani B, Dumontet E, Evrard B, Garnier L, Grenier A, Guérin V, Hémont C, Léon A, Mariotte D, Nicaise-Roland P, Pernollet M, Rogeau S, Tabary T, Uring-Lambert B, Vivinus M, Vitte J Abstract 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 th...
Source: Annales de Biologie Clinique - Category: Biochemistry Authors: Tags: Ann Biol Clin (Paris) Source Type: research