A French consensus proposal: Analytical performance targets for total and allergen-specific IgE and total tryptase

Precision medicine allows thorough characterization of patients endotype in allergy and anaphylaxis, thanks to progress in diagnostic tests and biomarkers. Allergy tests must therefore offer reliable, robust, and proficient quantitative results in each patient. These requirements have led to the development of quality assurance programs for allergy laboratory assays and their implementation in virtually all clinical laboratories performing in vitro allergy diagnosis and follow-up. However, consensus analytical performance targets for allergy assays have not yet been established. Here, the multicentric French network of public clinical laboratories and the Working Group on in vitro allergy diagnosis of the French Society of Allergy define performance criteria for specific and total IgE and tryptase tests.