La diagnostica di laboratorio nel diabete di tipo 1 e il programma nazionale di screening: indicazioni SIPMeL-SIBioC

The laboratory plays a central role in the diagnostic pathway of type 1 diabetes (T1DM), contributing not only to diagnosis but also to disease staging and monitoring. In recent years, alongside traditionally used tests, new analytical approaches have been developed and progressively introduced, characterized by different methodological principles, diagnostic performance, levels of automation, and fields of clinical application. The aim of this joint work by the SIPMeL-SIBioC Inter-Society Study Group on Diabetes Mellitus and the SIPMeL Study Group on Autoimmunity is to provide a critical overview of the main laboratory diagnostic tools currently available for T1DM, analyzing their methodological principles, analytical performance, and clinical context of use. In particular, the strengths and limitations of the different diagnostic approaches are discussed, evaluating their application in various clinical settings, including diagnosis at onset, differential classification of diabetes forms, predictive screening, and functional monitoring. Through an integrated analysis of the different components of laboratory diagnostics, this contribution aims to provide practical guidance for selecting the most appropriate methodologies according to the clinical context and available laboratory resources, also in light of the recent expansion of the Italian national screening program for type 1 diabetes.