Proposed laboratory diagnostic workflow in the Italian national screening program for type 1 diabetes

Area of Science:

• Immunology
• Endocrinology
• Public Health

Background:

• Population screening for type 1 diabetes (T1D) using islet autoantibodies is crucial for early detection and prevention of diabetic ketoacidosis.
• Italy's Law 130/2023 mandates a national pediatric screening program for T1D and celiac disease.

Purpose of the Study:

• To describe a proposed national screening pathway for type 1 diabetes in Italian children.
• To address challenges in laboratory harmonization, confirmatory testing, and inter-center integration.

Main Methods:

• Decentralized screening of 5-6-year-old children using capillary blood and autoantibody assays.
• Centralized confirmation of positive results using antibody-specific testing and alternative platforms.
• Referral of confirmed cases to pediatric diabetes centers for monitoring.

Main Results:

• A multi-level diagnostic workflow combining regional and national laboratory capabilities is proposed.
• The model emphasizes harmonization and standardization for analytical reliability.
• Integration strategies are crucial for effective program implementation.

Conclusions:

• The proposed model offers a standardized approach to population-based T1D screening in Italy.
• Harmonization through quality assessment and research initiatives is vital for success.
• Effective implementation requires collaboration between regional and national laboratories.