Study of Indirect Methods to Define Reference Blood Test Ranges in Italy Including Age and Sex Differences Across Regions

What this Trial Is About

Reference intervals are important tools used to interpret laboratory test results. This research aims to evaluate indirect methods for determining these reference intervals using routine clinical laboratory data instead of relying on samples from actively recruited healthy individuals. The study focuses on improving accuracy and efficiency in defining reference intervals, particularly for complete blood count CBC parameters, and highlights the need for age-specific reference intervals due to variations in hemoglobin levels among the elderly. The study is observational and analyzes large-scale retrospective data collected from routine clinical laboratory tests across multiple Italian regions. It evaluates the RefineR statistical method, an open-source tool designed to distinguish normal from pathological data efficiently. The study will assess regional differences, establish age- and sex-specific reference intervals, and evaluate variations caused by different laboratory instruments over a period of up to three years. Participants are not actively recruited since the study uses existing laboratory data. Researchers will analyze these data to define reference intervals and compare results across regions, age groups, and testing platforms. The primary outcome is the definition of indirect reference intervals for CBC parameters. Secondary outcomes include assessments of regional and instrument variations. The study will run from October 2025 to June 2028, with no direct participant involvement beyond data analysis.

Reference Intervals With Indirect Methods in Italy