Establishing Target Values for Analytical Performance Specifications in the Quality Management of Tumor Marker Tests Using Biological Variation Data

BodyIn clinical laboratories, the implementation of a quality management system (QMS) is essential for ensuring the reliability of test results [1].A comprehensive QMS includes internal and external quality control, assessments of precision and linearity, method comparison studies, parallel testing during reagent lot changes, and delta checks [2].In addition, each laboratory should establish its own analytical performance specification (APS) targets to support effective quality management.Tumor marker testing represents a major component of diagnostic immunology and clinical chemistry.These assays measure tumor-related biomarkers in blood and play a critical role in diagnosing various cancers, guiding and monitoring treatment, and detecting recurrence [3].As the clinical significance of each tumor marker differs and assays are performed across diverse analytical