Establishing Target Values for Analytical Performance Specifications in the Quality Management of Tumor Marker Tests Using Biological Variation Data
Year: 2026
Type: article
Abstract: 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 생물학적 변이에 근거한 종양표지자 검사의 품질관리를 위한 분석 수행 사양 목표치 설정 Establishing Target Values for Analytical Performance Specifications in the Quality Management of Tumor
Source: Laboratory Medicine Online
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W7165807107
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