Biological and Analytical Variation of Clinical Biomarker Testing: Implications for Biomarker-guided Therapy

• Published in: Current heart failure reports Vol. 10; no. 4; pp. 434 - 440
• Main Author: Wu, Alan H. B.
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.12.2013
• Subjects: Acute Coronary Syndrome - diagnosis; Biomarkers - blood; Biomarkers of Heart Failure (WHW Tang; Cardiac Surgery; Cardiology; Cardiovascular Diseases - diagnosis; Cardiovascular Diseases - drug therapy; Diagnostic Techniques, Cardiovascular; Diagnostic Tests, Routine; Drug Monitoring - methods; Humans; Imaging; Internal Medicine; Medicine; Medicine & Public Health; Radiology; Reference Values; Risk Assessment - methods; Section Editor; Troponin - blood; Vascular Surgery; Heart failure; Biological variation; Acute coronary syndromes; Analytical variation; Cardiovascular disease risk
• ISSN: 1546-9530; 1546-9549; 1546-9549
• DOI: 10.1007/s11897-013-0156-6

Testing for serum-based biomarkers are essential for diagnosis, risk stratification, and management of patients with cardiovascular disease. All biomarker assays have inherent analytical variability (coefficient of variance CV A ), ranging from 5–20 %. There are also variances within a subject over time (CV I ) and between subjects (CV G ). Variances are determined by experimentation under controlled conditions on healthy subjects. Once measured, the index of individuality (II), reference change value (RCV), and number of samples to establish a homeostatic set point can be calculated. These attributes affect how results of biomarker tests are interpreted in routine clinical practice such as cardiac troponin for acute coronary syndromes, the natriuretic peptides, galectin-3 and sST2 for heart failure, lipids and lipoproteins for primary cardiovascular disease risk, and liver function tests and skeletal muscle biomarkers for detecting complications from statin use.