Biological and Analytical Variation of Clinical Biomarker Testing: Implications for Biomarker-guided Therapy
Abstract
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 CVA), ranging from 5-20 %. There are also variances within a subject over time (CVI) and between subjects (CVG). 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.
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The small changes observed in MR-proANP are less than estimates for clinically relevant changes, which weakens the results.
“The small changes that we observed are less than these estimates, which weaken our results”
From Effect of liraglutide on atrial natriuretic peptide, adrenomedullin, and copeptin in PCOS (2018) · cites this paper as [45]
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Biologic variability of C-reactive protein: Is the available information reliable?
Braga, F., & Panteghini, M. (2012) · Clinica Chimica Acta · doi:10.1016/j.cca.2012.04.010 · Cited by 36 · see citing works
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Cardiac troponins: from myocardial infarction to chronic disease
Park, K. C., Gaze, D. C., Collinson, P. O., & Marber, M. S. (2017) · Cardiovascular Research · doi:10.1093/cvr/cvx183 · Cited by 510 · see citing works
Trimethylamine-N-oxide and its biological variations in vegetarians.
Obeid, R., Awwad, H. M., Keller, M., & Geisel, J. (2017) · European Journal of Nutrition · doi:10.1007/s00394-016-1295-9 · Cited by 38 · see citing works
Effect of liraglutide on atrial natriuretic peptide, adrenomedullin, and copeptin in PCOS
Frøssing, S., Nylander, M., Kistorp, C., Skouby, S. O., & Faber, J. (2018) · Endocrine Connections · doi:10.1530/ec-17-0327 · Cited by 38 · see citing works
- Authors
- Wu, A. H. B.
- Affiliations
- San Francisco General Hospital (US)
- Corresponding author
- Wu, Alan H. B.
- ORCID
- Wu, Alan H. B.
- Venue
- Current Heart Failure Reports
- Published
- 2013-09-15
- Volume
- 10
- Issue
- 4
- Pages
- 434-440
- ISSN
- 1546-9530 (ISSN-L)
- 1546-9549
- OpenAlex
- W2071887213
- Cited by
- 45
- References
- 1
- Citations by year
- 2026: 2 · 2025: 3 · 2023: 2 · 2022: 3 · 2021: 1 · 2020: 4 · 2019: 4 · 2018: 4 · 2017: 5 · 2016: 9 · 2015: 5 · 2014: 3
- FWCI
- 0.63
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Current Heart Failure Reports (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Acute Myocardial Infarction Research
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Keywords
- serum biomarkers, analytical variability, within-person variability, between-subject variability, coefficient of variation, reference change value, index of individuality, homeostatic set point, cardiac troponin, acute coronary syndrome, natriuretic peptides, galectin-3, soluble ST2, heart failure, cardiovascular risk, statin-induced myopathy, liver function tests, biomarker-guided therapy
- MeSH terms
- Cardiovascular Diseases, Diagnostic Techniques, Cardiovascular, Diagnostic Tests, Routine, Humans, Reference Values, Troponin, Biomarkers, Drug Monitoring, Risk Assessment, Acute Coronary Syndrome
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