Mike Jentsch, Barry van der Strate, Marjolein Meddens, Marcus Meddens, Robert Schoevers
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Assessment of biomarker stability and assay performance parameters for medical diagnosis: a case study of diagnosis of major depressive disorder
Aim: Assessing the stability profiles and assay performance of 24 biomarker assays in 32 biomarker/body fluid combinations identified as relevant for prediction of major depressive disorder. Materials & methods: Combinations were tested for stability and assay performance with ELISA at different storage and freeze–thaw conditions in pooled samples of 40 patients. Results: Stability and assay performance issues were found in almost all cases except three biomarkers in urine and three in serum. Conclusion: This study shows that, to produce reliable measurement data, assessments of stability and assay performance are essential. In development, other quality assurance parameters might be implemented to increase the level of measurement reliability by increasing assay performance control.
期刊介绍：
Biomarkers are physical, functional or biochemical indicators of physiological or disease processes. These key indicators can provide vital information in determining disease prognosis, in predicting of response to therapies, adverse events and drug interactions, and in establishing baseline risk. The explosion of interest in biomarker research is driving the development of new predictive, diagnostic and prognostic products in modern medical practice, and biomarkers are also playing an increasingly important role in the discovery and development of new drugs. For the full utility of biomarkers to be realized, we require greater understanding of disease mechanisms, and the interplay between disease mechanisms, therapeutic interventions and the proposed biomarkers. However, in attempting to evaluate the pros and cons of biomarkers systematically, we are moving into new, challenging territory.
Biomarkers in Medicine (ISSN 1752-0363) is a peer-reviewed, rapid publication journal delivering commentary and analysis on the advances in our understanding of biomarkers and their potential and actual applications in medicine. The journal facilitates translation of our research knowledge into the clinic to increase the effectiveness of medical practice.
As the scientific rationale and regulatory acceptance for biomarkers in medicine and in drug development become more fully established, Biomarkers in Medicine provides the platform for all players in this increasingly vital area to communicate and debate all issues relating to the potential utility and applications.
Each issue includes a diversity of content to provide rounded coverage for the research professional. Articles include Guest Editorials, Interviews, Reviews, Research Articles, Perspectives, Priority Paper Evaluations, Special Reports, Case Reports, Conference Reports and Company Profiles. Review coverage is divided into themed sections according to area of therapeutic utility with some issues including themed sections on an area of topical interest.
Biomarkers in Medicine provides a platform for commentary and debate for all professionals with an interest in the identification of biomarkers, elucidation of their role and formalization and approval of their application in modern medicine. The audience for Biomarkers in Medicine includes academic and industrial researchers, clinicians, pathologists, clinical chemists and regulatory professionals.
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