Zusammenfassung
Innerhalb der letzten Jahre wurden sowohl national als auch international zahlreiche Biobanken etabliert, die verschiedenste Kollektive humaner Biomaterialien und assoziierter phänotypischer Daten sammeln, aufbereiten und für Forschungszwecke zur Verfügung stellen. Vor dem Hintergrund der teilweise großen Heterogenität sowohl in der Struktur als auch in der Prozesslandschaft dieser Biobanken stellt sich die Frage nach der Vergleichbarkeit der Qualität der eingelagerten Bioproben und ihrer tatsächlichen Nutzbarkeit für die wissenschaftliche Forschung sowie der Interoperabilität von Biobanken. Im Folgenden soll daher ein Überblick zum Einfluss von Biobankprozessen auf die Probenqualität und über Möglichkeiten zur Qualitätssicherung für Forschungsbiobanken gegeben werden. Der Schwerpunkt liegt hierbei auf Biobanken die Flüssig- und Gewebeproben beinhalten. Beleuchtet werden zum einen die Rahmenbedingungen und der Einfluss präanalytischer Variablen auf die Qualität und Nutzbarkeit von Bioproben, darüber hinaus werden Möglichkeiten zur Qualitätssicherung dargestellt und deren Limitationen sowie mögliche Alternativen diskutiert. Da sowohl national als auch international großer Konsens darüber besteht, dass eine evidenzbasierte Standardisierung und Harmonisierung insbesondere in Bezug auf Qualitätsaspekte im Biobanking dringend erforderlich ist, werden im letzten Teil des Beitrags kurz die derzeit stattfindenden Normungsaktivitäten zur Entwicklung und Implementierung eines ISO-Standards für Biobanken dargestellt.
Abstract
During the last years, many biobanks that collect and provide biomaterials as well as associated phenotypical data have been established on national and international levels. However, due to the heterogeneity in structure and process landscape between biobanks, quality issues arise, which might affect equivalence of sample quality and thus usability of biomaterials for scientific research projects as well as interoperability of biobanks.
Here, we will give an overview on the influence of biobanking procedures on sample quality and on potential quality control measures for research biobanks, mainly focusing on tissue and liquid biomaterials. General infrastructural requirements as well as the influence of preanalytical variables affecting sample quality and usability are described and opportunities and drawbacks of different quality assurance procedures are discussed. As there is increasing consensus on national and international levels that evidence-based standardization and harmonization of biobank structures and workflows are urgently needed for quality-assured biobanking, recent activities in the development and implementation of an ISO Standard for biobanks will be illustrated in the last section of this article.
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Herpel, E., Schmitt, S. & Kiehntopf, M. Qualität von Biomaterialien im Biobanking von Flüssig- und Gewebeproben. Bundesgesundheitsbl. 59, 325–335 (2016). https://doi.org/10.1007/s00103-015-2294-3
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DOI: https://doi.org/10.1007/s00103-015-2294-3