Standardization of generic pre-analytical procedures for in vitro diagnostics for personalized medicine

Oelmueller, Uwe

doi:10.1016/j.nbt.2020.07.003

Cited by 6 publications

(4 citation statements)

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“…Examples are the quality management work of BBMRI-ERIC 90 and BBMRI.de 91 and initiatives such as the new ISO 20387:2018 biobanking standard 10 and SPIDIA4P, which publishes specific ISO technical standards for the preanalytical phase of sample collection. 92 From a national perspective we should not reinvent the wheel but make sure we connect to these initiatives and translate them to our own workflows. Still, improving harmonization and standardization has been a topic for years 84 , 85 , 87 , 93 , 94 ; and will be for years to come.…”

Section: Discussionmentioning

confidence: 99%

Recommendations for a Dutch Sustainable Biobanking Environment

Stijl

Manders

Eijdems

2021

Biopreservation and Biobanking

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Biobanks and their collections are considered essential for contemporary biomedical research and a critical resource toward personalized medicine. However, they need to operate in a sustainable manner to prevent research waste and maximize impact. Sustainability is the capacity of a biobank to remain operative, effective, and competitive over its expected lifetime. This remains a challenge given a biobank's position at the interplay of ethical, societal, scientific, and commercial values and the difficulties in finding continuous funding. In the end, biobanks are responsible for their own sustainability. Still, biobanks also depend on their surrounding environment, which contains overarching legislative, policy, financial, and other factors that can either impede or promote sustainability. The Biobanking and Biomolecular Research Infrastructure for The Netherlands ( ) has worked on improving the national environment for sustainable biobanking. In this article, we present the final outcomes of this project. First, we summarize the current overarching challenges of the Dutch biobanking landscape. These challenges were gathered during workshops and focus groups with Dutch biobanks and their users, for which the full results are described in separate reports. The main overarching challenges relate to sample and data quality, funding, use and reuse, findability and accessibility, and the general image of biobanks. Second, we propose a package of recommendations—across nine themes—toward creating overarching conditions that stimulate and enable sustainable biobanking. These recommendations serve as a guideline for the Dutch biobanking community and their stakeholders to jointly work toward practical implementation and a better biobanking environment. There are undoubtedly parallels between the Dutch situation and the challenges found in other countries. We hope that sharing our project's approach, outcomes, and recommendations will support other countries in their efforts toward sustainable biobanking.

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Section: Discussionmentioning

confidence: 99%

Recommendations for a Dutch Sustainable Biobanking Environment

Stijl

Manders

Eijdems

2021

Biopreservation and Biobanking

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“…To achieve a standardization, the current new Horizon 2020 SPIDA4P consortium project (2017-2020) is working as a coordination and support action to broaden the portfolio of standards for preanalytical workflows. The aim is to finally generate and implement a comprehensive portfolio of 22 pan-European pre-analytical CEN/ Technical Specifications and ISO/International Standards, addressing important pre-analytical workflows as applied to personalized medicine (www.spidia.eu) (accessed on 15 September 2021) [34,35].…”

Section: Pre-analytical Blood Sample Handlingmentioning

confidence: 99%

Technical Challenges for CTC Implementation in Breast Cancer

Ramos-Medina

López-Tarruella

Monte-Millán

et al. 2021

Cancers

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Breast cancer is the most common neoplasm in women worldwide. Tissue biopsy, currently the gold standard to obtain tumor molecular information, is invasive and might be affected by tumor heterogeneity rendering it incapable to portray the complete dynamic picture by the absence of specific genetic changes during the evolution of the disease. In contrast, liquid biopsy can provide unique opportunities for real-time monitoring of disease progression, treatment response and for studying tumor heterogeneity combining the information of DNA that tumors spread in the blood (circulating tumor DNA) with CTCs analysis. In this review, we analyze the technical and biological challenges for isolation and characterization of circulating tumor cells from breast cancer patients. Circulating tumor cell (CTC) enumeration value is included in numerous clinical studies due to the prognostic’s role of these cells. Despite this, there are so many questions pending to answer. How to manage lymphocytes background, how to distinguish the CTCs subtypes or how to work with frozen samples, are some of the issues that will discuss in this review. Based on our experience, we try to address these issues and other technical limitations that should be solved to optimize the standardization of protocols, sample extraction procedures, circulating-tumor material isolation (CTCs vs. ctDNA) and the very diverse methodologies employed, aiming to consolidate the use of CTCs in the clinic. Furthermore, we think that new approaches focusing on isolation CTCs in other body fluids such as cerebrospinal or ascitic fluid are necessary to increase the opportunities of circulating tumor cells in the practice clinic as well as to study the promising role of CTC clusters and their prognostic value in metastatic breast cancer.

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“…To overcome these challenges, large consortia and societies have developed standards ensuring highest quality of blood samples for subsequent liquid biopsy analysis. These include the European Liquid Biopsy Society (ELBS) (9), CancerID (10), Standardization of generic Pre-analytical procedures for In-vitro DIAgnostics for Personalized Medicine (SPIDIA) (11,12), BLOODPAC (13) and the International Liquid Biopsy Standardization Alliance (ILSA) (14). These efforts have resulted in liquid biopsy pre-analytical standards provided by the International Standards Organisation (ISO) and Technical Specifications from the European Committee for Standardization (CEN/TS).…”

Section: Introductionmentioning

confidence: 99%

Clinical application of ISO and CEN/TS standards for liquid biopsies - information everybody wants but nobody wants to pay for

Bonstingl,

Skofler,

Ulz

et al. 2023

Preprint

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BackgroundLiquid biopsies are emerging as valuable clinical biomarkers for cancer monitoring. Despite increasing clinical use, standardization remains a challenge. ISO and CEN/TS standardized workflows exist, but their integration into clinical practice is underdeveloped. We aimed to assess the applicability of ISO and CEN/TS liquid biopsy standards in a real-world clinical setting.MethodsWe evaluated 659 peripheral blood samples from advanced prostate cancer patients against ISO and CEN/TS standards and tracked all essential criteria. This included assessing tube filing level, complete timing from blood draw until storage, transport conditions, temperature control, hemolysis score and tube draw order and its effects on hemolysis.ResultsAmong 659 samples, 92.4% (609/659) met the essential criteria for ISO and CEN/TS compliance. In total 83.8% (552/659) of blood collection tubes had high fill levels above 80% of nominal filing level. In our advanced prostate cancer cohort, 12.9% (40/311) of the evaluated plasma samples were hemolytic. Within the draw order of five blood collection tubes, hemolysis did not significantly increase from tube one to five. The complete ccfDNA ISO and CTC CEN/TS workflows were completed within an average of 168 (+/- 71 min) and 248 minutes (+/- 76 min), respectively, from blood draw until storage.ConclusionsOur study demonstrates the feasibility and benefits of adhering to ISO and CEN/T standards in a clinical liquid biopsy study. ISO and CEN/TS standards revealed that hemolysis is a common phenomenon in pre-treated advanced prostate cancer patients, as we eliminated pre-analytical errors as cause.

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Standardization of generic pre-analytical procedures for in vitro diagnostics for personalized medicine

Cited by 6 publications

References 0 publications

Recommendations for a Dutch Sustainable Biobanking Environment

Recommendations for a Dutch Sustainable Biobanking Environment

Technical Challenges for CTC Implementation in Breast Cancer

Clinical application of ISO and CEN/TS standards for liquid biopsies - information everybody wants but nobody wants to pay for

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