Pre-analytical processes in medical diagnostics: New regulatory requirements and standards

Dagher, Georges; Becker, Karl‐Friedrich; Bonin, Serena; Foy, Carole A.; Gelmini, Stefania; Kubista, Mikael; Kungl, Penelope; Oelmueller, Uwe; Parkes, Helen C.; Pinzani, Pamela; Riegman, Peter; Schröder, Ulrike; Stumptner, Cornelia; Turano, Paola; Sjöback, Robert; Wutte, Andrea; Zatloukal, Kurt

doi:10.1016/j.nbt.2019.05.002

Cited by 41 publications

(22 citation statements)

References 46 publications

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“…We thank Quaresima et al [6] for their interest and relevant comments about the early detection of silent hypoxemia in COVID-19 patients based on prehospital pulse oximetry [1]. We agree that fingertip pulse oximeters may only provide approximate measurements of arterial blood oxygen saturation and that many intrinsic and extrinsic factors influence pulse oximetry values [6,7] beyond the preanalytical conditions required for certification [8]. One particularity of COVID-19-related acute respiratory failure was that, despite low blood oxygen concentration, the respiratory rate frequently remained close to normal, unlike in other acute respiratory failure etiologies [9].…”

Section: Valentina Quaresima and Marco Ferrari *mentioning

confidence: 87%

COVID-19: efficacy of prehospital pulse oximetry for early detection of silent hypoxemia

Quaresima

Ferrari

2020

Crit Care

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Section: Valentina Quaresima and Marco Ferrari *mentioning

confidence: 87%

COVID-19: efficacy of prehospital pulse oximetry for early detection of silent hypoxemia

Quaresima

Ferrari

2020

Crit Care

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“…12 Moreover, the new European Medical Devices Regulation 43 and In vitro Diagnostics Regulation 44 obligate industry to use well-documented samples for performance testing and validation of diagnostics. 81 Therefore, we recommend developing guidelines and criteria that academic biobanks should take into account if they plan to collaborate with companies in the future. On the Dutch national level, this could be done by the intended biobanking platform ( Theme 1: National Collaboration section) in collaboration with the Association Innovative Medicines, the Dutch representative body of the pharmaceutical industry.…”

Section: Recommendations For Creating the Right Conditions For Sustainable Biobankingmentioning

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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“…Recently, new European Union regulations on medical devices and in vitro diagnostic medical devices entered into force and will apply fully for in vitro diagnostics in May 2022 [1]. The requirements for in vitro diagnostics will change significantly and will also include the definition of pre-analytical parameters.…”

Section: Introductionmentioning

confidence: 99%

Pre-analytical issues in liquid biopsy – where do we stand?

Fleischhacker

Schmidt

2020

Journal of Laboratory Medicine

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It is well documented that in the chain from sample to the result in a clinical laboratory, the pre-analytical phase is the weakest and most vulnerable link. This also holds for the use and analysis of extracellular nucleic acids. In this short review, we will summarize and critically evaluate the most important steps of the pre-analytical phase, i.e. the choice of the best control population for the patients to be analyzed, the actual blood draw, the choice of tubes for blood drawing, the impact of delayed processing of blood samples, the best method for getting rid of cells and debris, the choice of matrix, i.e. plasma vs. serum vs. other body fluids, and the impact of long-term storage of cell-free liquids on the outcome. Even if the analysis of cell-free nucleic acids has already become a routine application in the area of non-invasive prenatal screening (NIPS) and in the care of cancer patients (search for resistance mutations in the EGFR gene), there are still many unresolved issues of the pre-analytical phase which need to be urgently tackled.

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Pre-analytical processes in medical diagnostics: New regulatory requirements and standards

Cited by 41 publications

References 46 publications

COVID-19: efficacy of prehospital pulse oximetry for early detection of silent hypoxemia

COVID-19: efficacy of prehospital pulse oximetry for early detection of silent hypoxemia

Recommendations for a Dutch Sustainable Biobanking Environment

Pre-analytical issues in liquid biopsy – where do we stand?

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