Clinical requirements for extracellular vesicle assays

L Ayers, R Pink, DRF Carter… - … of extracellular vesicles, 2019 - Taylor & Francis
… such assays. It is essential to consider these parameters to ensure that we develop the highest
quality assays … to form the basis of future external quality assurance for clinical EV assays. …

Mesenchymal stem cell-derived extracellular vesicles: Progress and remaining hurdles in developing regulatory compliant quality control assays

JKE Chua, J Lim, LH Foong, CY Mok, HY Tan… - Cell Biology and …, 2022 - Springer
quality of MSC-EVs available for end use are poorly designed. Hence, in this review,
characterization of MSC-EVs and quality control … know-how in developing QC assays for MSC-EVs …

[HTML][HTML] Quality control of bacterial extracellular vesicles with total protein content assay, nanoparticles tracking analysis, and capillary electrophoresis

A Steć, J Jońca, K Waleron, M Waleron… - International Journal of …, 2022 - mdpi.com
Extracellular vesicles (EVs) were isolated from … with total protein content assay (bicinchoninic
acid assay, BCA), … of quantitation with total protein content assay and NTA. The study …

Standardization of blood collection and processing for the diagnostic use of extracellular vesicles

M Venturella, FM Carpi, D Zocco - Current Pathobiology Reports, 2019 - Springer
quality control metrics has limited the clinical validation and adoption of EV-based diagnostic
assays. … Furthermore, we suggest biochemical and molecular quality control (QC) metrics to …

[HTML][HTML] Methods for separation and characterization of extracellular vesicles: results of a worldwide survey performed by the ISEV rigor and standardization …

F Royo, C Théry, JM Falcón-Pérez, R Nieuwland… - Cells, 2020 - mdpi.com
… after stratifying for the different categories of functional assays (and none). As displayed in …
of extracellular vesicles from blood, in which the needs included education and quality control

Urinary extracellular vesicles: Assessment of pre‐analytical variables and development of a quality control with focus on transcriptomic biomarker research

K Barreiro, OP Dwivedi, S Valkonen… - … of Extracellular …, 2021 - Wiley Online Library
… Analysis of miRNAs enriched in the uEV isolates and testingExtracellular Vesicles and
urine biobanking activities, we explored the effect of basic pre-analytical variables on the quality

Functional assays to assess the therapeutic potential of extracellular vesicles

VVT Nguyen, KW Witwer, MC Verhaar… - … of Extracellular …, 2020 - Wiley Online Library
… In such cases, it may be desirable to design in vitro non-biological tests as a means of
quality control. Non-biological assays require knowledge of the MoA and allow assessment of …

[HTML][HTML] Employing flow cytometry to extracellular vesicles sample microvolume analysis and quality control

J Maia, S Batista, N Couto, AC Gregório… - Frontiers in Cell and …, 2020 - frontiersin.org
… As internal controls across assays, before each FC experiment we used two commercially
available mixes of beads (Apogee 1493 and Apogee 1517, Apogee Flow Systems, United …

[HTML][HTML] Manufacturing and characterization of extracellular vesicles from umbilical cord–derived mesenchymal stromal cells for clinical testing

E Rohde, K Pachler, M Gimona - Cytotherapy, 2019 - Elsevier
… and clinical testing, we discuss strategies of manufacturing and quality control of umbilical
… The requirements of quality control testing for biopharmaceuticals are described in detail in …

Towards IVDR‐compliance by implementing quality control steps in a quantitative extracellular vesicle‐miRNA liquid biopsy assay for response monitoring in patients …

EEE Drees, NJ Groenewegen, SAWM Verkuijlen… - 2024 - Wiley Online Library
… After the inclusion of QC steps, the accuracy of the assay was determined to … qualitycontrolled
plasma EV‐miRNA assay is technically robust, taking EV‐miRNA as liquid biopsy assay