Standardisation of concentration measurements of extracellular vesicles for medical diagnoses

Work package 1: Development of reference materials


The aim of work package 1 (WP1) is to develop clinically relevant synthetic reference materials containing stable spherical particles with (1) concentrations in the range 109 - 1012 particle mL-1, (2) discrete diameters between 50 nm and 1,000 nm, (3) refractive index (RI) in the range 1.37 - 1.42, and (4) visible fluorescence intensity between 100 molecules of equivalent soluble fluorochromes (MESF) and 100,000 MESF.

First, we will define requirements for the reference materials based on the needs of the extracellular vesicle community and stakeholders. To reduce the risk that one particle type may not fulfil all the above requirements, three types of reference materials will be prepared: hollow organosilica beads, liposomes, and solid particles with an RI < 1.42 (low-RI solid particles). For each particle type, we will start with preparing candidate samples for method development in work package 2. Then, we will produce, distribute and study the stability of optimised samples.