Affinity capture of extracellular matrix bodies

A process for separating, isolating or enriching extracellular matrix bodies in a biological fluid, the process comprising capturing the extracellular matrix bodies on a substrate, optionally wherein:

• a) the substrate is:
• i) a solid and comprises one or more immobilized capture moieties for binding and immobilizing the extracellular matrix bodies;
• ii) of any shape in the form of a bead, a gel, a magnetic bead, a paramagnetic bead, a plate, a well, a membrane, a particle, a sheet, or a fiber;
• and/or
• iii) composed of an inorganic material, a polymeric material, an organic material, a metal, a glass, or a combination thereof;
• b) the capturing comprises:
• i) contacting the biological fluid with the substrate;
• and/or
• ii) adding capture moieties to the biological fluid and contacting the biological fluid with the substrate;
• c) the biological fluid is:
• i) incubated with the substrate, and wherein the substrate comprises capture moieties;
• and/or
• ii) the biological fluid is processed before the capturing on the substrate to remove cells and cell debris;
• and/or
• d) the process further comprises:
• i) washing the substrate to remove the biological fluid and any non-bound components from the substrate;
• ii) eluting the immobilized extracellular matrix bodies from the substrate, wherein the extracellular matrix bodies have a principal size from about 1 micrometer to 200 micrometers, or from about 4 micrometers to 200 micrometers;
• and/or
• iii) tagging the extracellular matrix bodies in the biological fluid for capturing on the substrate, optionally wherein the tagging uses epitope tags, affinity tags, fluorescent tags, or a combination thereof.

A process for diagnosing, prognosing or monitoring a disease in a subject, the process comprising:

• a) separating, isolating or enriching extracellular matrix bodies in a biological fluid sample of the subject, wherein the separation, isolation or enrichment involves capturing the extracellular matrix bodies on a substrate;
• b) determining a level of one or more biomarkers based on the separated, isolated or enriched extracellular matrix bodies, wherein the biomarker is the level of the extracellular matrix bodies, or the level of a substance found in the extracellular matrix bodies, wherein the substance is a protein, a polypeptide, a lipid molecule, a lipoparticle, a carbohydrate, a nucleic acid molecule, or an expression level of a nucleic acid;
• and
• c) comparing the level of the biomarkers to a reference level based on a control group of subjects, and diagnosing, prognosing or monitoring the disease in the subject.