This disclosure provides a method to capture, detect, characterize and quantify human exosomes in small volumes of
human body fluids by using a sandwich
ELISA test. This method allows a full characterization of an
exosome preparation, thus providing a tool to distinguish a
disease-related condition from a healthy state, by the use of a non-invasive
assay. In fact, this method may be useful in screening, diagnosis and prognosis of tumors, with a simple
plasma sample. At the same time measurement of circulating exosomes may provide information on the level of tumor
mass present in a patient. The method provided here is suitable to evaluate presence of some infectious and / or transmissible agents, such as viral proteins or
prion proteins, within circulating exosomes.