Exosome-mediated diagnosis of human immunodeficiency virus infection

A method for monitoring the course of HIV infection in a subject, comprising:

• (a) obtaining a first urine sample removed from the subject at a first time point and a second urine sample removed from the subject at a second time point;
• (b) contacting the first urine sample and the second urine sample with a first binding agent specific for an exosomal marker, wherein the first binding agent is attached to a solid surface and captures exosomes in the first and second urine samples removed from the subject;
• (c) contacting the captured exosomes in step (h) with a second binding agent specific for an HIV protein selected from the group consisting of Nef, HIV envelope gp120, HIV protease, Vif, Pol, Gag, Gag-pol, Rev, reverse transcriptase (RT), Tat, p1, p17, Vpu, Vpr, gp41 and DNA polymerase;
• (d) measuring levels of the HIV protein in the captured exosomes in the first urine sample and the second urine sample;
• and
• (e) determining the progression of HIV infection between the first time point and the second time point based on the result of step (d).

A method for monitoring the effectiveness of treatment to a subject with an anti-HIV agent, comprising:

• (a) administering an anti-HIV agent to the subject and obtaining first and second urine samples from the subject at first and second time points relative to the administration;
• (b) contacting the first urine sample and the second urine sample with a first binding agent specific for an exosomal marker, wherein the first binding agent is attached to a solid surface and captures exosomes in the first and second urine samples;
• (c) contacting the captured exosomes in step (b) with a second binding agent specific for an HIV protein selected from the group consisting of Nef, HIV envelope gp120, HIV protease, Vif, Pol, Gag, Gag-pol, Rev, reverse transcriptase (RT), Tat, p1, p17, Vpu, Vpr, gp41 and DNA polymerase;
• (d) measuring levels of the HIV protein in the captured exosomes in the first urine sample and the second urine sample;
• and
• (e) determining the effectiveness of treatment between the first time point and the second time point based on the result of step (d).