Risk assessment for therapeutic drugs

A method for assessing risks associated with human immune responses against therapeutic drugs, the method comprising:

• a. Contacting a biological sample from a human subject with a portable device capable of testing for human anti-drug antibodies (ADAs) against one or more therapeutic drugs, wherein labeled entities are immobilized on the portable device, wherein said labeled entities on said device can bind to a constant region of the human ADAs and wherein the labeled entities bound to ADAs complex flow towards to one or more capture reagent immobilized on the device, and wherein the capture reagent comprises said therapeutic drugs or regions of said therapeutic drugs;
• b. Detecting a visible signal resulting from binding of ADAs from step (a) to one or more therapeutic drugs or regions of said therapeutic drugs immobilized on the device;
• and
• c. Correlating signal from step (b) with presence or absence of ADAs.