Abstract

The Difficult First Step for POC Diagnostics

Paul Yager, Professor/Vice Chair, University of Washington

A diagnostic process, no matter how long, begins with a first step.  Whether to guide treatment of an individual’s infection, or to control the outbreak of a pandemic, there is an urgent need for low-cost rapid diagnostic devices capable of identifying the cause of infectious disease that work wherever the person is, not just in a centralized laboratory.  “Ubiquitous diagnostics” can bring the best diagnostic capabilities to homes, physicians’ office laboratories and pharmacies in the developed world, or to places in the developing world where nothing is available now.  However, the greatest challenge is often not detection of the analyte(s), but the preparation for the sample for that detection process.  Samples differ in volumes, the concentration of the analyte, and the presence of components that can interfere with analyte detection.  We have been working to develop simple devices for nucleic acid amplification tests (NAATs) for the presence of Chlamydia and gonorrhea, Mycobacterium tuberculosis and HIV.  To enable them we have created a suite of stand-alone or integrated sample-handling components that can process blood, urine or swabs from different cavities in the body: the goal in all cases is to create a few microliters of a fluid that is both concentrated and “clean” enough that it can be introduced automatically into a sensitive NAAT device of our own design.  We will show recent progress in reducing such processes to a few user-friendly steps appropriate for untrained users.