In developed countries, we don't understand how prevalent HIV is.  In some areas of sub-Saharan Africa, up to one third of the adult population are HIV positive which means many infants are exposed to HIV.  Infants can not be tested with standard HIV antibody tests because HIV positive mothers always pass their antibodies to the child, but not necessarily the actual virus.  This means testing must either detect the actual virus with nucleic acid testing (expensive, complicated) or with a test that detects something associated with the protein.  We opted for the latter.  

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The kit consists of a lateral flow test strip, a unit dose with running buffer, a plasma separation, and off-the-shelf components to conduct the test.  The plasma separator is necessary because centrifuges and the skills to use them are unavailable in the smallest clinics served by this test.  We designed and tested all the components (consumable and device), manufactured and tested, identified production suppliers and field tested the systems.  

This system proved to be nearly as sensitive as nucleic acid testing in lab trials and approximately as sensitive as the adult HIV testing in the field.  Clinical trials are on-going in Zambia.

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This project was done at Northwestern University with funding from Northwestern Global Health Foundation and assistance from Westberg Innovation and Silicon Engines.