According to WHO statistics on blood safety, 80 percent of the world's population has access to 20 percent of the world's safe blood supply. However, more than 40 percent (13,000,000 units) of the blood supply in the developing world is not tested for the three major transfusion-transmissible infections: human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV). Transfusion of unsafe blood accounts for 8-16 million HBV infections, 2.3-4.7 million HCV infections and 80,000-160,000 HIV infections each year. If inexpensive, rapid, improved dipsticks with sensitivity comparable to EIA were developed for blood screening, it would greatly improve the safety of the blood supply in developing countries. The overall aim of the project is to develop a rapid and sensitive diagnostic test for HIV, designated as the HIV Reflex test. The test can be used in developed countries under circumstances where an immediate result is required. For the developing countries, we propose that this test be integrated into a Triplex (HBV, IHIV and HCV) test and used as the initial step of pre-donation blood screening in high prevalence countries. The associated second step is to use the HIV Reflex diagnostic test in order to identify the agent responsible for the positive Triplex test result.
The specific aims for phase II are: 1. Production, purification and evaluation of HIV recombinant proteins. 2. Prototype dipstick development including iterative prototype testing and modification. 3. Reagent Scale up and validation. 4. Clinical evaluation for FDA approval.
