This Small Business Innovation Research (SBIR) Phase I project will develop method to allow for a home test to detect early (12 days post infection) and chronic HIV infection. This technology will address the lack of easily available access to private, highly accurate HIV testing that detects both early stage and chronic HIV infection. Detecting early stage infection is important because HIV is highly transmissible during this stage; however, early HIV infection is rarely detected, and thus HIV is spread unknowingly. A home test will improve access because many people find it too inconvenient or embarrassing to go to a doctor or clinic. This is especially significant given that repeated testing is necessary when risky behavior is continued. A highly accurate test that can detect early infection requires blood. However, there is no simple, rapid, painless method of drawing blood at home. If successful, this method will quickly and painlessly draw blood, integrated into a highly accurate home HIV test device.
The broader impact/commercial potential of this project is to greatly reduce the number of HIV infections in the US and worldwide. There are millions of people at risk for HIV in the US and considerably more throughout the world. the proposed kit is simple to use, inexpensive and confidential. This is important because many people with HIV don?t know it, or don't tell their partners. The impact on society could be very significant by preventing many new HIV infections. This will both reduce human suffering, and decrease government spending on AIDS. This project could also lead to additional inexpensive assays that require testing of blood and, therefore, have broad applications to many point of care (POC) testing devices. POC devices are inexpensive and accurate, allowing for the healthcare system to realize substantial savings by replacing expensive testing methods with simple POC tests at home, in emergency departments, and in primary care settings.
AIDS is an epidemic with broad reach in the United States. More than 600,000 Americans have died from AIDS, 1.2 million are currently living with HIV, and there are 50,000 new infections in the US each year. The vast majority of people infected with HIV are infected during sexual contact, with many infections being transmitted by the 20 - 25% of HIV infected people who are unaware they are infected, according to CDC estimates. Because HIV is hyperinfectious during the acute phase (which lasts approximately three months), a disproportionately large number of new infections are transmitted by individuals who have been infected for less than three months. To address this early transmission problem, blood tests have been developed that can detect HIV within about two weeks of infection. Such tests are only available at healthcare facilities such as HIV testing centers, doctor’s offices and hospitals. However, HIV infected people are rarely tested in this early phase due primarily to the inconvenience of visiting such centers – an inconvenience that is heightened by the fact that frequent repeat testing is necessary in order to be likely to detect a newly acquired HIV infection as soon as it becomes detectable (as early as 12 days post infection). Concern about privacy is another reason people are reluctant to get tested at testing centers. To address this unmet need, we are developing a painless, one piece, one step rapid home HIV blood test device that will allow the consumer to test for early as well as longer standing HIV infection. Blood is the only current sample type that will allow for the required sensitivity of the assay. As mentioned above, appropriate assays for early detection of HIV are available; however, a safe and simple method for drawing blood is missing. Our goal is to develop a painless method of obtaining blood. In the course of a 6-month study, we demonstrated that it is feasible to painlessly draw the amount of blood required to run the test, and automatically transfer this blood to a test strip. Our next steps will be to optimize and then test the device for FDA approval as a rapid point of care diagnostic test for early and longer standing HIV infection.
