SBIR Phase I: Microneedle Based Home Blood Test for Early HIV Detection

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.