Project Lead(s): Michael Ling
Ninety-five percent of the more than 30 million people with HIV live in developing countries and major HIV tests only detect antibodies months after infection.
Quantifying HIV in plasma or viral load can aid in diagnosing acute HIV infection, determining prognosis and disease progression and aiding therapeutic monitoring.
Quantifying the viral load in plasma enables a clinician to assess the success of treatment and detect treatment failure prior to the onset of clinical symptoms.
With the Rapid and Early-detection HIV RNA Test project, GeneBio Systems Inc. sought to develop a technology to detect HIV DNA or RNA in disease specimens.
The aim was also to develop a test that would yield results in under an hour, is easy to administer and is suitable for mass-production at $1–5 cost per test.
Testing showed the synthetic HIV DNA could be detected by the DASL RAPID™ test. A manufacturing process was also developed that proved effective in distinguishing positive from negative DNA samples. A prototype kit was used to test the prototype in a clinical setting, using HIV patient blood plasma.
The developed assay could detect purified HIV RNA from patient blood plasma with an estimated 70% sensitivity and 100% specificity.
Manufacturing capability of the techniques has been established, with a process that enables long reagent stability and easy transportation for the final assay kit, especially for use in developing countries.
Regulatory contacts for current and future product development needs (ISO 13485 and cGMP manufacturing) have also been established.
Knowledge about the project has been presented at conferences and there is a patent pending on some of the techniques used or developed in the project. The firm is seeking funding to further develop this test for developing countries.