A PROJECT to improve the determination of levels of new HIV (human immunodeficiency virus) infections, a challenge that has presented a significant obstacle to the effective monitoring of the epidemic and the evaluation of interventions, has won a US$300,000 (UK£185,000) grant.
SeraCare Life Sciences has received a $299,771 Small Business Innovation and Research (SBIR) grant from the US National Institute of Allergy and Infectious Diseases, an agency of the National Institutes of Health (NIH).
The grant will fund the development of HIV incidence panels and a rapid test for HIV incidence.
Because individuals may have been infected for years when first diagnosed, it is difficult for epidemiologists and clinicians to distinguish between recent and longer term HIV infections.
The grant will fund development of incidence panels consisting of serial samples from donors with closely estimated infection dates. SeraCare will collect and develop commercially available samples from donors known to be very recently infected with HIV.
Along with assay technology specialist Immunetics, the new rapid HIV incidence test method will be developed using these incidence panels. The rapid test will be based on Immunetics’s patented lateral flow and detection methodology and will be the first of its kind to enable use outside of the laboratory.
A further innovation in the test device will allow the analysis of antibody titer and avidity in a single cassette. Through a licensing agreement with the US Centers for Disease Control and Prevention (CDC), the test will incorporate new HIV antigen technology developed there, which the companies say will ensure coverage of all HIV subtypes and a low rate of false recency.