Point of Care HIV Diagnostics
Partnership with UNITAID and Clinton Health Access Initiative
Access to HIV diagnostics to determine HIV infection is one of the major bottlenecks to timely treatment initiation in children and adults. Diagnostics for early infant diagnosis (EID) and viral load (VL) screening to monitor viral suppression have been historically offered using complex technologies, requiring test results to be sent away to central laboratories. Some HIV positive clients can wait for weeks or even months to receive test results, causing delays in treatment initiation.
In November 2012, Clinton Health Access Initiative (CHAI) and UNICEF, with funding from UNITAID, launched a project to accelerate access to innovative point of care (POC) diagnostics. The project aims to expand access to HIV diagnostics, complementing conventional laboratory platforms with simplified technologies that can be used at lower levels of care.
The goal of the project is to speed clinical decision-making by reducing turn-around time for test results. It will be accomplished by scaling up POC products while strengthening the existing conventional HIV diagnostics programs in seven high burden countries, namely Ethiopia, Kenya, Malawi, Mozambique, Tanzania, Uganda, and Zimbabwe.
Beyond the direct public health impact of improving testing services in these countries, the project will also have an impact on markets. This will drive demand and lower costs to ensure that testing sites have access to high quality, affordable point-of-care HIV diagnostics.
In the seven target countries, experiences with POC CD4 indicate that POC testing can substantially reduce turnaround time for test results. By enabling same-day ART initiation, POC testing has been shown to reduce patient loss to follow up and dramatically increase the rate of ART initiation. POC technologies for EID and VL testing are expected to have similar impacts, with the likelihood of improving timeliness in clinical decision making in delivery of HIV care and treatment, impacting on quality of care.
Currently there are two POC EID products (Alere Q and Cepheid) and one POC VL product (Cepheid) that that are being evaluated POC project countries (Kenya, Mozambique, Tanzania and Zimbabwe) and more are expected to be available before the end of 2016.