Accelerate Access to Innovative Point of Care (POC) HIV Diagnostics: CD4, EID and VL
Despite the progress that has been made in recent years in the fight against HIV/AIDS, there are still 1.8 million AIDS-related deaths and 2.7 million new infections every year. Access to HIV prevention and treatment has improved significantly in the last few years, but major gaps remain between need and access. There are still several obstacles to effective initiation and management of antiretroviral therapy (ART) for HIV/AIDS. For example, limited access to diagnostic tests in resource-limited settings leads to poorer health outcomes, higher treatment costs, and further spread of diseases.
Three main obstacles to opportune initiation and appropriate management of treatment are:
- Late initiation in adults due to limited access to CD4 testing, which determines ART eligibility
- Late initiation in infants due to limited access to Early Infant Diagnosis (EID) testing, which determines HIV status of the child
- Late switching to second line treatment due to limited access to Viral Load (VL) testing, which identifies first line treatment failure
The existing global market for HIV diagnostics does not meet the needs of the 34 million people living with HIV. The sophisticated technologies that are dominating the market are ill-suited to most resource-limited settings:
- They are expensive
- They require complex laboratory infrastructure, stable electricity supply, and highly trained laboratory technicians
- They have limited geographical access.
Consequently, the coverage for HIV diagnostic testing remains low (61% for CD4, 26% for EID and 25% for VL), even as demand for HIV testing grows and ART programmes are scaled up.
The overarching goals of the project are to:
- Enable earlier initiation of patients onto life-saving antiretroviral therapies
- Facilitate timelier switching of patients onto more effective second line antiretroviral therapy regimens by reducing loss to follow-up and test turn-around time
- Accelerate global access to a new generation of high-quality HIV diagnostic products at the point of care
- Create a healthy, dynamic and sustainable market with affordable prices for these products
This should ultimately reduce mortality from HIV/AIDS and improve patient outcomes.
HIV 'Point of Care' (POC) technologies can be transported and operated by non-laboratory technicians at the community level in the health system. This will enable:
- Increased access to diagnostic tests, and HIV prevention and treatment centers
- Decreased loss to follow-up amongst patients
- No or minimal training requirements
- Much faster test results
- Potentially lower prices per test
This should ultimately improve equity by reaching all vulnerable groups.
The project focuses on the following HIV POC technologies:
CD4: testing, which is used for staging and monitoring HIV patients prior to initiation onto antiretroviral therapy (ART)
Early Infant Diagnosis (EID): testing for infants less than 18 months of age (this technology can be performed on viral load platforms)
Viral Load (VL): testing, which is mainly used for monitoring HIV patients following initiation to ART
PHASE 1 SUMMARY
Request of Expression of Interest (2012):
UNICEF, CHAI and UNITAID launched a 'Request for Expression of Interest' (REoI) at the end of 2012, targeted at industry, academia and others engaged in the development of point of care products. This invited them to express their interest in becoming a future supplier of these product categories, and to provide information about their existing and future products, including instruments, reagents, consumables, and after-sale support.
RFP for Field Evaluation (2013):
UNICEF, in partnership with Médecins Sans Frontières (MSF), opened in October 2013 a joint Request for Proposal (RFP) to the industry engaged in the development of POC products for CD4, EID and VL. The purpose of the tender was to identify and procure, based on countries’ requests, limited quantities of the new PoC technologies for field evaluation purposes. Its outcome revealed there are several innovative technologies that could facilitate treatment initiation and monitoring at the POC level.
HIV PoC/near PoC equipment can be strategically placed and used at the primary and secondary levels of the health system. This could depend on:
Reagent stability (required refrigeration or not)
Instrument weight (portable vs bench top)
The need for additional equipment (e.g. a centrifuge)
The following graph describes the strengths and weaknesses of the HIV POC / near POC technology according to health system level: