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Point-of-care HIV early infant diagnosis: is test sensitivity everything?
Lorna Dunning1, Nei-yuan Hsiao2, Landon Myer1,3
1Division of Epidemiology & Biostatistics, School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa.
Insights
Early infant HIV diagnosis (EID) point-of-care tests can improve linkage to antiretroviral therapy (ART) services, even with suboptimal sensitivity. Focusing on health system integration is key for successful EID programs in sub-Saharan Africa.
Area of Science:
- Public Health
- Infectious Diseases
- Health Systems Research
Background:
- Despite PMTCT improvements, sub-Saharan Africa still sees nearly 200,000 annual pediatric HIV infections.
- Current early infant HIV diagnosis (EID) relies on centralized labs, limiting access in low-resource settings.
- Point-of-care (POC) EID tests offer potential to increase access and improve infant retention in care.
Purpose of the Study:
- To evaluate the integrated performance of POC EID tests, considering both clinical and health system factors.
- To determine if improved linkage to care can compensate for potential sensitivity limitations of POC EID tests.
- To shift EID program focus from solely test performance to successful linkage to antiretroviral therapy (ART).
Main Methods:
- The study proposes a framework for evaluating POC EID tests that integrates performance characteristics with health system considerations.
- It models the impact of improved linkage to care on overall EID program effectiveness.
- The research emphasizes the need to explore implementation and operational aspects of new POC technologies.
Main Results:
- Moderate improvements in linkage to care can significantly offset suboptimal sensitivity of POC EID tests.
- The ability of POC EID tests to facilitate linkage to ART services is a critical program management factor.
- Focusing on health system integration is crucial for realizing the full benefits of POC EID technologies.
Conclusions:
- POC EID tests have the potential to enhance early infant HIV diagnosis programs in resource-limited settings.
- Successful implementation requires a focus on health system integration and linkage to ART services, not just test sensitivity.
- Further research into the operational aspects of emerging POC EID tests is urgently needed to maximize their public health impact.
Abstract:
Despite improvements in PMTCT services in low- and middle-income countries, there are still almost 200,000 new paediatric HIV infections annually in sub-Saharan Africa. This has led to early infant HIV diagnosis (EID) programmes becoming a public health priority, but until recently, EID has required specialist laboratory equipment and trained personnel which is only feasible in urban, centralized facilities. It is thought that the successful implementation of a point-of-care (POC) test for EID has the potential to increase access to virological tests and address some of the barriers regarding retention of infants in care. However, POC evaluation has not integrated focus on performance characteristics with the health systems issues surrounding the adoption of and optimum use of these new technologies. We propose that moderate improvements in linkage to care can more than offset suboptimal sensitivity of a POC EID test which could be critical in adjusting the focus for EID programme management away from test performance and towards their ability to facilitate successful linkage to antiretroviral therapy (ART) services. These findings also highlight the urgent need to explore the implementation and operational aspects of emerging POC tests in order to fully realize the potential benefits of new technologies in practice.

