
| Health topic | HIV/AIDS |
|---|---|
| Classification | Diagnosis |
| Scope | Clinical trial |
| Manufacturer location |
London, United Kingdom |
The vast majority of patients needing diagnosis and treatment for HIV infection live in rural areas of developing countries. There is a need for a CD4 counter that does not require a laboratory or expensive equipment. The test will assist healthcare workers in district hospitals and health centers of developing countries to make clinical decisions in the management of antiretroviral therapy.
The CD4 Initiative Test is a rapid and robust, point-of-care diagnostic to count CD4 T cells in adults living with HIV or AIDS in resource-poor countries. Specifically designed to be used in peripheral health centers, the test will be used to aid diagnosis of HIV or AIDS patients as well as for the initiation of antiretroviral therapy. The test is a single, disposable unit which can deliver an absolute CD4 count without complex electronics and instrumentation, ensuring that it is most suitable for resource-poor countries.
For more manufacturing information: The CD4 Initiative
Field trials were completed in the UK and clinical trials began in Malawi and Uganda in 2010.
The Bill and Melinda Gates Foundation
Zachariah, R., Reid, S. D., Chaillet, P., Massaquoi, M., Schouten, E. J., & Harries, A. D. (2011). Viewpoint: Why do we need a point-of-care CD4 test for low-income countries? Tropical Medicine & International Health, 16(1), 37-41.
Imperial College London. (2011.) CD4 Initiative: How it works. Link found here.
Zyomyx, Inc. (2009.) Zomyx point-of-care CD4 test selected by CD4 Initiative to help treat HIV/AIDS patients in developing countries. Link found here.
| Authors | Lonny Grafman, Chris Waterguy, Emilio, Kathleen Sienko, Amir Sabet Sarvestani |
|---|---|
| License | CC-BY-SA-3.0 |
| Organizations | Appropedia Foundation, University of Michigan |
| Cite as | Evashiu (2012–2026). "Global Health Medical Device Compendium/CD4 Initiative Test". Appropedia. Retrieved September 30, 2026. |