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CD4 Initiative Test

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This Global Health Medical Device is designed for or implemented within resource-limited settings - Browse the devices - Add a device

Cd4initiative test.png
Health Topic HIV/AIDS
Classification Diagnosis
Scope Clinical trial
Location Africa

Problem being addressed[edit]

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.

Detailed description of the solution[edit]

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.

Designed by[edit]

  • Designed and manufactured by: Zyomyx Inc and ImmunoSite Technologies LLC

For more manufacturing information: The CD4 Initiative

  • Address: 2nd Floor, Institute for Global Health, Imperial College London, 15 Princes Gardens, South Kensington, London UK, SW7 1NA

When and where it was tested/implemented[edit]

Field trials were completed in the UK and clinical trials began in Malawi and Uganda in 2010.

Funding Source[edit]

The Bill and Melinda Gates Foundation


Peer-reviewed publication[edit]

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.

Other internally generated reports[edit]

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.