Access to point-of-care tests for people with advanced HIV under threat as diagnostics corporations to stop production

MSF calls on US based corporations Abbott and BD to ensure adequate supply of CD4 tests and equipment 

Geneva, 11 May 2023 – In a new report released today, Médecins Sans Frontières/Doctors Without Borders (MSF) warned that access to point-of-care CD4 testing for HIV is under threat because US diagnostics corporations Abbott Laboratories (Abbott) and Becton Dickinson (BD) have decided to stop making crucial equipment to run CD4 tests. This business decision was made in response to decreasing demand for CD4 tests after the World Health Organization (WHO) guidelines recommended switching from CD4 to viral load testing for HIV treatment monitoring, but CD4 testing remains an essential component of managing care for people with advanced HIV, and therefore production of these tests remains critically needed.  

To safeguard access to lifesaving CD4 testing, MSF called on Abbott and BD to immediately reverse their decision to stop the production of CD4 equipment or transfer the technology to a manufacturer in a low- or middle-income country (LMIC) and support local production. In addition, we encourage the WHO to provide updated and explicit guidelines about the critical role of point-of-care CD4 testing. 

HIV infects and destroys CD4 cells, which are a type of white blood cell that play a key role in the human immune system. CD4 tests count the number of CD4 cells in a blood sample: a low CD4 cell count indicates advanced HIV disease. Up to 30% of people beginning HIV treatment are diagnosed with advanced HIV disease, which requires immediate and specific medical care as the risk of death is high. CD4 tests can be carried out through large, laboratory-based devices or point-of-care devices. Point-of-care CD4 devices are battery-powered equipment or disposable rapid tests that require minimal or no laboratory infrastructure, making them especially useful in decentralised and low-resource settings.   

“We rely on CD4 testing to diagnose advanced HIV disease in people living with HIV: it’s an essential and often lifesaving step toward providing each person in our care with the appropriate tools to manage their disease,” said Dr Fabien Kabongo, Medical Coordinator for MSF in Conakry, Guinea. “Point-of-care CD4 tests are a particularly crucial diagnostic tool in the communities where we work, as we can bring the tests to people to diagnose advanced HIV disease. It’s therefore vital that the WHO guidelines clarify that there is still a critical role for point-of-care CD4 tests so that people living with HIV can receive the right package of care as soon as possible.” 

Approximately 8 million CD4 tests are needed annually in LMICs: Abbott’s and BD’s decisions to stop producing CD4 testing devices will significantly impact the provision of care to people with HIV in low-resource settings, including in HIV programmes run by MSF. 

“Abbott and BD’s decision to stop making critical point-of-care testing equipment for HIV is going to have a major negative impact on the lives of people with advanced HIV,” said Stijn Deborggraeve, Diagnostics Advisor, MSF Access Campaign. “Abbott and BD need to urgently restore production of the point-of-care CD4 testing equipment, and governments should act fast to expand the use of CD4 testing in-country to save lives from advanced HIV disease.” 

MSF report, “Make It Count: Access to Point-of-Care CD4 Testing Under Threat,” provides a deeper analysis on access to lifesaving point-of-care CD4 technologies.

For interviews, please contact Morag McKenzie, Morag.McKENZIE@berlin.msf.org, +49 172 525 1319