August 6, 2013 -- On 13 July, the joint United Nations programme on HIV/Aids (UNAids) announced their ambition to provide anti-retroviral therapy (ART) to 15 million people infected with HIV/Aids by 2015 (up from a total of 9.7 million in 2012). The new framework was published on the back of new WHO guidelines that recommended that patients start treatment earlier.
More specifically, the guidelines raised the threshold of the CD4 count at which ART should be prescribed from 350 cells/mm3 of blood to 500 cells/mm3. CD4 cells are the white blood cells attacked by the HIV virus; their count provides an indication of the state of an individual's immune system and the progression of the disease.
CD4 counts are therefore pivotal to reach the UNAids target, particularly in sub-Saharan Africa where HIV prevalence is high, but the test isn't widely available in countries with poor health care.
In Malawi for instance, only 10% of health facilities offer CD4 counts. The situation is much the same elsewhere on the continent and millions of people are waiting for their CD4 count.
The introduction of decentralised point-of-care tests, which can be used in resource-constrained settings by low-skilled health workers, could significantly increase coverage. In Mozambique, the introduction of point-of-care CD4 counts in primary healthcare clinics doubled the number of patients on ART and halved the time it took for patients to start treatment.
The trouble is that such point-of-care diagnostics are something of a blind spot when it comes to regulation. "We have a very good regulatory framework for drugs but there is a vacuum for diagnostics," says Ilesh Jani, director of the Instituto Nacional de Saúde (National Health Service) in Mozambique. "There is a registration for diagnostics, similar to drugs, but it does not really do a good regulatory function."
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