Two new innovative technologies; Alere HIV-1/2 Detect and Xpert HIV-1 Qual Assay, which provide quick infant HIV diagnostic tests, have been prequalified by the World Health Organisation.
The two diagnostic tests return results within an hour, and not weeks or months like laboratory-based systems do. They use disposable cartridges, which are pre-loaded with the chemicals needed to identify HIV in a blood sample, making them faster and easier to manage than tests that require the type of infrastructure and technical training only found in major laboratories.
Both products are being studied in some countries with a high burden of HIV to determine how and where they should be used. WHO's prequalification gives UN agencies and countries a guarantee of the tests' quality, safety and performance, and the confidence to buy and use them.
"These tests mark a significant breakthrough in our response to HIV in young children," said Mike Ward, who leads the regulation unit of WHO's Essential Medicines and Health Products department.
"They are simpler, faster, automated platforms that do not require as much infrastructure as the conventional lab-based systems and can be used at or near the point of care."
The World Health Organization said the best way to diagnose HIV infection among infants is to use tests that look for evidence of the virus in the blood, rather than those that look for antibodies or antigens. Until now, those tests required lengthy procedures conducted in a special laboratory setting needing substantial infrastructure and training.
The Xpert test runs on the same technology that is already being used to diagnose tuberculosis. To test for HIV, it only requires a change of cartridge, making it a cost-effective platform that can be used to test for multiple diseases. Xpert needs a continuous power supply but very little training or maintenance, and can be done using whole blood or dried blood spots.
The Alere platform can run on a battery for up to eight hours, making it more suitable for use in remote and rural areas where there is no laboratory infrastructure and often few skilled health workers.
In 2015, out of more than 1.2 million infants born to HIV- positive mothers globally, just over half had access to an infant diagnostic test. That's one of the reasons why only half of all children estimated to be living with HIV receive the treatment they need.
The prequalification is the result of an 18-month effort, including collaboration between WHO, South Africa's National Health Laboratory Service and the US. Centers for Disease Control and Prevention.