‘Cutting-edge technologies diagnose HIV in infants within one hour’
At last, many more infants could be diagnosed quickly of Human Immuno-deficiency Virus (HIV) and placed on life-saving treatment following the prequalified of two innovative technologies for early infant by the World Health Organisation (WHO).
The WHO in a statement, on Monday, said the products, Alere™ q HIV-1/2 Detect (made by Alere Technologies GmbH) and Xpert® HIV-1 Qual Assay (made by Cepheid AB) can be used to diagnose infants in as little as an hour, instead of sending a sample to a laboratory, which can take weeks or months to return a result.
Both products are being studied in some countries with a high burden of HIV to determine how and where they should be used. WHO prequalification gives UN agencies and countries a guarantee of the tests’ quality, safety and performance, and the confidence to buy and use them.
Both tests use disposable cartridges, which are pre-loaded with the chemicals needed to identify HIV in a blood sample. That means they are faster, smaller and easier to manage than other tests that require the type of infrastructure and technical training that is typically only found in major laboratories.
The Xpert® test runs on the same technology that is already being used to diagnose tuberculosis. To test for HIV, it merely 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.
According to the WHO, 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 is one of the reasons why only half of all children estimated to be living with HIV receive the treatment they need.
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. These new technologies have simplified these procedures allowing for more infants to be tested, with faster results.
Mike Ward, who leads the regulation unit of WHO’s Essential Medicines and Health Products department, said: “These tests mark a significant breakthrough in our response to HIV in young children. 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.”