WHO Prequalification for Two HIV Detection Technologies in Infants

Two new technologies that can test an infant for HIV infection within an hour, has received WHO prequalification. With this technology, instead of sending a sample to a laboratory, that can take weeks or even months to return, the test can now be done within an hour and the infant placed on life-saving treatment much earlier.

The groundbreaking products are Alere™ q HIV-1/2 Detect (made by Alere Technologies GmbH) and Xpert® HIV-1 Qual Assay (made by Cepheid AB).

Currently only half of infants living with HIV have access to the correct treatment. The tests used to diagnose HIV among infants involve lengthy procedures and special laboratories settings, which comprise of considerable infrastructure and training. With these new technologies, this process has been simplified allowing for more infants to be tested, with quicker results.

Both products are currently being studied in countries with a high HIV infection level. What WHO prequalification means to these countries is that the quality, safety and performance of the tests are guaranteed. Both the tests are disposable units pre-loaded with chemicals that are required to detect HIV in a blood sample.

Mark Ward, head of the regulation unit of WHO’s Essential Medicines and Health Products department, commented the following; “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.”

“Using at or near-point of care technologies for early infant diagnosis of HIV has the potential to bring the test closer to the mother-infant pair and ultimately save the lives of children,” said Gottfried Hirnschall, Director of WHO’s Department of HIV.

One of the main differences between the two products is that the Xpert test requires a constant power supply and the Alere test runs on battery power. The Xpert test can be done by using dried blood spots or whole blood, and requires very little maintenance or training. Alere is more suitable for use in rural and isolated areas where there are very few trained health workers and no laboratories.

For more information on this, please go to: http://www.who.int/diagnostics_laboratory/cutting-edge-hiv-prequal/en/