22 June 2016

Africa: WHO Okays Two New Infant HIV Diagnostic Tests

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.



Real Madrid Win Third Straight Champions League Title

Gareth Bale came off the bench to help Real Madrid win an historic third Champions League in a night full of drama in… Read more »

See What Everyone is Watching

Copyright © 2016 The Observer. All rights reserved. Distributed by AllAfrica Global Media (allAfrica.com). To contact the copyright holder directly for corrections — or for permission to republish or make other authorized use of this material, click here.

AllAfrica publishes around 800 reports a day from more than 140 news organizations and over 500 other institutions and individuals, representing a diversity of positions on every topic. We publish news and views ranging from vigorous opponents of governments to government publications and spokespersons. Publishers named above each report are responsible for their own content, which AllAfrica does not have the legal right to edit or correct.

Articles and commentaries that identify allAfrica.com as the publisher are produced or commissioned by AllAfrica. To address comments or complaints, please Contact us.