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Africa: WHO Okays Two New Infant HIV Diagnostic Tests

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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 Observer (Kampala)

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