The World Health Organization (WHO) has prequalified two innovative technologies for early diagnosis of HIV in infants.

Background information:

Prequalification: A process of evaluation undertaken by the WHO Prequalification Programme (PQP). In essence, the programme invites manufacturers to submit their product(s)- diagnostic tests, vaccines and medicines- for assessment by the PQP. The products are evaluated against a set of stringent criteria, and certified appropriately.

Prequalification status indicates that the product meets a certain standard, and usually purchases within the UN institutions are limited to products featuring on the prequalification list.

WHO prequalification gives UN agencies and countries a guarantee of the tests’ quality, safety and performance, and the confidence to buy and use them.

Disclaimer: Please read the WHO disclaimer for prequalified diagnostic products: http://www.who.int/diagnostics_laboratory/evaluations/disclaimer/en/

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.

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.

Key Messages:

The two 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 HIV in infants in as little as an hour.

Both employ Nucleic Acid Testing (NAT), but have different operational requirements and functional capabilities.

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.

Both tests use disposable cartridges which are pre-loaded with the chemicals needed to identify HIV in a blood sample.

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.

Useful Links:

Link to the WHO news release:

http://who.int/diagnostics_laboratory/cutting-edge-hiv-prequal/en/

Link to WHO’s list of prequalified in vitro diagnostic products:

http://www.who.int/diagnostics_laboratory/evaluations/160620_prequalified_product_list.pdf?ua=1