In vitro diagnostics and laboratory technology

WHO Technical Working Group on Statistical Approaches for Development and Validation of HIV Incidence Assays, 22-24 April 2009,WHO Geneva

There have been considerable efforts made to develop HIV assays in order to detect recently-acquired HIV infection. Such assays would have three testing objectives: 1) detection of recent HIV infection at the individual level; 2) estimation of the incidence of HIV infection at a population level; and 3) utilization in clinical trials of interventions.

However, the assay development pathway for HIV incidence assays has yet to be rigorously defined. The statistical approaches for each testing objective still need to be clarified, as each population may have different characteristics. Understanding the dynamics of HIV incidence in these different populations will assist in ensuring the accuracy of different HIV incidence assays.

Since 2006, WHO has been organizing a series of formal and informal meetings to discuss efforts towards global guidance on assays for HIV incidence. Much work has been completed towards a common validation protocol to assess and compare the performance of assays. A subgroup of the WHO Technical Working Group on HIV Incidence Assays met in Geneva on 22-24 April 2009 to reach consensus on the necessary statistical approaches required to optimize existing or future HIV incidence assays.

The meeting was a cross-cluster and inter-department event that was jointly organized by HSS/EHT/DLT and HTM/HIV/SIR. The outcomes will contribute to the wider discussion on the application of HIV incidence assays.

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