Skip navigation.

WHO/UNITAID Landscape for HIV Rapid Tests for HIV Self-Testing

Publication year: 
Corporate author: 
Publication details: 
Geneva, WHO, 2015

This report presents the potential for HIV self-testing to contribute to achieving global 90–90–90 targets for treatment access by 2020 (1), provides projections of the demand for and supply of HIV rapd diagnostic tests (RDTs) for self-testing and summarizes the emerging market landscape for self-testing. This information will likely be useful for manufacturers, donors, national programmes, researchers and many other global health stakeholders who are exploring the potential role of HIV self-testing.

The projections and estimates rely on data from a number of sources. The projected demand for HIV RDTsfor professional use are based on the World Health Organization (WHO) forecast (2) that is based on the number of HIV testing events reported through the Global AIDS Response Progress Reporting (GARPR) and the number of HIV RDTs procured for professional use reported through the WHO Global Price Reporting Mechanism (GPRM) and Supply Chain Management System (SCMS). The projected demand for HIV RDTs for self-testing is based on a model using the current forecast for professional-use RDTs and applying various scenarios derived from existing literature and research on the use of HIV self-testing.

The information on the market of HIV RDTs for professional use, as well as how many are procured and at what price base, is based on reports from the WHO prequalification of In Vitro Diagnostics (IVDs) Programme and the UNITAID and the Price and Quality Reporting (PQR) mechanism from the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund). The estimated price and procurement of HIV RDTs for self-testing was based on manufacturer reports and were limited to products with approval from a stringent regulatory authority, defined as founding members of the Global Harmonization Task Force (GHTF).

A summary of the approval pathway for HIV RDTs for both professional use and self-testing is provided.