Target Product Profile: HIV Self-Test Version 4.1: A White Paper on the Evaluation of Current HIV Rapid Tests and Development of Core Specifications for Next-Generation HIV Tests

This annotated target product profile (TPP) describes the desired characteristics of an HIV self-test and is a result of a review of currently available literature, interviews with key informants/stakeholders, laboratory-generated data on the performance of rapid tests, and early usability studies in Kenya, Malawi, and South Africa. The purpose of the TPP is to provide a common foundation for the development of HIV self-tests that contains sufficient detail to allow device developers and key stakeholders to understand the characteristics a test must have to be successful.

Publication date: May 2014

Target Product Profile: HIV Self-Test Version 4.1

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