Guidance for Manufacturers of HIV Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing
Document with specific recommendations to support a medical device licence application for HIV point of care (POC) and/or for self-testing products.
Reaching the first 90: HIV self-testing for key populations
Brief highlighting the advantages of HIV self-testing for key populations.
South Africa Pharmacy Council Minimum Standards for HIVST
Minimum standards for the selling of HIV self-test kits in South Africa.
Legal issues surrounding the distribution of HIV self-testing kits
This report presents the legal framework and human rights implications relevant to HIVST in Zimbabwe.
Market and technology landscape: HIV rapid diagnostic tests for self-testing
Third edition of the Unitaid/WHO market and technology landscape summarizes the current HIV testing gap, the challenges facing efforts to scale up, and the potential role of HIV self-testing to achieve the first 90-90-90 UN target.
European In Vitro Diagnostic Medical Devices Directives
List of essential safety, quality and performance requirements which manufacturers of IVDs must meet before being placed on the EU market.
Ban on HIV self-testing to be lifted
Health Minister, Simon Hamilton, has announced his intention to lift the restrictions on HIV self-testing in Northern Ireland
Expanding Access to HIV Self-Testing: A Market Development Approach
A market development approach aimed to identify market constraints and determine the most appropriate interventions needed to improve demand and supply as well as the enabling environment to result in an equitable and sustainable healthy market for HIVST.
Technical specifications for WHO prequalification of Human Immunodeficiency Virus (HIV) rapid diagnostic tests for professional use and/or self-testing
Statement on multiple service delivery approaches and type of assistance to implement HIVST
Target Product Profile
HIV Self-Test Version 4.1 White paper on the evaluation of current HIV rapid tests and development of core specifications for next-generation HIV tests