Seminar #38

Regulation of HIVST in Africa: requirements, readiness and response

Hosted by: STAR/WITS

No invitations necessary; open to all conference registrants

Wednesday, 7 December
CTICC room location: 2.6

Medical Scientists, IVD regulators, HIV policy makers

Many countries in Africa are now focusing on the regulation of in-vitro diagnostics (IVDs) as well as investigating the implementation of HIV self-testing in hard to reach populations. This session will provide an update on current projects and research focusing on the regulation of HIV self-testing. The unique issues for regulators and policymakers for the regulation of HIV self-testing will be highlighted. Lessons learned and challenges faced from current projects will be shared and discussed with participants. The session will also update participants on the current regional IVD regulator harmonization efforts in Africa.


  • Determine the regulatory requirements for HIV self testing
  • Be aware of potential challenges in the regulation of HIV self testing


Anita Sands, World Health Organization
Dr. Sands works in the WHO Prequalification Team – Diagnostics Assessment. She has responsibility for facilitating prequalification activities for IVDs (dossier assessments, inspections and laboratory evaluation), and post-market surveillance of IVDs through complaint handling and lot verification testing. She provides technical support to countries for implementation of testing services for bloodborne viruses (HIV, HCV, HBV, etc.) including product selection, quality assurance and procurement, with a particular emphasis on resource-limited settings.

Mohammed Majam, WITS Reproductive Health Institute
Mohammed is a Senior Programme Manager at the Wits Reproductive Health and HIV Institute. He heads the organisations HIV Self-Testing Programme which has various portfolios. His research focuses primarily on Self-Test Usability and test performance in target populations. Along with Professor Francois Venter, he is also heading the South African HIV Self-Testing Guidance Development Group.

Russell Dacombe, LSTM
Russell has primarily worked in the improvement of diagnostic capacity in developing countries for over 15 years focusing on improving the quality of results at all levels of health care. As part of this work he has been involved in determining the barriers in health systems to deploying diagnostic tests effectively, including HIV. He is currently involved in a project looking at how best to regulate HIV self tests in Africa and how to monitor there performance in the hands of intended users.