Post-Market Surveillance for HIV Self-Testing
Sponsors: World Health Organization
Date: Tuesday, 11 December 2018
No invitations necessary; open to all conference registrants
Policy makers, programme managers and IVD manufacturers
The WHO’s Department of Essential Medicines and Health Products supports end-users, including HIV self-testers, to conduct post-market surveillance of in vitro diagnostics (IVDs).
Post-market surveillance of IVDs is the action of detecting, investigating, and acting on any issue related to the safety or quality of performance of an IVD after it has been placed on the market. Common complaints that should be reported for HIV IVDs for self-testing include:
- False-negative test results,
- False-positive test results,
- Invalid results (when neither a reactive or non-reactive result can be read), and
- Defective or missing reagents/consumables that mean the IVD cannot be used.
Complaints should be reported back to the location where the HIV self-test was distributed (e.g., pharmacy, health clinic). These complaints are then reported back to the IVD manufacturer for their investigation and corrective action, if needed.
Who should attend?
Testing providers (end-users, including HIV self-testers) and manufacturers of IVDs.
What will you learn?
- How to use WHO guidance on post-market surveillance of IVDs for HIV self-testing.
- How to report complaints for HIV IVDs used for self-testing.