In vitro diagnostics and laboratory technology

WHO Technical Working Group Meeting on Prequalification of HIV Virological Technologies
21-23 September 2009,WHO Geneva

Life-preserving antiretroviral therapy (ART) and prevention of mother-to-child transmission of HIV programmes (PMTCT) are increasingly available in resource-limited settings (RLS). These programmes cannot function in a cost-effective manner without appropriate HIV virological testing technologies adapted to the settings of intended use. Discussions with industry have been fruitful and several manufacturers have produced newer technologies that are more suited to RLS as they are more compact, user-friendly and less prone to error. In addition, several of the virological technologies are compatible with dried blood spots enabling easier collection of specimens in rural areas and then transport for centralized testing making the technologies more accessible to the community at large. It is envisaged that procurement of HIV virological testing technologies with public funds will increase sharply in the coming years, making these types of technologies a priority for WHO prequalification.

The working group meeting organized by HSS/EHT/DLT, focused on the comparative laboratory evaluation aspect of prequalification of selected commercially available HIV virological testing technologies. The aim of the meeting was to review and select candidate technologies for prequalification, to review and finalize the WHO laboratory evaluation protocol including the operational characteristics to be assessed and its statistical validity. The meeting participants included laboratory experts on HIV virological technologies and HIV national programme managers.