WHO Informal Consultation on Specifications and Validation on HIV/AIDS Diagnostic Technologies
12-14 September 2005, held in Geneva.
An informal consultation focussed on the specifications and validation of HIV/AIDS diagnostic technologies took place from 12-14 September at WHO in Geneva. The meeting bought together laboratory and regulatory authority experts from all over the globe.
Access to HIV/AIDS treatment and care programmes is now widening for resource-limited settings. The need for high quality test kits and appropriate testing practices with affordable diagnostic equipment in good laboratories is even more important than ever before. Faulty test kits and substandard technologies could result in the wrong treatment being prescribed. This leads to ineffective therapy and increases the potential for drug resistance.
Most developing countries do not have fully developed regulatory bodies overseeing the quality and efficacy of tests to aid the diagnosis and clinical monitoring of HIV/AIDS. Sophisticated techniques for laboratory monitoring of patients under treatment and also newer, easier to use technologies such as HIV rapid tests all require consideration of their quality.
There is a burgeoning number of new manufacturers and distributors of HIV rapid test kits and other diagnostic technologies. They operate in countries with weak regulations, which further poses potential problems for overall quality of HIV diagnosis.
Since 1988, WHO has coordinated a test kit evaluation programme to assess and evaluate commercially available serological test kits. The programme provides guidance and specifications for laboratory testing and monitoring, with more emphasis lately on CD4 enumeration and viral load determination technologies.
UN procurement agencies, non-governmental organizations, the Global Fund to fight AIDS, TB, and Malaria, the Clinton Foundation and countries increasingly rely on the guidance provided by WHO on diagnostics and equipment that have been evaluated and intend to bulk purchase products at reduced prices.
Some buyers currently have little information on sources, prices and regulatory status of quality HIV diagnostics. Listing of successfully evaluated diagnostics and equipment on the WHO Bulk Procurement Scheme is a valuable service to procurers, specifically those at country level, and assists them to make informed choices.
In particular, the meeting sought the consensus among the wide range of stakeholders on the minimum specifications and validation criteria to assure reliable HIV/AIDS related diagnostic technologies. Agreement on the best strategies to ensure that diagnostics are affordable for countries with a high HIV/AIDS burden but with limited resources was an outcome of great importance.