Keywords: CD4; flow cytometry; training; external quality assurance; HIV; T lymphocytes
The object of the project is to expand the current European EQA system for lymphocyte subset analysis that was developed within the Fifth Framework Programme (FP5) project (QLRI-CT-2000-00436). This will also be underpinned by the project providing global training support of the flow cytometric enumeration of CD4+T lymphocytes, essential in the international efforts of monitoring generic anti-retroviral HIV therapy and vaccine trials. Two major international conferences are also planned that will serve to disseminate the project outcomes and help assist in establishing the EQA programme and training network globally.
It is acknowledged that the HIV/AIDS epidemic poses a serious threat to global health. HIV disease kills over 1 million people a year, mainly in countries with limited resources. Furthermore, it is a prime aim of the European Community Development Policy to ‘foster sustainable development and eradicate poverty’ in these countries with the aim of integrating them into the world economy. However, a communicable disease such as HIV/AIDS limits this development and thereby restricts global economy integration. The provision of affordable health care for resource-poor countries is now of prime importance if these diseases are to be controlled and eradicated. More importantly, the provision of anti-retroviral therapy or vaccines via clinical networks requires the appropriate laboratory support. The success of the previous FP5 project has placed this team into a global leading position that will facilitate the development of self sustenance. This will, in turn, help support essential drug policies, and enable a rapid and efficient transfer of technical resources from Europe to developing nations.
The project will focus upon the training requirements and implementation of standardised diagnostic and laboratory protocols for CD4+ T lymphocyte analysis. This will include the organisation and implementation of training protocols at local and international level as well as implementing external quality assessment systems for monitoring the training effectiveness in the resource-poor setting. The special advantage of this SSA is that it will provide open access for laboratories in countries with limited resources to laboratories undertaking similar activities in the Western world. This arrangement is the only possible option for the regular use of essential diagnostic/monitoring tests in resource-poor countries.
These tasks, taken together, will fulfil the requirements for a Specific Support Action (SSA) to underpin successful clinical European and global HIV drug and vaccine trials. The protocols developed within the successful FP5 project that introduced stable flow-cytometry control materials for use in, and distribution by, UK NEQAS for Leucocyte Immunophenotyping programme, will be made available to laboratories in countries with limited resources to provide training and education in order to achieve global standardisation for lymphocyte subset analysis, having particular relevance and emphasis for supporting research in HIV.
This newly established collaborative network will function as an interface for European and global research and development. Furthermore, by using External Quality Assurance (EQA), it will enable laboratories to assist and support communication, education and dialogue on all the relevant regulatory aspects of new and existing laboratory techniques.
UK NEQAS for Leucocyte Immunophenotyping, University of Sheffield Academic Department of Haematology
3 Southbourne Road
S10 2QN Sheffield
Tel: +44 114 267 3600
Fax: +44 114 267 3601