Flow cytometric cell analysis has evolved as an important diagnostic tool in the clinical laboratory. Diagnostic applications include:
1) the enumeration ofIymphocyte subsets and assessment of their activation status and function in immunodeficiency (AIDS, transplantation) and autoimmunity;
2) immunological characterization of hematological malignancies for classification and monitoring of residual disease;
3) platelet activation as a prognostic marker in cardiovascular disease and analysis of platelet function in coagulation disorders; and
4) enumeration of hematopoietic progenitor cells for timing, dosing and quality control of stem cell transplants for cancer treatment. The increasing sophistication of flow cytometric techniques has greatly advanced the sensitivity and specificity of the above assays. At the same time, their application by an ever-widening range of laboratories calls for technology standardization, establishment of common assay protocols and the implementationof external quality assessment schemes.
The European Working Group on Clinical Cell Analysis brings together, through this Reinforced Concertation programme, 16 groups in 13 European countries engaged in flow cytometric diagnostic applications and the industrial partners supplying the technology for these fields. The united expertise of these groupscovers the main technological areas needed for most flow cytometric diagnostic applications. The first goal of the programme is to optimize the required technologies and to reach consensus on their use: a) instrument set-up and calibration; b) sample preparation for multicolor flow cytometry; c) absolute cell count assessment; d) intracellular staining; e) quantitation of antigen expression; and f) flow cytometric data analysis. This first set of deliverables is to be completed during the first 15 months of the programme through 3 consensus meetings and experimentation at the partner laboratories of the project. During the subsequent 3 months, consensus protocols are established for the above outlined four diagnostic areas of clinical application of flow cytometry.
At the same time, study protocols to confirm theclinical utility of these assays are designed. The final 18 months of the programme are dedicated to the multi-centre execution of the clinical study protocols. The programme is concluded by a final consensus meeting, during which the clinical set of delilterables is established: verified clinical diagnostic indications and 'real-time tested' standard protocols for flow cytometric assays in the 4 diagnostic areas outlined above. Exploitation: At the level of the individual countries, each partner will disseminate the project deliverables (i.e., the standardized assays based on optimized flow cytometric technology) to all clinical diagnostic laboratories in those countries through the national societies or organizations involved in quality control of clinical diagnostic assays. External quality assessment schedules are set up at national levels and will be coordinated through the European Working Group for Clinical Cell Analysis. Interaction with industrial partners on optimization of flow cytometric technology and assay standardization will enable them to provide the European market with the desired products tailored to the existing needs.