Monoclonal antibody panels for acute leukemia and myelodysplastic syndromediagnosis - Results of a co-operative quality control group

The need for standardization criteria and result reproducibility in immunop henotyping hematological diseases has increased along with their clinical i mportance. Our group "Policentric Study Group on Immunological Markers", is composed of 40 laboratories. Its aim, over recent years, has been to find a standardized way of immunophenotypic analysis applicable to various hemat ological diseases. The objective of this study is to contribute to the deba te concerning standardization of monoclonal antibody panels and immunopheno typic analysis procedures in acute leukemia (AL) and myelodysplastic syndro me (MDS), with the following targets: to improve interlaboratory reproducibility of the immunophenotyping data, a nd interpretative results; to study, with improved feasibility, correlation between immunophenotype an d clinical or biological findings on a large number of AL and MDS cases; to verity the utility of the proposed monoclonal antibody panels for proper AL and MDS classification, and to detect minimal residual disease. In the field of AL and MDS our experience is based on about 1800 and 700 ca ses respectively analyzed over the last five years. Starting from these exp eriences and data of the literature we have elaborated the proposed panels of monoclonal antibodies and the methods of analysis. We have suggested a s tandardized immunophenotypic approach to study AL and MDS. In particular ou r work has focused on the gating strategy. This aims at drawing a gate of a nalysis having high purity and recovery, and on the choice of monoclonal an tibody combinations for multiparametric analysis, particularly the normal a ntigen expression on each step of lineage differentiation or their clinical ly relevant aberrant expressions. A standardized criteria has become a nece ssary starting point in any kind of analytical process. In the field of acu te leukemias and myelodysplastic syndromes the work of this polycentric gro up has focused on the pre-analytical and analytical steps to be taken in cy tometric evaluation of hematological malignancies. The results obtained may contribute to reaching intra and inter-laboratory reproducibility.