International trend of hematopoietic tumor antigen analysis by flow Cytometry

Abstract

Immunophenotypic analysis of hematopoietic tumors by fl ow cytometry (FCM) is an important technique in diagnosing hematologic malignancies and evaluating therapeutic effectiveness. By improving the accuracy and stability of flow cytometer and analysis software over the years, it has become possible to acquire highly reliable data at voluntary facilities. However, FCM is not mature; it is not a complete technology. The development of devices and fl uorescent dyes that enable multicolor analysis is still ongoing. Therefore, clinical fl ow cytometry is a typical Laboratory developed test (LDT). From this, it is necessary to defi ne appropriate strategies in order to obtain equivalent results among labs, and standard guidelines with appropriate validation are required. In 2013 the International Council for Standardization in Haematology (ICSH) and the International Clinical Cytometry Society (ICCS) reported comprehensive guidelines for LDTs using FCM, including from analysis to post-analysis report, at the request of the FDA. In standardization of hematopoietic tumor analysis using FCM, one of the most dynamic approaches is the guideline proposed by EuroFlow, a division of European Scientifi c Foundation for Laboratory Hemato Oncology (ESLHO). A number of proposals have been reported, including the 2006 Bethesda International Consensus Panel, the recommended panel based on WP 10 of European Leukemia Net (ELN), and the Harmonemia project to obtain the same data with various fl ow cytometers. In this paper, we introduce this information and consider the direction of standardization of FCM.