title: Standardization and harmonization of the blood count: the role of International Committee for Standardization in Haematology (ICSH).
abstract: Scientific principles of standardization were first applied in haematology in 1963 when the International Committee for Standardization in Haematology was established with a primary objective to improve the measurement of haemoglobin. Subsequently, ICSH has established Expert Panels on a wide range of haematological topics, including especially a Panel on Cytometry. The purpose of haematological standardization is to obtain precision, accuracy, specificity and harmonization of results between different laboratories in all countries and also between different instruments or methods in the same laboratory. To achieve these objectives ICSH sponsors collaborative studies by scientists from academic centres and from industry and uses a consensus procedure for establishing standards on the basis of the scientific data, followed by an educational programme to ensure that the standards are adopted worldwide. ICSH defines material standards and standardized methods. Material standards are classified as primary international standards, certified reference materials, secondary standards and calibrators. These must be distinguished from control preparations which are intended exclusively for quality control. Standardization of methods must also be considered at four levels: definitive, reference, selected and routine. Each has a place in practice but their roles must be clearly defined. ICSH has an established protocol for evaluation of automated blood cell counters. This defines the levels of precision and accuracy of instrument performance. It is also necessary to assess "clinical utility". The main requirement of the practising haematologist is clinical reliability and harmonization of results for comparability. One of the major functions of ICSH is to provide an interface for collaboration between the manufacturers who develop the instruments and the users in order to achieve this goal.
authors.affiliation: Department of Haematology, Royal Postgraduate Medical School, London, United Kingdom.
authors.forename: S M
authors.initials: SM
authors.lastname: Lewis
mesh_terms: D000925:Anticoagulants / Q000494:pharmacology; D001331:Automation; D001772:Blood Cell Count / Q000187:drug effects / Q000295:instrumentation / Q000379:methods; D001773:Blood Cells / Q000648:ultrastructure; D001800:Blood Specimen Collection / Q000379:methods; D002138:Calibration; D006801:Humans; D007390:International Agencies; D009937:Organizational Objectives; D012015:Reference Standards; D013194:Staining and Labeling / Q000592:standards
chemical_list: D000925:Anticoagulants