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The algorithm in Figure 7 summarizes the overall approach to fitting a single reference distribution. If no statistically significant difference is found, the investigation should assess whether the power of the chi-squared test was insufficient to detect differences of practical significance. If a statistical difference is found, Appendices B and C and Figure 6 may be used to determine whether the sample size and the power have led to the detection of an effect size too small to be of importance.
The Expert Panel on Blood Rheology of the International Council for Standardization in Haematology (ICSH) has prepared new recommendations for measurement of the erythrocyte sedimentation rate (ESR) under the following categories: 1. ICSH reference method-ICSH now recognises, as its reference method for the ESR, the sedimentation of EDTA-anticoagulated but undiluted blood in traditional Westergren pipettes that meet ICSH specifications. 2. ICSH standardised method-ICSH recommends specifications for a new standardised method for the ESR based on the sedimentation of EDTA-anticoagulated, but undiluted blood in pipettes with a 200 mm scale and which are designed to avoid spillage of blood or aerosol generation. This standardised method may be used for verification or quality control of other ESR methods and, in future, may replace the reference method. 3. ICSH selected methods-ICSH recommends specifications for working methods, using diluted or undiluted blood, which may be considered as ICSH selected methods for routine use. A protocol is outlined for evaluation of such working methods against the ICSH reference method or the new ICSH standardised method.
The classification of acute leukaemias is now widely based on a combined morphological, cytochemical and immunophenotyping approach. Difficulties are frequently encountered however in reaching an acceptable degree of diagnostic concordance between different laboratories because of variations in the techniques used (in terms of methodologies, reagents and equipment) and diagnostic interpretation. The International Council for Standardization in Haematology (ICSH) convened an expert panel to consider currently available diagnostic techniques with the aim of defining a minimum cytochemical and immunological diagnostic panel that could be used as core components for the classification of acute leukemia. The proposed ICSH scheme, which attempts to balance the basic requirement for providing precise and informative diagnostic information without limiting its use to only those laboratories with sophisticated facilities, is based on three sequential levels of investigation; primary cytochemistry, intracellular phenotyping and membrane immunophenotyping. The minimum ICSH recommended cytochemistries comprise myeloperoxidase (MPO), chloroacetate esterase (ChlorE) and alpha-naphthyl acetate esterase (ANAE), and standardised methods for these cytochemistries are detailed in this communication. For cases of acute leukaemia that remain unclassified by primary cytochemistry, subsequent immunological analyses for cytoplasmic CD3, CD22, MPO and nuclear TdT are recommended. The ICSH panel considers that the use of these minimum primary cytochemical and intracellular phenotyping procedures will lead to the consistent classification of most acute leukaemias, and that the third level of investigation (membrane immunophenotyping) should be used for the purposes of confirmation, diagnostic clarification of atypical leukaemias, and the subtyping of acute lymphoblastic leukaemias (ALL). The ICSH panel also recognised that there are a number of additional technologies which can provide definitive diagnostic information, such as cytogenetics and DNA genotyping, but these were excluded from the minimum panel because of their restricted availability. While many specialised laboratories, particularly in the areas of diagnostic research, will continue to use individual investigatory protocols, it is considered that the inclusion of the ICSH scheme as core components would lead to greater consistency when comparing independent studies of acute leukemia.
The spun packed cell volume (PCV, hematocrit) is a key measurement on which are based hematology instrument calibration, reference range determination, and assignment of values to calibrators/controls. In 2001, the International Council for Standardization in Haematology (ICSH) recommended a Reference PCV method, which is fully traceable to the ICSH reference hemoglobin method. Because of its complexity, however, this method is impractical for occasional use in routine laboratories and is therefore intended primarily for use by manufacturers of capillary microhematocrit tubes, liquid calibrators, and multichannel analyzers. In response to the need for a simpler method--accessible to all routine laboratories--the ICSH offers this "Surrogate Reference" PCV procedure. It is traceable to the original ICSH Reference PCV method and is based on spun PCVs obtained using borosilicate capillary tubes with an already-known relationship to this reference procedure. This ICSH "Surrogate Reference" PCV method is substantially simpler, thus putting it within the reach of most routine hematology laboratories.
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.
Standardization and harmonization in Laboratory testing are a key issue in the midst of globalization era, because most of laboratory testing has been currently achieved with various kinds of automated systems. In the developed countries, automated systems with highly-regulated principles are commonly used in the routine laboratory. However, there are so many undeveloped and developing countries in Asia that diversity of testing levels can be observed in the area. Some laboratories use glass chamber method for blood cell counting, while other laboratory use semi-automated or fully automated analyzers for complete blood count. International standardization on Hematology is focused on the developed system but not for the developing system. Established standardized documents therefore whould not be unsuitable for Asian societies. In the context, International Council for Standardization in Hematology (ICSH) changed its rules to adjust our Asian Societies and ICSH started to restructure the body. International ICSH society is divided into 5 region sub-groups. Asian area is able to possess one new sub-society, ICSH-Asia. Its reconstruction work has been just started with Asain colleagues, and we are now extending the new societies to discuss Asian problems on the quality of hematology testing.
The International Council for Standardization in Haematology (ICSH), an international organization promoting international agreement on hematological testing, is now restructuring to strengthen its activities. In Asia, a diversity of testing methods exists and the resulting testing levels make it difficult to compare test results internationally among Asian countries. Fortunately, the ICSH is considering regionalizing its organization to 5 sub-societies to increase its activity, and we have been able to establish a new society, ICSH-Asia, under the ICSH umbrella.
This document has been prepared by an ICSH Task Force as a proposed ICSH Standard for Blood Specimen Collection for Reference Values. The procedures described are a model for standardization of blood specimen collection either for people confined to bed, or for those who are ambulant; they are intended for obtaining reference values using the principles described in the ICSH paper on the Theory of Reference Values (Clin. lab. Haemat. 3, 369-373, 1981). The document is based on recommendations by the Committee on Reference Values of the Scandinavian Society for Clinical Chemistry and Clinical Physiology as published in Scand. J. clin. lab. Invest. (35, Suppl. 144, 39-43, 1975); it has been prepared in collaboration with the Panel on the Theory of Reference Values of the Scientific Committee of the International Federation of Clinical Chemistry (IFCC). The responsible authorities of ICSH and IFCC have proposed that it should be the basis for joint recommendations by both organizations.
This protocol is proposed for the evaluation of automated blood cell counters to assess the performance, advantages and limitations of such instruments. It is based on the International Committee for Standardization in Haematology (ICSH) 'Protocol for type testing equipment and apparatus used for haematological analysis' (1978a) and the British Committee for Standardization in Haematology 'Guidelines for the evaluation of instruments used in haematology' (Shinton, England & Kennedy, 1982). The document has been prepared by the ICSH Panel on Cytometry after discussion with colleagues. This tentative protocol will be reviewed 1 year after publication, in accordance with the ICSH rules, before it is adopted as a definitive standard.
Scientific symposia on haemoglobinometry were held at the 9th Congress of the European Society of Haematology, Lisbon, 1963 (ESH 1964) and the 10th Congress of the International Society of Haematology (ISH), Stockholm, 1964 (ISH 1965). The International Committee for Standardization in Haematology (ICSH) made recommendations endorsed by the General Assembly of ICSH in Sydney on 23 August 1966 (ICSH 1967), for a reference method for haemoglobinometry and for the manufacture and distribution of an international reference preparation. Further symposia were held at the 12th Congress of the ISH, New York, 1968 (Astaldi, Sirtori & Vanzetti 1979) and at the 13th Congress of ISH, Munich, 1970 (Izak & Lewis 1972). The recommendations were reissued in 1978 (ISH 1978). On the basis of continuing experimental studies, the reference method and the specifications for the international reference preparation have been modified. The revised recommendations are described in this document.
The decomposition on freezing of reagents used for the determination of total haemoglobin in blood was reinvestigated. When these reagents containing hexacyanoferrate(III) (ferricyanide) and cyanide are frozen and then thawed, hexacyanoferrate(III) is reduced to hexacyanoferrate(II) (ferrocyanide), cyanide being oxidized to (CN)2. At higher concentrations of the reactants than those present in the ICSH-recommended reagents, this reaction proceeds also at room temperature. During the process of freezing the reaction proceeds at low overall concentration of the reactants because the reactants become highly concentrated at the moving phase boundary. There is no evidence that the reaction that takes place on freezing can be prevented by the addition of ethanol, methanol, ethylene glycol or glycerol. Addition of these compounds does not affect the suitability of the reagent for use in haemoglobinometry.
A viable alternative to the ICSH reference method for serum iron assay is proposed where automated batch analysis is required. The introduction of Ferrozene into contemporary automated methodology makes this possible. The Donnan effect on membrane dialysis has been resolved by observing the fate of aqueous and protein matrices inoculated with 59FeCl3 as they leave the system.
This paper describes the preparation and nature of the First International Standard for Human Urinary Follicle Stimulating Hormone and for Human Urinary Luteinizing Hormone, for Bioassay, and of two batches of working standard which were prepared from the same material. A collaborative study of these materials was carried out by six laboratories in six different countries. The FSH and LH activities of the Standard were assayed in terms of those of the Second International Reference Preparation of Human Menopausal Gonadotrophins, Urinary, for Bioassay, which it replaces. The results from 20 valid FSH assays and 30 valid LH assays (using four different methods) obtained in this way gave a weighted combined potency estimate for FSH of 53.7 IU, with 95 % fiducial limits of 47.2-61.1 IU, and for LH of 46.2 IU, with 95 % fiducial limits of 43.3-49.3 IU. Accelerated degradation studies of the Standard stored at elevated temperatures suggested that the stability of both FSH and LH activities under normal storage conditions would be satisfactory. The FSH and LH activities of the two batches of working standard (WS-A and WS-B) were compared with those of the Standard and were not found to differ significantly, except for the LH activity of WS-B which appeared to be slightly higher than that of the Standard. Accelerated degradation studies did not show any significant differences in stability between the Standard and batches of working standards. On the basis of these results the Standard has been established by WHO and allocated a potency for FSH of 54 IU per ampoule and for LH 46 IU per ampoule. The International Units for FSH, Human Urinary, for Bioassay and for LH (ICSH), Human Urinary, for Bioassay are thus defined as the activities contained in 0.1138 mg and 0.13369 mg of the International Standard, respectively.
The partial thromboplastin time (PTT) test is widely used as a screening test for the detection of hemophilia. It is also used to monitor patients on heparin anticoagulation. This proposal from a ICSH Panel proposes guidelines for the performance of this test, including comparable reference ranges, precision and sensitivity requirements.
An international collaborative exercise has been undertaken to calibrate a secondary international reference preparation (IRP) of thromboplastin on behalf of the International Committee for Standardization in Haematology (ICSH). This preparation of British Comparative Thromboplastin (BCT/441) is required because supplies of the WHO primary IRP (BCT/253) are necessarily limited. The calibration was performed at seven centres with only a small degree of interlaboratory variation. As a result of this study an ISI value of 1.04 has been assigned to the preparation. Opportunity was also taken to assess the reliability of a simplified calibration based on lyophilised plasmas. The results of the latter appeared reliable. BCT/441 will be available to officially designated National Control Laboratories for calibration of local thromboplastins to promote prothrombin time standardization in oral anticoagulant control.
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