International Council for Standardization in Haematology (ICSH) laboratory guidance for the evaluation of haemostasis analyser-reagent test systems. Part 1: Instrument-specific issues and commonly used coagulation screening tests.
| Autor: | Gardiner C; Haemostasis Research Unit, University College London, London, UK., Coleman R; Department of Haematology, Sullivan Nicolaides Pathology, Bowen Hills, QLD, Australia., de Maat MPM; Department of Haematology, Erasmus Medical Centre, Rotterdam, The Netherlands., Dorgalaleh A; Department of Hematology and Blood Transfusion, School of Allied Medicine, Iran University of Medical Sciences, Tehran, Iran., Echenagucia M; Centro Nacional de Hemofilia, Banco Municipal de Sangre del Distrito Capital, Caracas, Venezuela., Gosselin RC; Thrombosis and Hemostasis Center, University of California, Davis Health System, Sacramento, CA, USA., Ieko M; Health Sciences University of Hokkaido, Ishikari-Tobetsu, Japan., Kitchen S; Sheffield Haemophilia and Thrombosis Centre, Royal Hallamshire Hospital, Sheffield, UK. |
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| Jazyk: | angličtina |
| Zdroj: | International journal of laboratory hematology [Int J Lab Hematol] 2021 Apr; Vol. 43 (2), pp. 169-183. Date of Electronic Publication: 2020 Nov 29. |
| DOI: | 10.1111/ijlh.13411 |
| Abstrakt: | Before a new method is used for clinical testing, it is essential that it is evaluated for suitability for its intended purpose. This document gives guidance for the performance of verification, validation and implementation processes required by regulatory and accreditation bodies. It covers the planning and execution of an evaluation of the commonly performed screening tests (prothrombin time, activated partial thromboplastin time, thrombin time and fibrinogen assay), and instrument-specific issues. Advice on selecting an appropriate haemostasis analyser, planning the evaluation, and assessing the reference, interval, precision, accuracy, and comparability of a haemostasis test system are also given. A second companion document will cover specialist haemostasis testing. (© 2020 John Wiley & Sons Ltd.) |
| Databáze: | MEDLINE |
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