期刊
INTERNATIONAL JOURNAL OF LABORATORY HEMATOLOGY
卷 43, 期 2, 页码 169-183出版社
WILEY
DOI: 10.1111/ijlh.13411
关键词
haemostasis; laboratory automation; precision
类别
This document provides guidance on evaluating new methods for clinical testing, covering the planning and execution of commonly performed screening tests and instrument-specific issues. It also offers advice on selecting an appropriate haemostasis analyser and assessing different aspects of a haemostasis test system.
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.
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