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ICSH issues guidance on verifying and implementing specialist haemostatic tests for regulatory compliance.
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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, verification and implementation processes required by regulatory and accreditation bodies. It covers the planning and verification of specialist haemostatic tests, including factor assays, D-dimers, direct anticoagulants and thrombophilia testing.
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Gardiner et al. (2021) reported a review. Verification of haemostasis analyser-reagent test systems was evaluated. The ICSH document provides laboratory guidance for the performance, verification, and implementation processes of specialist haemostatic tests as required by regulatory and accreditation bodies.
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