International Council for Standardization in Haematology (ICSH) laboratory guidance for the verification of haemostasis analyser‐reagent test systems. Part 2: Specialist tests and calibrated assays
Chris Gardiner, Robyn Coleman, Moniek P.M. de Maat, Akbar Dorgalaleh, Marión Echenagucia, Robert C. Gosselin, Masahiro Ieko, Steve Kitchen
Abstract
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.
Topics & Concepts
StandardizationAnalyserMedical physicsMedicineTest (biology)HematologyInternal medicineChemistryChromatographyComputer scienceBiologyPaleontologyOperating systemHemophilia Treatment and ResearchBlood Coagulation and Thrombosis MechanismsBlood transfusion and management