Premium
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
Author(s) -
Gardiner Chris,
Coleman Robyn,
Maat Moniek P. M.,
Dorgalaleh Akbar,
Echenagucia Marión,
Gosselin Robert C.,
Ieko Masahiro,
Kitchen Steve
Publication year - 2021
Publication title -
international journal of laboratory hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.705
H-Index - 55
eISSN - 1751-553X
pISSN - 1751-5521
DOI - 10.1111/ijlh.13550
Subject(s) - standardization , medical physics , analyser , test (biology) , medicine , accreditation , good laboratory practice , thrombophilia , traceability , computer science , pathology , software engineering , medical education , chemistry , thrombosis , quality assurance , biology , chromatography , paleontology , operating system , external quality assessment
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.