TY - JOUR
T1 - International Council for Standardization in Haematology (ICSH) laboratory guidance for the evaluation of haemostasis analyser-reagent test systems. Part 1
T2 - Instrument-specific issues and commonly used coagulation screening tests
AU - Gardiner, Chris
AU - Coleman, Robyn
AU - de Maat, Moniek P.M.
AU - Dorgalaleh, Akbar
AU - Echenagucia, Marión
AU - Gosselin, Robert C.
AU - Ieko, Masahiro
AU - Kitchen, Steve
N1 - Publisher Copyright:
© 2020 John Wiley & Sons Ltd
PY - 2021/4
Y1 - 2021/4
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/85096849861
U2 - 10.1111/ijlh.13411
DO - 10.1111/ijlh.13411
M3 - Review article
C2 - 33249720
AN - SCOPUS:85096849861
SN - 1751-5521
VL - 43
SP - 169
EP - 183
JO - International Journal of Laboratory Hematology
JF - International Journal of Laboratory Hematology
IS - 2
ER -