TY - JOUR
T1 - Defining a metrologically traceable and sustainable calibration hierarchy of international normalized ratio for monitoring of vitamin K antagonist treatment in accordance with International Organization for Standardization (ISO) 17511
T2 - 2020 standard: communication from the International Federation of Clinical Chemistry and Laboratory Medicine–SSC/ISTH working group on prothrombin time/international normalized ratio standardization
AU - van den Besselaar, Antonius M. H. P.
AU - Stavelin, Anne
AU - Kitchen, Steve
AU - Bryant, Michelle
AU - Tripodi, Armando
AU - Scalambrino, Erica
AU - Clerici, Marigrazia
AU - Herbel, Petra
AU - Jünschke, Anja
AU - Meyer dos Santos, Sascha
AU - Meijer, Piet
AU - Niessen, René W. L. M.
AU - Meijers, Joost C. M.
AU - Thelwell, Craig
AU - Cuker, Adam
AU - Kung, Chun
AU - Cao, Zhenghua
AU - Zander, Norbert
AU - Iwasaki, Yosuke
AU - Depasse, François
AU - van Rijn, Claudia
AU - Baktawar, Shanti
AU - Abdoel, Charmane
AU - Cobbaert, Christa M.
N1 - Publisher Copyright: © 2024 The Authors
PY - 2024/4
Y1 - 2024/4
N2 - Calibration of prothrombin time (PT) in terms of international normalized ratio (INR) has been outlined in “Guidelines for thromboplastins and plasmas used to control oral anticoagulant therapy” (World Health Organization, 2013). The international standard ISO 17511:2020 presents requirements for manufacturers of in vitro diagnostic (IVD) medical devices (MDs) for documenting the calibration hierarchy for a measured quantity in human samples using a specified IVD MD. The objective of this article is to define an unequivocal, metrologically traceable calibration hierarchy for the INR measured in plasma as well as in whole blood samples. Calibration of PT and INR for IVD MDs according to World Health Organization guidelines is similar to that in cases where there is a reference measurement procedure that defines the measurand for value assignment as described in ISO 17511:2020. We conclude that, for PT/INR standardization, the optimal calibration hierarchy includes a primary process to prepare an international reference reagent and measurement procedure that defines the measurand by a value assignment protocol conforming to clause 5.3 of ISO 17511:2020. A panel of freshly prepared human plasma samples from healthy adult individuals and patients on vitamin K antagonists is used as a commutable secondary calibrator as described in ISO 17511:2020. A sustainable metrologically traceable calibration hierarchy for INR should be based on an international protocol for value assignment with a single primary reference thromboplastin and the harmonized manual tilt tube technique for clotting time determination. The primary international reference thromboplastin reagent should be used only for calibration of successive batches of the secondary reference thromboplastin reagent.
AB - Calibration of prothrombin time (PT) in terms of international normalized ratio (INR) has been outlined in “Guidelines for thromboplastins and plasmas used to control oral anticoagulant therapy” (World Health Organization, 2013). The international standard ISO 17511:2020 presents requirements for manufacturers of in vitro diagnostic (IVD) medical devices (MDs) for documenting the calibration hierarchy for a measured quantity in human samples using a specified IVD MD. The objective of this article is to define an unequivocal, metrologically traceable calibration hierarchy for the INR measured in plasma as well as in whole blood samples. Calibration of PT and INR for IVD MDs according to World Health Organization guidelines is similar to that in cases where there is a reference measurement procedure that defines the measurand for value assignment as described in ISO 17511:2020. We conclude that, for PT/INR standardization, the optimal calibration hierarchy includes a primary process to prepare an international reference reagent and measurement procedure that defines the measurand by a value assignment protocol conforming to clause 5.3 of ISO 17511:2020. A panel of freshly prepared human plasma samples from healthy adult individuals and patients on vitamin K antagonists is used as a commutable secondary calibrator as described in ISO 17511:2020. A sustainable metrologically traceable calibration hierarchy for INR should be based on an international protocol for value assignment with a single primary reference thromboplastin and the harmonized manual tilt tube technique for clotting time determination. The primary international reference thromboplastin reagent should be used only for calibration of successive batches of the secondary reference thromboplastin reagent.
KW - anticoagulants
KW - calibration
KW - international normalized ratio
KW - metrological traceability
KW - prothrombin time
KW - thromboplastin
UR - http://www.scopus.com/inward/record.url?scp=85183014497&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.jtha.2023.12.013
DO - https://doi.org/10.1016/j.jtha.2023.12.013
M3 - Article
C2 - 38128762
SN - 1538-7933
VL - 22
SP - 1236
EP - 1248
JO - Journal of thrombosis and haemostasis
JF - Journal of thrombosis and haemostasis
IS - 4
ER -