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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) 17511:2020 standard: communication from the International Federation of Clinical Chemistry and Laboratory Medicine-SSC/ISTH working group on prothrombin time/international normalized ratio standardization.
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- Additional Information
- Source:
Publisher: Elsevier Country of Publication: England NLM ID: 101170508 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1538-7836 (Electronic) Linking ISSN: 15387836 NLM ISO Abbreviation: J Thromb Haemost Subsets: MEDLINE
- Publication Information:
Publication: 2023- : [New York] : Elsevier
Original Publication: Oxford : Blackwell Pub.
- Subject Terms:
- Abstract:
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.
Competing Interests: Declaration of competing interests A.C. has served as a consultant for Synergy, New York Blood Center, and MingSight Pharmaceuticals and has received authorship royalties from UpToDate. S.K. has received consultancy payments from Werfen. N.Z. is an employee of Siemens Healthineers. P.H., A.J., and S.M.d.D. are employees of Roche Diagnostics GmbH. C.K. and Z.C. are employed by Werfen, Orangeburg, NY. Y.I. is employed by Sysmex Corporation. F.D. is employed by Diagnostica Stago. All other authors declare no relevant conflicts of interest.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
- Contributed Indexing:
Keywords: anticoagulants; calibration; international normalized ratio; metrological traceability; prothrombin time; thromboplastin
- Accession Number:
9035-58-9 (Thromboplastin)
0 (Anticoagulants)
0 (Fibrinolytic Agents)
0 (Indicators and Reagents)
12001-79-5 (Vitamin K)
- Publication Date:
Date Created: 20231221 Date Completed: 20240325 Latest Revision: 20240325
- Publication Date:
20240325
- Accession Number:
10.1016/j.jtha.2023.12.013
- Accession Number:
38128762
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