Continued harmonization of the international normalized ratio across a large laboratory network: Evidence of sustained low interlaboratory variation and bias after a change in instrumentation

Emmanuel J Favaloro; Sandya Arunachalam; Kent Chapman; Leonardo Pasalic

doi:10.1093/ajcp/aqae090

Continued harmonization of the international normalized ratio across a large laboratory network: Evidence of sustained low interlaboratory variation and bias after a change in instrumentation

Am J Clin Pathol. 2024 Jul 18:aqae090. doi: 10.1093/ajcp/aqae090. Online ahead of print.

Authors

Emmanuel J Favaloro^{1

2

3}, Sandya Arunachalam⁴, Kent Chapman⁵, Leonardo Pasalic^{1

6}

Affiliations

¹ Department of Haematology, Institute of Clinical Pathology and Medical Research (ICPMR), Sydney Centres for Thrombosis and Haemostasis, NSW Health Pathology, Westmead Hospital, Westmead, New South Wales, Australia.
² School of Dentistry and Medical Sciences, Faculty of Science and Health, Charles Sturt University, Wagga Wagga, New South Wales, Australia.
³ School of Medical Sciences, Faculty of Medicine and Health, University of Sydney, Westmead Hospital, Westmead, New South Wales, Australia.
⁴ RCPAQAP Haematology, St Leonards, New South Wales, Australia.
⁵ Department of Haematology, NSW Health Pathology, John Hunter Hospital, Newcastle, New South Wales, Australia.
⁶ Westmead Clinical School, University of Sydney, Westmead, New South Wales, Australia.

PMID: 39024475
DOI: 10.1093/ajcp/aqae090

Abstract

Objectives: Our objective was to maintain low interlaboratory variation and bias in international normalized ratio (INR) results following a network change in instrumentation and reagents, using a process of ongoing standardization and harmonization.

Methods: Network-wide standardization to new common instrument and reagent platforms followed by network-wide application of a simple novel process of verification of international sensitive index and mean normal prothrombin time values for each new lot of prothrombin time (PT) reagent that does not require use of World Health Organization reference thromboplastin or INR calibration/certified plasma.

Results: The network transitioned from mechanical hemostasis detection instruments with associated PT reagent (Diagnostica Stago; NeoPTimal) to optical detection (ACL TOPs) with associated PT reagent (Werfen; RecombiPlasTin 2G). Comparing 3 years of data for each situation, the network (n = 27 laboratories) maintained low INR variability and bias relative to general mechanical and optical groups and other laboratories.

Conclusions: Harmonized support for patient management of vitamin K antagonists such as warfarin was continuously maintained in our geography, with potentially positive implications for other coagulation laboratories and geographies. For the United States in particular, paucity of US Food and Drug Administration-cleared INR certified plasmas potentially compromises INR test accuracy; our novel approach may provide workable alternatives for other laboratories/networks.

Keywords: EQA; INR; external quality assessment; harmonization; international normalized ratio; standardization.

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