Performance of the LumiraDx Platform INR test in an anticoagulation clinic point-of-care setting compared with an established laboratory reference method

Tait, R. C. , Hung, A. and Gardner, R. S. (2019) Performance of the LumiraDx Platform INR test in an anticoagulation clinic point-of-care setting compared with an established laboratory reference method. Clinical and Applied Thrombosis/Hemostasis, 25, p. 1076029619890423. (doi: 10.1177/1076029619890423) (PMID:31773973) (PMCID:PMC7019395)

Abstract

Vitamin K antagonists, such as warfarin, have a narrow therapeutic window; patients on these therapies therefore require regular international normalized ratio (INR) monitoring to maintain optimal dosing. This involves periodic checks and laboratory testing using venepuncture, which are often perceived as a burden. This study aimed to determine the accuracy and precision of the LumiraDx INR Test, a new point-of-care in vitro diagnostic platform, in an anticoagulation clinic setting. In this observational, cross-sectional study, precision of the LumiraDx INR Test was assessed using paired replicate samples (n = 366) and 3 test strip lots. Accuracy was determined by comparing capillary blood INR, ascertained by the LumiraDx INR Test, with venous plasma INR, measured by the laboratory reference instrument, the IL ACL ELITE Pro. Furthermore, INR was assessed across a range of hematocrit (25%-55%). In addition, feedback was collected from health-care professionals via a self-completed questionnaire. This trial was registered at ClinicalTrials.gov (NCT03682419). The precision (% coefficient of variation) of the LumiraDx INR Test was <4 when samples were applied by direct application or via a capillary transfer pipette, as well as between test strip lots. Accuracy of the LumiraDx INR Test, across the INR range of 0.8 to 7.5, was confirmed by a strong correlation of 0.965 (95% confidence interval: 0.959-0.970) when compared with the IL ACL ELITE Pro, which was maintained across the hematocrit range. Feedback from health-care professionals indicated that the instructions given by the system were easy to follow. In conclusion, the strong agreement between the LumiraDx Platform INR point-of-care test and the IL ACL ELITE Pro laboratory reference system, as well as between the different application methods and test lots, indicates that it can provide a rapid, accurate, and reliable INR analysis.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Gardner, Professor Roy and Tait, Dr Robert
• Authors: Tait, R. C., Hung, A., and Gardner, R. S.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
• Journal Name: Clinical and Applied Thrombosis/Hemostasis
• Publisher: SAGE Publications
• ISSN: 1076-0296
• ISSN (Online): 1938-2723
• Published Online: 27 November 2019
• Copyright Holders: Copyright © 2019 The Authors
• First Published: First published in Clinical and Applied Thrombosis/Hemostasis 25: 1076029619890423
• Publisher Policy: Reproduced under a Creative Commons License