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Performance of the LumiraDx Platform INR Test in an Anticoagulation Clinic Point-of-Care Setting Compared With an Established Laboratory Reference Method

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 percei...

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Autores principales: Tait, Robert Campbell, Hung, Annielle, Gardner, Roy S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7019395/
https://www.ncbi.nlm.nih.gov/pubmed/31773973
http://dx.doi.org/10.1177/1076029619890423
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author Tait, Robert Campbell
Hung, Annielle
Gardner, Roy S.
author_facet Tait, Robert Campbell
Hung, Annielle
Gardner, Roy S.
author_sort Tait, Robert Campbell
collection PubMed
description 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.
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spelling pubmed-70193952020-02-27 Performance of the LumiraDx Platform INR Test in an Anticoagulation Clinic Point-of-Care Setting Compared With an Established Laboratory Reference Method Tait, Robert Campbell Hung, Annielle Gardner, Roy S. Clin Appl Thromb Hemost Original Article 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. SAGE Publications 2019-11-27 /pmc/articles/PMC7019395/ /pubmed/31773973 http://dx.doi.org/10.1177/1076029619890423 Text en © The Author(s) 2019 http://creativecommons.org/licenses/by-nc/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Article
Tait, Robert Campbell
Hung, Annielle
Gardner, Roy S.
Performance of the LumiraDx Platform INR Test in an Anticoagulation Clinic Point-of-Care Setting Compared With an Established Laboratory Reference Method
title Performance of the LumiraDx Platform INR Test in an Anticoagulation Clinic Point-of-Care Setting Compared With an Established Laboratory Reference Method
title_full Performance of the LumiraDx Platform INR Test in an Anticoagulation Clinic Point-of-Care Setting Compared With an Established Laboratory Reference Method
title_fullStr Performance of the LumiraDx Platform INR Test in an Anticoagulation Clinic Point-of-Care Setting Compared With an Established Laboratory Reference Method
title_full_unstemmed Performance of the LumiraDx Platform INR Test in an Anticoagulation Clinic Point-of-Care Setting Compared With an Established Laboratory Reference Method
title_short Performance of the LumiraDx Platform INR Test in an Anticoagulation Clinic Point-of-Care Setting Compared With an Established Laboratory Reference Method
title_sort performance of the lumiradx platform inr test in an anticoagulation clinic point-of-care setting compared with an established laboratory reference method
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7019395/
https://www.ncbi.nlm.nih.gov/pubmed/31773973
http://dx.doi.org/10.1177/1076029619890423
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