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Performance Evaluation of the Quantitative Point-of-Care LumiraDx d-Dimer Test

INTRODUCTION: Fibrin degradation product d-dimer can be a valuable indicator for venous thromboembolism (VTE). The use of d-dimer testing in primary care settings can be limited by restricted access to laboratory services. This performance evaluation compares a quantitative, point-of-care (POC) d-di...

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Autores principales: Ellis, Jayne E., Johnston, Thomas W., Craig, David, Scribner, Anita, Simon, William, Kirstein, Judith
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8496146/
https://www.ncbi.nlm.nih.gov/pubmed/34618321
http://dx.doi.org/10.1007/s40119-021-00241-7
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author Ellis, Jayne E.
Johnston, Thomas W.
Craig, David
Scribner, Anita
Simon, William
Kirstein, Judith
author_facet Ellis, Jayne E.
Johnston, Thomas W.
Craig, David
Scribner, Anita
Simon, William
Kirstein, Judith
author_sort Ellis, Jayne E.
collection PubMed
description INTRODUCTION: Fibrin degradation product d-dimer can be a valuable indicator for venous thromboembolism (VTE). The use of d-dimer testing in primary care settings can be limited by restricted access to laboratory services. This performance evaluation compares a quantitative, point-of-care (POC) d-dimer assay (LumiraDx d-Dimer Test) with a reference laboratory-based d-dimer assay. METHODS: Plasma samples from patients presenting to secondary care in the UK, USA, and Germany were analyzed centrally using the LumiraDx d-Dimer Test and the reference test (bioMérieux VIDAS d-Dimer Exclusion II immunoassay). Method comparison used Passing–Bablok regression analysis with pre-specified equivalence criteria of r ≥ 0.9 and slope of 0.9–1.1. The NOVEL-3 study (NCT04375982) compared equivalency of fingerstick, venous blood (VB), and plasma samples from the same patient, tested at US primary care clinics next to the patient using the POC LumiraDx d-Dimer device. Measurements obtained from fingerstick and VB samples were compared with results from plasma samples, using Deming regression. The healthy reference range was determined using plasma samples of healthy volunteers, collected by commercial suppliers in Germany and the USA, which were analyzed centrally using the LumiraDx d-Dimer Test and the reference test. RESULTS: The LumiraDx d-Dimer Test demonstrated agreement with the bioMérieux VIDAS d-Dimer Exclusion II immunoassay for plasma samples (r = 0.923, slope of 1.016, n = 1767). There was good agreement between fingerstick/VB samples and plasma samples (r = 0.980–0.986, n = 93) measured using the LumiraDx d-Dimer Test. Overall error rates were 1.8%. The healthy reference range 90% percentile for d-dimer was calculated as 533 µg/l fibrinogen equivalent units (FEU). CONCLUSIONS: The quantitative LumiraDx d-Dimer Test is easy to use and can accurately measure d-dimer levels in a range of blood sample types, including fingerstick samples, which could improve assessment of VTE cases in community and hospital near-patient settings.
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spelling pubmed-84961462021-10-08 Performance Evaluation of the Quantitative Point-of-Care LumiraDx d-Dimer Test Ellis, Jayne E. Johnston, Thomas W. Craig, David Scribner, Anita Simon, William Kirstein, Judith Cardiol Ther Original Research INTRODUCTION: Fibrin degradation product d-dimer can be a valuable indicator for venous thromboembolism (VTE). The use of d-dimer testing in primary care settings can be limited by restricted access to laboratory services. This performance evaluation compares a quantitative, point-of-care (POC) d-dimer assay (LumiraDx d-Dimer Test) with a reference laboratory-based d-dimer assay. METHODS: Plasma samples from patients presenting to secondary care in the UK, USA, and Germany were analyzed centrally using the LumiraDx d-Dimer Test and the reference test (bioMérieux VIDAS d-Dimer Exclusion II immunoassay). Method comparison used Passing–Bablok regression analysis with pre-specified equivalence criteria of r ≥ 0.9 and slope of 0.9–1.1. The NOVEL-3 study (NCT04375982) compared equivalency of fingerstick, venous blood (VB), and plasma samples from the same patient, tested at US primary care clinics next to the patient using the POC LumiraDx d-Dimer device. Measurements obtained from fingerstick and VB samples were compared with results from plasma samples, using Deming regression. The healthy reference range was determined using plasma samples of healthy volunteers, collected by commercial suppliers in Germany and the USA, which were analyzed centrally using the LumiraDx d-Dimer Test and the reference test. RESULTS: The LumiraDx d-Dimer Test demonstrated agreement with the bioMérieux VIDAS d-Dimer Exclusion II immunoassay for plasma samples (r = 0.923, slope of 1.016, n = 1767). There was good agreement between fingerstick/VB samples and plasma samples (r = 0.980–0.986, n = 93) measured using the LumiraDx d-Dimer Test. Overall error rates were 1.8%. The healthy reference range 90% percentile for d-dimer was calculated as 533 µg/l fibrinogen equivalent units (FEU). CONCLUSIONS: The quantitative LumiraDx d-Dimer Test is easy to use and can accurately measure d-dimer levels in a range of blood sample types, including fingerstick samples, which could improve assessment of VTE cases in community and hospital near-patient settings. Springer Healthcare 2021-10-07 2021-12 /pmc/articles/PMC8496146/ /pubmed/34618321 http://dx.doi.org/10.1007/s40119-021-00241-7 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Ellis, Jayne E.
Johnston, Thomas W.
Craig, David
Scribner, Anita
Simon, William
Kirstein, Judith
Performance Evaluation of the Quantitative Point-of-Care LumiraDx d-Dimer Test
title Performance Evaluation of the Quantitative Point-of-Care LumiraDx d-Dimer Test
title_full Performance Evaluation of the Quantitative Point-of-Care LumiraDx d-Dimer Test
title_fullStr Performance Evaluation of the Quantitative Point-of-Care LumiraDx d-Dimer Test
title_full_unstemmed Performance Evaluation of the Quantitative Point-of-Care LumiraDx d-Dimer Test
title_short Performance Evaluation of the Quantitative Point-of-Care LumiraDx d-Dimer Test
title_sort performance evaluation of the quantitative point-of-care lumiradx d-dimer test
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8496146/
https://www.ncbi.nlm.nih.gov/pubmed/34618321
http://dx.doi.org/10.1007/s40119-021-00241-7
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