Evaluation of a Point-of-Care N-Terminal Pro-Brain Natriuretic Peptide Assay for Heart Failure Management.

IF 1.3 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS

Cardiology Research Pub Date : 2025-10-10 eCollection Date: 2025-10-01 DOI:10.14740/cr2117

Florian Belik, Meryem Benamour, Antoine Laffalize, Thibault Lavalleye, Louisa Van Belle, Anne-Catherine Pouleur, Damien Gruson

{"title":"Evaluation of a Point-of-Care N-Terminal Pro-Brain Natriuretic Peptide Assay for Heart Failure Management.","authors":"Florian Belik, Meryem Benamour, Antoine Laffalize, Thibault Lavalleye, Louisa Van Belle, Anne-Catherine Pouleur, Damien Gruson","doi":"10.14740/cr2117","DOIUrl":null,"url":null,"abstract":"Background: N-terminal pro-brain natriuretic peptide (NT-proBNP) is a key biomarker in heart failure (HF) diagnosis and management. This study aimed to evaluate performances of the LumiraDx® NT-proBNP, a point-of-care testing (POCT) device, focusing on imprecision, method comparison, and clinical practicability.Methods: The LumiraDx® NT-proBNP test was assessed for imprecision across two reagent lots and compared with a reference laboratory method (Cobas e601) using 81 plasma samples. Method concordance was analyzed using Bland-Altman and Passing-Bablok regression. A user satisfaction survey evaluated its practicality in a clinical setting.Results: For the first reagent lot, a coefficient of variation (CV) of 2.81% was observed, while for the second reagent lot, the CV was 5.4%. Method comparison revealed strong concordance with the reference method for NT-proBNP values < 1,000 ng/L. However, a significant bias was observed for values > 1,000 ng/L in the first lot, resolved in the second. User satisfaction surveys highlighted ease of use. Additionally, implementing the LumiraDx® NT-proBNP Platform resulted in a significant reduction in turnaround time, with an estimated 49 min saved in result reporting.Conclusion: The LumiraDx® NT-proBNP POCT device demonstrates strong potential for HF management by combining rapid results, user-friendly operation, and sampling versatility. While biases at higher NT-proBNP levels warrant further standardization, this system represents a practical tool for decentralized HF care.","PeriodicalId":9424,"journal":{"name":"Cardiology Research","volume":"16 5","pages":"447-452"},"PeriodicalIF":1.3000,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12571134/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cardiology Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.14740/cr2117","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/10/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}

引用次数: 0

Abstract

Background: N-terminal pro-brain natriuretic peptide (NT-proBNP) is a key biomarker in heart failure (HF) diagnosis and management. This study aimed to evaluate performances of the LumiraDx^® NT-proBNP, a point-of-care testing (POCT) device, focusing on imprecision, method comparison, and clinical practicability.

Methods: The LumiraDx^® NT-proBNP test was assessed for imprecision across two reagent lots and compared with a reference laboratory method (Cobas e601) using 81 plasma samples. Method concordance was analyzed using Bland-Altman and Passing-Bablok regression. A user satisfaction survey evaluated its practicality in a clinical setting.

Results: For the first reagent lot, a coefficient of variation (CV) of 2.81% was observed, while for the second reagent lot, the CV was 5.4%. Method comparison revealed strong concordance with the reference method for NT-proBNP values < 1,000 ng/L. However, a significant bias was observed for values > 1,000 ng/L in the first lot, resolved in the second. User satisfaction surveys highlighted ease of use. Additionally, implementing the LumiraDx^® NT-proBNP Platform resulted in a significant reduction in turnaround time, with an estimated 49 min saved in result reporting.

Conclusion: The LumiraDx^® NT-proBNP POCT device demonstrates strong potential for HF management by combining rapid results, user-friendly operation, and sampling versatility. While biases at higher NT-proBNP levels warrant further standardization, this system represents a practical tool for decentralized HF care.

Abstract Image

查看原文本刊更多论文

评价护理点n端前脑利钠肽检测对心力衰竭管理的作用。

背景：n端前脑利钠肽（NT-proBNP）是心衰（HF）诊断和治疗的关键生物标志物。本研究旨在评估LumiraDx®NT-proBNP（一种POCT设备）的性能，重点关注不精确性、方法比较和临床实用性。方法：评估LumiraDx®NT-proBNP测试在两个试剂批次之间的不精确性，并与使用81个血浆样本的参考实验室方法（Cobas e601）进行比较。方法采用Bland-Altman回归和Passing-Bablok回归进行一致性分析。一项用户满意度调查评估了它在临床环境中的实用性。结果：第一批试剂的变异系数（CV）为2.81%，第二批试剂的变异系数为5.4%。方法比较显示NT-proBNP值< 1,000 ng/L与参考方法有较强的一致性。然而，在第一批样品中，观察到bb0 ~ 1,000 ng/L值存在显著偏差，在第二批样品中得到了解决。用户满意度调查强调了易用性。此外，实施LumiraDx®NT-proBNP平台显著缩短了周转时间，结果报告估计节省了49分钟。结论：LumiraDx®NT-proBNP POCT设备结合了快速结果、用户友好操作和取样通用性，在HF管理方面显示出强大的潜力。虽然较高NT-proBNP水平的偏差需要进一步标准化，但该系统代表了分散心衰护理的实用工具。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Cardiology Research CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

2.50

自引率

0.00%

发文量

期刊介绍： Cardiology Research is an open access, peer-reviewed, international journal. All submissions relating to basic research and clinical practice of cardiology and cardiovascular medicine are in this journal''s scope. This journal focuses on publishing original research and observations in all cardiovascular medicine aspects. Manuscript types include original article, review, case report, short communication, book review, letter to the editor.