Clinical Laboratory Validation Study of a High Sensitivity Troponin I Assay on a POCT (Point of Care Testing) Device.

IF 3 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Global Heart Pub Date : 2024-12-18 eCollection Date: 2024-01-01 DOI:10.5334/gh.1377

Fabio Grunspun Pitta, Adriana Caschera Leme, Simone Rodrigues Gomes, Tarsila Perez Mota, Fernanda Vieira Paladino, José Leão de Souza Júnior, Rosemeire de Paula Braz, Thais Cristine Rodrigues Leonel Lamounier, Jéssica Buzin Gomes Ferreira, Carlos Eduardo Dos Santos Ferreira

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引用次数: 0

Abstract

Background: In Acute Coronary Syndrome without ST-segment elevation, the use of high-sensitivity troponins in rapid protocols is considered the gold standard for diagnostic exclusion/confirmation, in conjunction with clinical stratification. The biggest concern regarding the techniques for troponin evaluation is the time required between collection and delivery of the result.

Objective: The objective of the present study is the clinical/laboratory validation of a POCT device for TnI.

Methods: In the first phase of the study, samples from 108 patients with known troponin values High Sensitivity Automated Troponin T (TnT) assay from Roche Diagnostics were analyzed for analytical comparability between hs-cTnI of the Analyzer Atellica® vTLi and hs-cTnT Cobas®. The second phase of the study was performed with samples from 51 patients who reported to the emergency department with chest pain for a clinical prospective evaluation and correlation between the hs-cTnI assays of the Analyzer Atellica® vTLi, hs-cTnT Cobas® and Atellica IM 1300.

Results: There was a correlation between the POCT Atellica® vTLi and hs-cTnT Cobas® in the serum samples of the control group (r = 0.660, p < 0.0001). Besides, there was a correlation between the Atellica® vTLi, serum hs-cTnT Cobas®, plasma hs-cTnT Cobas®, serum Atellica IM and plasma Atellica IM 1300 platforms in the second phase (p < 0.0001 in all cases).

Conclusion: In the present study, the Siemens POCT Atellica® vTLi device showed excellent performance in laboratory validation and correlation with the high-sensitivity TnT assay in different troponin concentration ranges. Given these results, the device can be used in institutions that intend to use a POCT device for 0- and 1-hour chest pain protocols.

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POCT（护理点检测）设备上高灵敏度肌钙蛋白I检测的临床实验室验证研究。

背景：在无st段抬高的急性冠状动脉综合征中，结合临床分层，在快速方案中使用高灵敏度肌钙蛋白被认为是诊断排除/确认的金标准。关于肌钙蛋白评估技术的最大问题是收集和交付结果之间所需的时间。目的：本研究的目的是临床/实验室验证POCT装置治疗TnI。方法：在研究的第一阶段，对来自罗氏诊断公司的108例已知肌钙蛋白值高灵敏度自动肌钙蛋白T （TnT）测定的患者样本进行分析，以确定Atellica®vTLi分析仪的hs-cTnI与hs-cTnT Cobas®的分析可比性。该研究的第二阶段是对51例因胸痛向急诊科报告的患者的样本进行临床前瞻性评估，并分析Atellica®vTLi、hs-cTnT Cobas®和Atellica IM 1300分析仪的hs-cTnI检测之间的相关性。结果：对照组血清样品中POCT Atellica®vTLi与hs-cTnT Cobas®存在相关性（r = 0.660, p < 0.0001）。Atellica®vTLi、血清hs-cTnT Cobas®、血浆hs-cTnT Cobas®、血清Atellica IM和血浆Atellica IM 1300平台在二期均存在相关性（p < 0.0001）。结论：在本研究中，西门子POCT Atellica®vTLi装置在不同肌钙蛋白浓度范围内具有良好的实验室验证和与高灵敏度TnT检测的相关性。鉴于这些结果，该设备可用于打算使用POCT设备治疗0小时和1小时胸痛的机构。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Global Heart Medicine-Cardiology and Cardiovascular Medicine

CiteScore

5.70

自引率

5.40%

发文量

审稿时长

5 weeks

期刊介绍： Global Heart offers a forum for dialogue and education on research, developments, trends, solutions and public health programs related to the prevention and control of cardiovascular diseases (CVDs) worldwide, with a special focus on low- and middle-income countries (LMICs). Manuscripts should address not only the extent or epidemiology of the problem, but also describe interventions to effectively control and prevent CVDs and the underlying factors. The emphasis should be on approaches applicable in settings with limited resources. Economic evaluations of successful interventions are particularly welcome. We will also consider negative findings if important. While reports of hospital or clinic-based treatments are not excluded, particularly if they have broad implications for cost-effective disease control or prevention, we give priority to papers addressing community-based activities. We encourage submissions on cardiovascular surveillance and health policies, professional education, ethical issues and technological innovations related to prevention. Global Heart is particularly interested in publishing data from updated national or regional demographic health surveys, World Health Organization or Global Burden of Disease data, large clinical disease databases or registries. Systematic reviews or meta-analyses on globally relevant topics are welcome. We will also consider clinical research that has special relevance to LMICs, e.g. using validated instruments to assess health-related quality-of-life in patients from LMICs, innovative diagnostic-therapeutic applications, real-world effectiveness clinical trials, research methods (innovative methodologic papers, with emphasis on low-cost research methods or novel application of methods in low resource settings), and papers pertaining to cardiovascular health promotion and policy (quantitative evaluation of health programs.