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即时检测高敏心肌肌钙蛋白I检测法对急性冠状动脉综合征的排除和诊断性能及单次测量评估

Diagnostic performance of a point of care high-sensitivity cardiac troponin I assay and single measurement evaluation to rule out and rule in acute coronary syndrome.

作者信息

De Iuliis Vincenzo, Gabriele Anna Rita, De Santis Francesca, De Rugeriis Roberta, Di Quinzio Luigi, Aloisi Steeve, Rosati Anna Carla, Benvenuto Manuela, Fabiani Donatello, Chiatamone Ranieri Sofia

机构信息

Department of Clinical Pathology, 92708 G. Mazzini Civil Hospital , Teramo, Italy.

Emergency Department, 92708 G. Mazzini Civil Hospital , Teramo, Italy.

出版信息

Clin Chem Lab Med. 2024 Apr 29;62(11):2326-2334. doi: 10.1515/cclm-2024-0225. Print 2024 Oct 28.

DOI:10.1515/cclm-2024-0225
PMID:38669209
Abstract

OBJECTIVES

About 10 million individuals in USA presented annually in the emergency department (ED) with chest pain or with signs and symptoms of acute coronary syndrome (ACS). The advent of point of care (POC) devices, able to measure high sensitivity troponin, are a very interesting tool in the ED setting for its rapid turnaround time (<10 min).

METHODS

The present study evaluates the diagnostic performance of the Atellica VTLi (Siemens) in real life setting using the clinical data derived from integrated diagnoses of emergency room staff and cardiologist and in comparison with standard laboratory hs-cTnT assay (Cobas 8000, Elecsys, Roche). 966 patients admitted to the emergency department of "G. Mazzini Hospital" in Teramo, Italy, from July 27, 2022, through June 09, 2023, were enrolled.

RESULTS

The diagnostic performance of POC hs-cTnI was evaluated. An appropriate POC hs-cTnI threshold values <4 ng/L supplied a sensitivity and an NPV of 100 % (95 % CI: 99.5-100) in order to achieve rapid rule out for MI through a single measurement at patient presentation in the ED. Furthermore, a derivation POC hs-cTnI concentration >54 ng/L provided a specificity of 97.2 % (95 % CI: 95.9-98.1) and a PPV of 43.5 % (95 % CI: 40.3-46.7) for ruling in MI.

CONCLUSIONS

This platform showed comparable diagnostic performance for myocardial infarction to the central laboratory. Our data suggest the possible use of the Atellica VTLi hs-cTnI POC assay either in emergency department of urban medical centre, either in rural hospital for triage and patient management.

摘要

目的

美国每年约有1000万人因胸痛或急性冠状动脉综合征(ACS)的体征和症状前往急诊科就诊。即时检测(POC)设备能够测量高敏肌钙蛋白,因其周转时间短(<10分钟),在急诊科环境中是一种非常有趣的工具。

方法

本研究使用来自急诊室工作人员和心脏病专家综合诊断的临床数据,在实际环境中评估Atellica VTLi(西门子)的诊断性能,并与标准实验室高敏肌钙蛋白T检测(Cobas 8000,Elecsys,罗氏)进行比较。纳入了2022年7月27日至2023年6月9日期间在意大利特拉莫的“G. 马齐尼医院”急诊科就诊的966例患者。

结果

评估了POC高敏肌钙蛋白I的诊断性能。适当的POC高敏肌钙蛋白I阈值<4 ng/L时,灵敏度和阴性预测值为100%(95% CI:99.5 - 100),以便在急诊科患者就诊时通过单次测量快速排除心肌梗死。此外,推导的POC高敏肌钙蛋白I浓度>54 ng/L时,诊断心肌梗死的特异性为97.2%(95% CI:9

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