高灵敏度心肌肌钙蛋白 I 检测和单次测量评估在排除和诊断急性冠状动脉综合征方面的诊断性能

IF 3.8 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Clinical chemistry and laboratory medicine Pub Date : 2024-04-26 DOI:10.1515/cclm-2024-0225
Vincenzo De Iuliis, Anna Rita Gabriele, Francesca De Santis, Roberta De Rugeriis, Luigi Di Quinzio, Steeve Aloisi, Anna Carla Rosati, Manuela Benvenuto, Donatello Fabiani, Sofia Chiatamone Ranieri
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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. 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引用次数: 0

摘要

目的 美国每年约有 1,000 万人因胸痛或伴有急性冠状动脉综合症(ACS)的症状和体征而到急诊科就诊。能够测量高灵敏度肌钙蛋白的护理点(POC)设备的出现因其快速的周转时间(10 分钟)而成为急诊科中非常有趣的工具。方法 本研究利用急诊室工作人员和心脏病专家综合诊断得出的临床数据,并与标准实验室 hs-cTnT 检测方法(Cobas 8000,Elecsys,罗氏)进行比较,评估 Atellica VTLi(西门子)在现实生活中的诊断性能。从 2022 年 7 月 27 日至 2023 年 6 月 9 日,意大利泰拉莫 G. Mazzini 医院急诊科收治了 966 名患者。结果 评估了 POC hs-cTnI 的诊断性能。合适的 POC hs-cTnI 阈值为 4 ng/L,灵敏度和 NPV 均为 100%(95% CI:99.5-100),可在急诊室患者就诊时通过一次测量快速排除心肌梗死。此外,推导 POC hs-cTnI 浓度为 54 纳克/升时,排除心肌梗死的特异性为 97.2%(95% CI:95.9-98.1),PPV 为 43.5%(95% CI:40.3-46.7)。结论 该平台对心肌梗死的诊断性能与中心实验室相当。我们的数据表明,Atellica VTLi hs-cTnI POC 检测仪既可用于城市医疗中心的急诊科,也可用于农村医院的分诊和患者管理。
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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
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.
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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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