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
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Vincenzo De Iuliis
, Anna Rita Gabriele
, Francesca De Santis , Roberta De Rugeriis , Luigi Di Quinzio , Steeve Aloisi , Anna Carla Rosati , Manuela Benvenuto , Donatello Fabiani und Sofia Chiatamone Ranieri
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.
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Research ethics: The study was conducted in accordance with the Declaration of Helsinki.
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Informed consent: Not applicable.
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Author contributions: The authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: The authors state no conflict of interest.
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Research funding: None declared.
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Data availability: The raw data can be obtained on request from the corresponding author.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2024-0225).
© 2024 Walter de Gruyter GmbH, Berlin/Boston
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Artikel in diesem Heft
- Frontmatter
- Editorial
- Circulating tumor DNA measurement: a new pillar of medical oncology?
- Reviews
- Circulating tumor DNA: current implementation issues and future challenges for clinical utility
- Circulating tumor DNA methylation: a promising clinical tool for cancer diagnosis and management
- Opinion Papers
- The final part of the CRESS trilogy – how to evaluate the quality of stability studies
- The impact of physiological variations on personalized reference intervals and decision limits: an in-depth analysis
- Computational pathology: an evolving concept
- Perspectives
- Dynamic mirroring: unveiling the role of digital twins, artificial intelligence and synthetic data for personalized medicine in laboratory medicine
- General Clinical Chemistry and Laboratory Medicine
- Macroprolactin in mothers and their babies: what is its origin?
- The influence of undetected hemolysis on POCT potassium results in the emergency department
- Quality control in the Netherlands; todays practices and starting points for guidance and future research
- QC Constellation: a cutting-edge solution for risk and patient-based quality control in clinical laboratories
- OILVEQ: an Italian external quality control scheme for cannabinoids analysis in galenic preparations of cannabis oil
- Using Bland-Altman plot-based harmonization algorithm to optimize the harmonization for immunoassays
- Comparison of a two-step Tempus600 hub solution single-tube vs. container-based, one-step pneumatic transport system
- Evaluating the HYDRASHIFT 2/4 Daratumumab assay: a powerful approach to assess treatment response in multiple myeloma
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- Reference Values and Biological Variations
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- Corrigendum
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- Letters to the Editor
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- Validation of the enhanced liver fibrosis (ELF)-test in heparinized and EDTA plasma for use in reflex testing algorithms for metabolic dysfunction-associated steatotic liver disease (MASLD)
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