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Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction

Boeddinghaus, Jasper and Twerenbold, Raphael and Nestelberger, Thomas and Badertscher, Patrick and Wildi, Karin and Puelacher, Christian and du Fay de Lavallaz, Jeanne and Keser, Elif and Rubini Giménez, Maria and Wussler, Desiree and Kozhuharov, Nikola and Rentsch, Katharina and Miró, Òscar and Martin-Sanchez, F. Javier and Morawiec, Beata and Stefanelli, Sabrina and Geigy, Nicolas and Keller, Dagmar I. and Reichlin, Tobias and Mueller, Christian and Apace Investigators, . (2018) Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction. Clinical chemistry, 64 (9). pp. 1347-1360.

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Official URL: https://edoc.unibas.ch/71168/

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Abstract

Clinical performance of the novel high-sensitivity cardiac troponin I (Siemens-hs-cTnI-Centaur) assay is unknown. We aimed to clinically validate the Siemens-hs-cTnI-Centaur assay and develop 0/1-h and 0/2-h algorithms.; We enrolled patients presenting to the emergency department with symptoms suggestive of acute myocardial infarction (AMI). Final diagnoses were centrally adjudicated by 2 independent cardiologists including all clinical information twice: first, using serial hs-cTnT (Roche-Elecsys, primary analysis); second, using hs-cTnI (Abbott-Architect, secondary analysis) measurements in addition to the clinically applied (hs)-cTn. Siemens-hs-cTnI-Centaur was measured at presentation, 1 h, and 2 h. The primary objective was a direct comparison of diagnostic accuracy, quantified by the area under the ROC curve (AUC), of Siemens-hs-cTnI-Centaur vs the 2 established hs-cTn assays (Roche-hs-cTnT-Elecsys, Abbott-hs-cTnI-Architect). Secondary objectives included the development of Siemens-hs-cTnI-Centaur-specific 0/1-h and 0/2-h algorithms.; AMI was the final diagnosis in 318 of 1755 (18%) patients (using Roche-hs-cTnT-Elecsys for adjudication). The AUC at presentation for Siemens-hs-cTnI-Centaur was 0.94 (95% CI, 0.92-0.96) and comparable with 0.95 (95% CI, 0.93-0.97) for Roche-hs-cTnT-Elecsys and 0.93 (95% CI, 0.90-0.96) for Abbott-hs-cTnI-Architect. Applying the derived Siemens-hs-cTnI-Centaur 0/1-h algorithm to the validation cohort, 46% of patients were ruled out (sensitivity, 99.1%; 95% CI, 95.3-100), and 18% of patients were ruled in (specificity, 94.1%; 95% CI, 91.8-95.9). The Siemens-hs-cTnI-Centaur 0/2-h algorithm ruled out 55% of patients (sensitivity, 100%; 95% CI, 94.1-100), and ruled in 18% of patients (specificity, 96.0%; 95% CI, 93.1-97.9). Findings were confirmed in the secondary analyses using serial measurements of Abbott-hs-cTnI-Architect for adjudication.; Diagnostic accuracy and clinical utility of the novel Siemens-hs-cTnI-Centaur assay are high and comparable with the established hs-cTn assays. ClinicalTrials.gov Identifier: NCT00470587.
Faculties and Departments:03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Kardiologie > Klinische Outcomeforschung Kardiologie (Müller)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Kardiologie > Klinische Outcomeforschung Kardiologie (Müller)
UniBasel Contributors:Müller, Christian
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:American Association for Clinical Chemistry
ISSN:0009-9147
e-ISSN:1530-8561
Note:Publication type according to Uni Basel Research Database: Journal article
Language:English
Identification Number:
Last Modified:05 Jul 2019 13:15
Deposited On:05 Jul 2019 13:15

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