Clinical Use of a New High-Sensitivity Cardiac Troponin I Assay in Patients with Suspected Myocardial Infarction

Boeddinghaus, Jasper and Twerenbold, Raphael and Nestelberger, Thomas and Koechlin, Luca and Wussler, Desiree and Meier, Mario and Troester, Valentina and Zimmermann, Tobias and Badertscher, Patrick and Wildi, Karin and Rubini Giménez, Maria and Lopez-Ayala, Pedro and Potlukova, Eliska and Miró, Òscar and Martin-Sanchez, F. Javier and Kawecki, Damian and Geigy, Nicolas and Keller, Dagmar I. and Reichlin, Tobias and Mueller, Christian and Apace investigators, . (2019) Clinical Use of a New High-Sensitivity Cardiac Troponin I Assay in Patients with Suspected Myocardial Infarction. Clinical Chemistry, 65 (11). pp. 1426-1436.

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Official URL: https://edoc.unibas.ch/76997/

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We aimed to validate the clinical performance of the high-sensitivity cardiac troponin I [VITROS; ®; Immunodiagnostic Products hs Troponin I (hs-cTnI-VITROS)] assay.; 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 considering all clinical information, including cardiac imaging: first, using serial hs-cTnT-Elecsys (primary analysis) and, second, using hs-cTnI-Architect (secondary analysis) measurements in addition to the clinically used (hs)-cTn. hs-cTnI-VITROS was measured at presentation and at 1 h in a blinded fashion. The primary objective was direct comparison of diagnostic accuracy as quantified by the area under the ROC curve (AUC) of hs-cTnI-VITROS vs hs-cTnT-Elecsys and hs-cTnI-Architect, and in a subgroup also hs-cTnI-Centaur and hs-cTnI-Access. Secondary objectives included the derivation and validation of an hs-cTnI-VITROS-0/1-h algorithm.; AMI was the adjudicated final diagnosis in 158 of 1231 (13%) patients. At presentation, the AUC for hs-cTnI-VITROS was 0.95 (95% CI, 0.93-0.96); for hs-cTnT-Elecsys, 0.94 (95% CI, 0.92-0.95); and for hs-cTnI-Architect, 0.92 (95% CI, 0.90-0.94). AUCs for hs-cTnI-Centaur and hs-cTnI-Access were 0.95 (95% CI, 0.94-0.97). Applying the derived hs-cTnI-VITROS-0/1-h algorithm (derivation cohort n = 519) to the validation cohort (n = 520), 53% of patients were ruled out [sensitivity, 100% (95% CI, 94.1-100)] and 14% of patients were ruled in [specificity, 95.6% (95% CI, 93.4-97.2)]. Patients ruled out by the 0/1-h algorithm had a survival rate of 99.8% at 30 days. Findings were confirmed in the secondary analyses using the adjudication including serial measurements of hs-cTnI-Architect.; The hs-cTnI-VITROS assay has at least comparable diagnostic accuracy with the currently best validated hs-cTnT and hs-cTnI assays.; 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:Boeddinghaus, Jasper and Twerenbold, Raphael and Müller, Christian
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:American Association for Clinical Chemistry
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:11 Nov 2020 15:29
Deposited On:01 Jul 2020 07:17

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