High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction.

Boeddinghaus, Jasper; Nestelberger, Thomas; Twerenbold, Raphael; Koechlin, Luca; Meier, Mario; Troester, Valentina; Wussler, Desiree; Badertscher, Patrick; Wildi, Karin; Puelacher, Christian; du Fay de Lavallaz, Jeanne; Rubini Giménez, Maria; Zimmermann, Tobias; Hafner, Benjamin; Potlukova, Eliska; Miró, Òscar; Martin-Sanchez, F Javier; Keller, Dagmar I; Reichlin, Tobias and Mueller, Christian (2019). High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction. Clinical chemistry, 65(7), pp. 893-904. American Association for Clinical Chemistry 10.1373/clinchem.2018.300061

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BACKGROUND The aim of this study was to validate the clinical performance of the Beckman Access high-sensitivity cardiac troponin I (hs-cTnI) assay. METHODS 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 with all clinical information including cardiac imaging twice: 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 Access was measured at presentation and at 1 h. The primary objective was a direct comparison of diagnostic accuracy as quantified by the area under the ROC curve (AUC) of hs-cTnI Access vs the hs-cTnT Elecsys and hs-cTnI Architect assays. Secondary objectives included the derivation and validation of an hs-cTnI Access-specific 0/1-h algorithm. RESULTS AMI was the adjudicated final diagnosis in 243 of 1579 (15.4%) patients. The AUC at presentation for hs-cTnI Access was 0.95 (95% CI, 0.94-0.96), higher than hs-cTnI Architect [0.92 (95% CI, 0.91-0.94; P < 0.001)] and comparable to hs-cTnT Elecsys [0.94 (95% CI, 0.93-0.95; P = 0.12)]. Applying the derived hs-cTnI Access 0/1-h algorithm (derivation cohort n = 686) to the validation cohort (n = 680), 60% of patients were ruled out [sensitivity, 98.9% (95% CI, 94.3-99.8)], and 15% of patients were ruled in [specificity, 95.9% (95% CI, 94.0-97.2)]. Patients ruled out by the 0/1-h algorithm had a survival rate of 100% at 30 days. Findings were confirmed in the secondary analyses by the adjudication including serial measurements of Architect hs-cTnI. CONCLUSIONS Diagnostic accuracy and clinical utility of the Beckman hs-cTnI Access assay are very high and at least comparable to Roche hs-cTnT and Abbott hs-cTnI assays. ClinicalTrials.gov Identifier: NCT00470587.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Reichlin, Tobias Roman

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0009-9147

Publisher:

American Association for Clinical Chemistry

Language:

English

Submitter:

Daria Vogelsang

Date Deposited:

11 Dec 2019 07:08

Last Modified:

11 Dec 2019 07:08

Publisher DOI:

10.1373/clinchem.2018.300061

PubMed ID:

30988172

URI:

https://boris.unibe.ch/id/eprint/134546

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