• Medientyp: E-Artikel
  • Titel: High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction
  • Beteiligte: 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; Mueller, Christian; Walter, Joan Elias; Strebel, Ivo; Kozhuharov, Nikola; Freese, Michael; [...]
  • Erschienen: Oxford University Press (OUP), 2019
  • Erschienen in: Clinical Chemistry
  • Umfang: 893-904
  • Sprache: Englisch
  • DOI: 10.1373/clinchem.2018.300061
  • ISSN: 0009-9147; 1530-8561
  • Schlagwörter: Biochemistry (medical) ; Clinical Biochemistry
  • Zusammenfassung: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>BACKGROUND</jats:title> <jats:p>The aim of this study was to validate the clinical performance of the Beckman Access high-sensitivity cardiac troponin I (hs-cTnI) assay.</jats:p> </jats:sec> <jats:sec> <jats:title>METHODS</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>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 &amp;lt; 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.</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>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.</jats:p> </jats:sec>
  • Beschreibung: <jats:title>Abstract</jats:title>
    <jats:sec>
    <jats:title>BACKGROUND</jats:title>
    <jats:p>The aim of this study was to validate the clinical performance of the Beckman Access high-sensitivity cardiac troponin I (hs-cTnI) assay.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>METHODS</jats:title>
    <jats:p>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.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>RESULTS</jats:title>
    <jats:p>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 &amp;lt; 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.</jats:p>
    </jats:sec>
    <jats:sec>
    <jats:title>CONCLUSIONS</jats:title>
    <jats:p>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.</jats:p>
    </jats:sec>
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