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

• Published in: Clinical chemistry (Baltimore, Md.) Vol. 65; no. 7; pp. 893 - 904
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01.07.2019
• Subjects: Accuracy; Acute coronary syndromes; Adjudication; Aged; Aged, 80 and over; Algorithms; Angina pectoris; Architects; Area Under Curve; Assaying; Biomarkers - blood; Calcium-binding protein; Cardiology; Derivation; Diagnosis; Diagnostic systems; Early Diagnosis; Electrocardiography; Emergency medical services; Female; Heart; Heart attacks; Humans; Laboratories; Male; Medical diagnosis; Medical imaging; Middle Aged; Myocardial infarction; Myocardial Infarction - blood; Myocardial Infarction - diagnosis; Patients; Prospective Studies; ROC Curve; Secondary analysis; Sensitivity; Signs and symptoms; Survival; Troponin; Troponin I; Troponin I - blood; Troponin T - blood
• ISSN: 0009-9147; 1530-8561
• DOI: 10.1373/clinchem.2018.300061

The aim of this study was to validate the clinical performance of the Beckman Access high-sensitivity cardiac troponin I (hs-cTnI) 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 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. 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; < 0.001)] and comparable to hs-cTnT Elecsys [0.94 (95% CI, 0.93-0.95; = 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. 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. NCT00470587.