Send to

Choose Destination
Clin Chem. 2019 Jul;65(7):893-904. doi: 10.1373/clinchem.2018.300061. Epub 2019 Apr 15.

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

Author information

Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland.
Division of Internal Medicine, University Hospital Basel, University of Basel, Basel, Switzerland.
GREAT network.
Department of Cardiac Surgery, University Hospital Basel, University of Basel, Switzerland.
Division of Cardiology, University of Illinois at Chicago, Chicago, IL.
Emergency Department, Hospital Clinic, Barcelona, Catalonia, Spain.
Servicio de Urgencias, Hospital Clínico San Carlos, Madrid, Spain.
Emergency Department, University Hospital Zurich, Zurich, Switzerland.
Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.
Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Basel, Switzerland;



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; 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.


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. Identifier: NCT00470587.

Supplemental Content

Full text links

Icon for HighWire
Loading ...
Support Center