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.
Applying High-Sensitivity Cardiac Troponin T Glarner, Noemi; Lopez-Ayala, Pedro; Cakal, Hatice ...
Journal of the American College of Cardiology,
11/2021, Letnik:
78, Številka:
18
Journal Article
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