Clinical Validation of a Novel High-Sensitivity Cardiac Troponin I Assay for Early Diagnosis of Acute Myocardial Infarction

• Published in: Clinical chemistry (Baltimore, Md.) Md.), 2018-09, Vol.64 (9), p.1347-1360
• Main Authors: Boeddinghaus, Jasper, Twerenbold, Raphael, Nestelberger, Thomas, Badertscher, Patrick, Wildi, Karin, Puelacher, Christian, du Fay de Lavallaz, Jeanne, Keser, Elif, Rubini Giménez, Maria, Wussler, Desiree, Kozhuharov, Nikola, Rentsch, Katharina, Miró, Òscar, Martin-Sanchez, F Javier, Morawiec, Beata, Stefanelli, Sabrina, Geigy, Nicolas, Keller, Dagmar I, Reichlin, Tobias, Mueller, Christian
• Format: Article
• Language: English
• Subjects: Accuracy; Acute coronary syndromes; Adjudication; Algorithms; Architects; Assaying; Calcium-binding protein; Cardiology; Diagnosis; Diagnostic systems; Electrocardiography; Emergency medical services; Heart; Heart attacks; Immunoassay; Kidney diseases; Laboratories; Medical diagnosis; Myocardial infarction; Patients; Population; Secondary analysis; Sensitivity; Troponin; Troponin I
• ISSN: 0009-9147; 1530-8561
• DOI: 10.1373/clinchem.2018.286906

Clinical performance of the novel high-sensitivity cardiac troponin I (Siemens-hs-cTnI-Centaur) assay is unknown. We aimed to clinically validate the Siemens-hs-cTnI-Centaur assay and develop 0/1-h and 0/2-h algorithms. 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 including all clinical information twice: first, using serial hs-cTnT (Roche-Elecsys, primary analysis); second, using hs-cTnI (Abbott-Architect, secondary analysis) measurements in addition to the clinically applied (hs)-cTn. Siemens-hs-cTnI-Centaur was measured at presentation, 1 h, and 2 h. The primary objective was a direct comparison of diagnostic accuracy, quantified by the area under the ROC curve (AUC), of Siemens-hs-cTnI-Centaur vs the 2 established hs-cTn assays (Roche-hs-cTnT-Elecsys, Abbott-hs-cTnI-Architect). Secondary objectives included the development of Siemens-hs-cTnI-Centaur-specific 0/1-h and 0/2-h algorithms. AMI was the final diagnosis in 318 of 1755 (18%) patients (using Roche-hs-cTnT-Elecsys for adjudication). The AUC at presentation for Siemens-hs-cTnI-Centaur was 0.94 (95% CI, 0.92-0.96) and comparable with 0.95 (95% CI, 0.93-0.97) for Roche-hs-cTnT-Elecsys and 0.93 (95% CI, 0.90-0.96) for Abbott-hs-cTnI-Architect. Applying the derived Siemens-hs-cTnI-Centaur 0/1-h algorithm to the validation cohort, 46% of patients were ruled out (sensitivity, 99.1%; 95% CI, 95.3-100), and 18% of patients were ruled in (specificity, 94.1%; 95% CI, 91.8-95.9). The Siemens-hs-cTnI-Centaur 0/2-h algorithm ruled out 55% of patients (sensitivity, 100%; 95% CI, 94.1-100), and ruled in 18% of patients (specificity, 96.0%; 95% CI, 93.1-97.9). Findings were confirmed in the secondary analyses using serial measurements of Abbott-hs-cTnI-Architect for adjudication. Diagnostic accuracy and clinical utility of the novel Siemens-hs-cTnI-Centaur assay are high and comparable with the established hs-cTn assays. ClinicalTrials.gov Identifier: NCT00470587.