Clinical performance of a new point-of-care cardiac troponin I test - Christ, M.; Geier, F.; Blaschke, S.; Giannitsis, E.; Khellaf, M.; Mair, J.; Pariente, D.; Scharnhorst, V.; Semjonow, V.; Hausfater, P. (Clin Chem Lab Med, 2018)
BACKGROUND: We evaluated the clinical performance of the Minicare cardiac troponin-I (cTnI), a new point-of-care (POC) cTnI test for the diagnosis of acute myocardial infarction (AMI) in a prospective, multicentre study (ISRCTN77371338). METHODS: Of 474 patients (>/=18 years) admitted to an emergency department (ED) or chest pain unit (CPU) with symptoms suggestive of acute coronary syndrome (ACS; </=12 h from symptom onset), 465 were eligible. Minicare cTnI was tested immediately, 3 h and 6 h after presentation. AMI diagnoses were adjudicated independently based on current guidelines. RESULTS: The diagnostic performance of the Minicare cTnI test at 3 h was similar for whole blood and in plasma: sensitivity 0.92 vs. 0.90; specificity 0.91 vs. 0.90; positive predictive value (PPV) 0.68 vs. 0.66; negative predictive value (NPV) 0.98 vs. 0.98; positive likelihood ratio (LR+) 10.18 vs. 9.41; negative likelihood ratio (LR-) 0.09 vs. 0.11. The optimal diagnostic performance was obtained at 3 h using cut-offs cTnI >43 ng/L plus cTnI change from admission >/=18.5 ng/L: sensitivity 0.90, specificity 0.96, PPV 0.81, NPV 0.98, and LR+ 21.54. The area under the receiver operating characteristics (ROC) curve for cTnI whole blood baseline value and absolute change after 3 h curve was 0.93. CONCLUSIONS: These data support the clinical usefulness of Minicare cTnI within a 0 h/3 h-blood sampling protocol supported by current guidelines for the evaluation of suspected ACS.
Keywords: journalArticle; Aged; Biomarkers/*blood; Blood Chemical Analysis/instrumentation/*methods; False Negative Reactions; Female; Humans; Male; Middle Aged; Myocardial Infarction/diagnosis; Point-of-Care Testing; Prospective Studies; ROC Curve; Single-Blind Method; Troponin I/*blood; acute coronary syndrome; cardiac biomarkers; cardiac troponin I; emergency medicine; myocardial infarction; non-ST-elevation myocardial infarction; point-of-care; troponin