title: Point of Care Cardiac Troponin Assay Analytical Performances for their Use in Clinical Routine.
abstract: BACKGROUND
  We report the analytical and clinical performances of the Alere Triage Cardiac3© Panel on the Triage MeterPro© instrument, comparing concordance with hs-cTnT results from central laboratory above the respective 99th percentiles and determining the clinical sensitivity within the framework of AMI.
  
  
  METHODS
  The concordance was obtained with these two methods among unselected patients admitted to both the emergency and cardiology departments.
  
  
  RESULTS
  The LoD of the assay is 0.010 µg/L. At 99th percentile (0.02 µg/L) the CV was found to be 18%, below the clinically acceptable cutoff of 20%. In the overall population, ROC AUC was not significantly different between the central laboratory assay and POC assay, with 0.952 (95% CI, 0.918 - 0.952) for hs-cTnT concentrations at presentation and 0.953 (95% CI, 0.912 - 0.953) for cTnI. Sensitivity and specificity of hs-cTnT vs. cTnI for AMI (n = 32) were 97% and 78% vs. 91% and 86%, respectively. Our results indicated 90.4% concordance between the two methods using the 99th percentile specific for each assay. The Kappa coefficient was higher than 0.75, and the strength of agreement could be considered to be good.
  
  
  CONCLUSIONS
  The results of cTnI Alere assays provide similar clinical classification of patients, particularly for the AMI group as compared to the central laboratory hs-cTnT assay and could be suitable for clinical in accordance with the recommendations of Global Task Force guidelines.
authors.forename: Anne M
authors.initials: AM
authors.lastname: Dupuy
authors.forename: Solenne
authors.initials: S
authors.lastname: Baillet
authors.forename: Richard
authors.initials: R
authors.lastname: Dumont
authors.forename: Isabelle
authors.initials: I
authors.lastname: Giraud
authors.forename: Stephanie
authors.initials: S
authors.lastname: Badiou
authors.forename: Anne S
authors.initials: AS
authors.lastname: Bargnoux
authors.forename: Nils
authors.initials: N
authors.lastname: Kuster
authors.forename: Francois
authors.initials: F
authors.lastname: Roubille
authors.forename: Jean Paul
authors.initials: JP
authors.lastname: Cristol
mesh_terms: D015415:Biomarkers; D006801:Humans; D009203:Myocardial Infarction; D019095:Point-of-Care Systems; D014218:Triage; D019210:Troponin I; D020107:Troponin T
chemical_list: D015415:Biomarkers; D019210:Troponin I; D020107:Troponin T