title: Use of the bioMérieux VIDAS troponin I ultra assay for the diagnosis of myocardial infarction and detection of adverse events in patients presenting with symptoms suggestive of acute coronary syndrome.
abstract: BACKGROUND
  We demonstrate the performance of the bioMérieux VIDAS Troponin I Ultra assay for diagnostic accuracy for detection of myocardial infarction (MI) and risk stratification.
  
  
  METHODS
  cTnI was measured in 545 patients from 2 clinical centers with symptoms suggestive of ACS at admission, with an additional specimen at 4-12 h (453 patients). The 99th percentile value (0.01 microg/l) was used to assess clinical accuracy for diagnosis of acute MI. Primary endpoint for risk stratification was first of cardiac event or death in 302 patients (one center) followed for 60 days.
  
  
  RESULTS
  157 (28.8%) patients ruled in for an MI during index hospitalization. Sensitivities and specificities were 88.1% (95% CI 81.9 to 92.4%) and 79.9% (CI 75.5 to 83.6%) for baseline and 100% (CI 96.5 to 100%) and 79.4% (CI 74.4 to 83.4%) for follow-up specimens. ROC curve areas increased from 0.912 (CI 0.879 to 0.944) at baseline to 0.994 (CI 0.988 to 0.999) at second sampling (n=453, p<0.01); with no differences between sites. Primary endpoint rate for the 223 patients (74%) with normal cTnI on presentation was lower than the 79 patients (26%) with cTnI>0.01 ug/l (5.9% vs. 42.3%, p<0.0001). The relative risk for the >0.01 ug/l group was 8.9 (CI 4.6 to 17).
  
  
  CONCLUSIONS
  The VIDAS cTnI assay is a sensitive diagnostic method for the early detection of MI and predicts increased risk for adverse events in patients with symptoms suggestive of ACS.
authors.affiliation: Department of Laboratory Medicine and Pathology, Hennepin County Medical Center, University of Minnesota School of Medicine, Minneapolis, MN, USA. apple004@umn.edu
authors.forename: Fred S
authors.initials: FS
authors.lastname: Apple
authors.forename: Stephen W
authors.initials: SW
authors.lastname: Smith
authors.forename: Lesly A
authors.initials: LA
authors.lastname: Pearce
authors.forename: Ranka
authors.initials: R
authors.lastname: Ler
authors.forename: Maryann M
authors.initials: MM
authors.lastname: Murakami
authors.forename: Marie-Odile
authors.initials: MO
authors.lastname: Benoit
authors.forename: Camille
authors.initials: C
authors.lastname: Levy
authors.forename: Catherine
authors.initials: C
authors.lastname: Dumas
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Paul
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis* / Q000503:physiopathology; D004562:Electrocardiography; D006801:Humans; D009203:Myocardial Infarction / Q000175:diagnosis* / Q000503:physiopathology; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D019210:Troponin I / Q000097:blood*
chemical_list: D019210:Troponin I