title: Diagnostic accuracy of single baseline measurement of Elecsys Troponin T high-sensitive assay for diagnosis of acute myocardial infarction in emergency department: systematic review and meta-analysis.
abstract: OBJECTIVE
  To obtain summary estimates of the accuracy of a single baseline measurement of the Elecsys Troponin T high-sensitive assay (Roche Diagnostics) for the diagnosis of acute myocardial infarction in patients presenting to the emergency department.
  
  
  METHODS
  Systematic review and meta-analysis of diagnostic test accuracy studies.
  
  
  METHODS
  Medline, Embase, and other relevant electronic databases were searched for papers published between January 2006 and December 2013.
  
  
  METHODS
  Studies were included if they evaluated the diagnostic accuracy of a single baseline measurement of Elecsys Troponin T high-sensitive assay for the diagnosis of acute myocardial infarction in patients presenting to the emergency department with suspected acute coronary syndrome.
  The first author screened all titles and abstracts identified through the searches and selected all potentially relevant papers. The screening of the full texts, the data extraction, and the methodological quality assessment, using the adapted QUADAS-2 tool, were conducted independently by two reviewers with disagreements being resolved through discussion or arbitration. If appropriate, meta-analysis was conducted using the hierarchical bivariate model.
  
  
  RESULTS
  Twenty three studies reported the performance of the evaluated assay at presentation. The results for 14 ng/L and 3-5 ng/L cut-off values were pooled separately. At 14 ng/L (20 papers), the summary sensitivity was 89.5% (95% confidence interval 86.3% to 92.1%) and the summary specificity was 77.1% (68.7% to 83.7%). At 3-5 ng/L (six papers), the summary sensitivity was 97.4% (94.9% to 98.7%) and the summary specificity was 42.4% (31.2% to 54.5%). This means that if 21 of 100 consecutive patients have the target condition (21%, the median prevalence across the studies), 2 (95% confidence interval 2 to 3) of 21 patients with acute myocardial infarction will be missed (false negatives) if 14 ng/L is used as a cut-off value and 18 (13 to 25) of 79 patients without acute myocardial infarction will test positive (false positives). If the 3-5 ng/L cut-off value is used, <1 (0 to 1) patient with acute myocardial infarction will be missed and 46 (36 to 54) patients without acute myocardial infarction will test positive.
  
  
  CONCLUSIONS
  The results indicate that a single baseline measurement of the Elecsys Troponin T high-sensitive assay could be used to rule out acute myocardial infarction if lower cut-off values such as 3 ng/L or 5 ng/L are used. However, this method should be part of a comprehensive triage strategy and may not be appropriate for patients who present less than three hours after symptom onset. Care must also be exercised because of the higher imprecision of the evaluated assay and the greater effect of lot-to-lot reagent variation at low troponin concentrations.
  
  
  BACKGROUND
  PROSPERO registration number CRD42013003926.
authors: Institute of Health Research, University of Exeter Medical School, Exeter EX2 4SG, UK Z.Zhelev@exeter.ac.uk.
authors: Zhivko
authors: Z
authors: Zhelev
authors: Institute of Health Research, University of Exeter Medical School, Exeter EX2 4SG, UK.
authors: Christopher
authors: C
authors: Hyde
authors: Institute of Health Research, University of Exeter Medical School, Exeter EX2 4SG, UK.
authors: Emily
authors: E
authors: Youngman
authors: Institute of Health Research, University of Exeter Medical School, Exeter EX2 4SG, UK.
authors: Morwenna
authors: M
authors: Rogers
authors: Clinical Chemistry, Royal Cornwall Hospital, Treliske, Truro TR1 3LQ, UK.
authors: Simon
authors: S
authors: Fleming
authors: Emergency Department, Royal Cornwall Hospital, Truro TR1 3LJ, UK.
authors: Toby
authors: T
authors: Slade
authors: Institute of Health Research, University of Exeter Medical School, Exeter EX2 4SG, UK.
authors: Helen
authors: H
authors: Coelho
authors: Institute of Health Research, University of Exeter Medical School, Exeter EX2 4SG, UK.
authors: Tracey
authors: T
authors: Jones-Hughes
authors: Institute of Health Research, University of Exeter Medical School, Exeter EX2 4SG, UK.
authors: Vasilis
authors: V
authors: Nikolaou
mesh_terms: D015415:Biomarkers / Q000097:blood; D004636:Emergency Service, Hospital; D006801:Humans; D009203:Myocardial Infarction / Q000097:blood*; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D020107:Troponin T / Q000097:blood*
chemical_list: D015415:Biomarkers; D020107:Troponin T
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