title: Equal clinical performance of a novel point-of-care cardiac troponin I (cTnI) assay with a commonly used high-sensitivity cTnI assay.
abstract: BACKGROUND
  Efficient rule-out of acute myocardial infarction (MI) facilitates early disposition of chest pain patients in emergency departments (ED). Point-of-care (POC) cardiac troponin (cTn) may improve patient throughput. We compared the diagnostic accuracy of a novel cTnI test (Minicare cTnI, Philips), with current POC cTnI (I-Stat, Abbott) and high-sensitivity central laboratory cTnI (hs-cTnI; Architect, Abbott) assays.
  
  
  METHODS
  The clinical performance of the assays were compared in samples from 450 patients from a previous clinical evaluation of Minicare cTnI.
  
  
  RESULTS
  Minicare cTnI correlated with Architect hs-cTnI (r2=0.85, p<0.0001) and I-Stat cTnI (r2=0.93, p<0.0001). Areas under the receiver operating characteristics curves were 0.87-0.91 at admission (p=ns) and 0.96-0.97 3h after admission (p=ns). The negative predictive values (NPV) at admission were 95% ((92-97%, 95% CI) for Minicare cTnI and increased to 99% (97-100%) at 2-4h, and similar to Architect hs-cTnI (98%, 96-100%), but higher than I-Stat cTnI (95%, 92-97%; p<0.01). Negative likelihood ratios (LR-) after 2-4h were 0.06 (0.02-0.17, 95% CI) for Minicare cTnI, 0.11 (0.05-0.24) for Architect hs-cTnI (p=0.02) and 0.28 (0.18-0.43) for I-Stat cTnI (p<0.0001). The clinical concordances between Minicare cTnI and Architect hs-cTnI were 92% (admission) and 95% (2-4h), with lower concordances between Minicare cTnI and I-Stat cTnI (83% and 78%, respectively; p=0.007).
  
  
  CONCLUSIONS
  The Minicare cTnI POC assay may become useful for prompt and safe ruling-out of AMI in ED patients with suspected AMI using a guideline supported 0/3h sampling protocol.
authors.affiliation: Department of Medical Sciences, University of Uppsala, Uppsala, Sweden. Electronic address: per.venge@medsci.uu.se.
authors.forename: Per
authors.initials: P
authors.lastname: Venge
authors.affiliation: Philips Handheld Diagnostics, Eindhoven, The Netherlands.
authors.forename: Lian
authors.initials: L
authors.lastname: van Lippen
authors.affiliation: Interdisciplinary Emergency Care Unit, University Medical Center Göttingen, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Blaschke
authors.affiliation: Emergency Department, Luzerner Kantonsspital, Luzern, Switzerland; Department of Emergency and Critical Care Medicine, Paracelsus Medical University, Nuernberg General Hospital, Nuernberg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Christ
authors.affiliation: Department of Emergency and Critical Care Medicine, Paracelsus Medical University, Nuernberg General Hospital, Nuernberg, Germany.
authors.forename: Felicitas
authors.initials: F
authors.lastname: Geier
authors.affiliation: Medizinische Klinik III, University of Heidelberg, Germany.
authors.forename: Evangelos
authors.initials: E
authors.lastname: Giannitsis
authors.affiliation: Uppsala Clinical Research Centre, Uppsala, Sweden.
authors.forename: Emil
authors.initials: E
authors.lastname: Hagström
authors.affiliation: Emergency Department, Hôpital Pitié-Salpêtrière, AP-HP and Sorbonne Universités UPMC Univ-Paris 06, GRC-14 BIOSFAST, Paris, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Hausfater
authors.affiliation: Emergency Department, Hôpital Henri Mondor, Créteil, France.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Khellaf
authors.affiliation: Department of Internal Medicine III - Cardiology and Angiology, Innsbruck Medical University, Innsbruck, Austria.
authors.forename: Johannes
authors.initials: J
authors.lastname: Mair
authors.affiliation: Emergency Department, Hôpital Pitié-Salpêtrière, AP-HP, Paris, France.
authors.forename: David
authors.initials: D
authors.lastname: Pariente
authors.affiliation: Clinical Laboratory, Catharina Ziekenhuis Eindhoven and Technical University Eindhoven, Eindhoven, The Netherlands.
authors.forename: Volkher
authors.initials: V
authors.lastname: Scharnhorst
authors.affiliation: Philips Handheld Diagnostics, Eindhoven, The Netherlands.
authors.forename: Veronique
authors.initials: V
authors.lastname: Semjonow
mesh_terms: D000368:Aged; D005260:Female; D006801:Humans; D057230:Limit of Detection; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000378:metabolism; D009206:Myocardium / Q000378:metabolism*; D019095:Point-of-Care Systems; D019210:Troponin I / Q000378:metabolism*
chemical_list: D019210:Troponin I
keywords: Acute myocardial infarction; Cardiac troponin I; Emergency medicine; Point-of-care