title: Analytical evaluation of a new point of care system for measuring cardiac Troponin I.
abstract: OBJECTIVE
  Point-of-care cardiac troponin testing with adequate analytical performances has the potential to improve chest pain patients flow in the emergency department. We present the analytical evaluation of the newly developed Philips Minicare cTnI point-of-care immunoassay.
  
  
  METHODS
  Li-heparin whole blood and plasma were used to perform analytical studies. The sample type comparison study was performed at 4 different hospitals. The 99th percentile upper reference limit (URL) study was performed using Li-heparin plasma, Li-heparin whole blood and capillary blood samples from 750 healthy adults, aging from 18 to 86years.
  
  
  RESULTS
  Limit of the blank, limit of detection and limit of quantitation at 20% coefficient of variation (CV) were determined to be 8.5ng/L, 18ng/L and 38ng/L respectively without significant differences between whole blood and plasma for LoQ. Cross-reactivity and interferences were minimal and no high-dose hook was observed. Total CV was found to be from 7.3% to 12% for cTnI concentrations between 109.6 and 6135.4ng/L. CV at the 99th percentile URL was 18.6%. The sample type comparison study between capillary blood, Li-heparin whole blood and Li-heparin plasma samples demonstrated correlation coefficients between 0.99 and 1.00 with slopes between 1.03 and 1.08. The method comparison between Minicare cTnI and Beckman Coulter Access, AccuTnI+3 demonstrated a correlation coefficient of 0.973 with a slope of 1.09. The 99th percentile URL of a healthy population was calculated to be 43ng/L with no significant difference between genders or sample types.
  
  
  CONCLUSIONS
  The Minicare cTnI assay is a sensitive and precise, clinical usable test for determination of cTnI concentration that can be used in a near-patient setting as an aid in the diagnosis of acute myocardial infarction.
authors.affiliation: Philips Handheld Diagnostics, Eindhoven, The Netherlands. Electronic address: Danielle.Kemper@philips.com.
authors.forename: Danielle Wm
authors.initials: DW
authors.lastname: Kemper
authors.affiliation: Philips Handheld Diagnostics, Eindhoven, The Netherlands.
authors.forename: Veronique
authors.initials: V
authors.lastname: Semjonow
authors.affiliation: Philips Handheld Diagnostics, Eindhoven, The Netherlands.
authors.forename: Femke
authors.initials: F
authors.lastname: de Theije
authors.affiliation: Philips Handheld Diagnostics, Eindhoven, The Netherlands.
authors.forename: Diederick
authors.initials: D
authors.lastname: Keizer
authors.affiliation: Philips Handheld Diagnostics, Eindhoven, The Netherlands.
authors.forename: Lian
authors.initials: L
authors.lastname: van Lippen
authors.affiliation: Department of Internal Medicine III - Cardiology and Angiology, Medical University of Innsbruck, Innsbruck, Austria.
authors.forename: Johannes
authors.initials: J
authors.lastname: Mair
authors.affiliation: Department of Internal Medicine III - Cardiology and Angiology, Medical University of Innsbruck, Innsbruck, Austria.
authors.forename: Bernadette
authors.initials: B
authors.lastname: Wille
authors.affiliation: 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: Emergency Department, Hôpital Pitié-Salpêtrière, AP-HP et Sorbonne Universités UPMC Univ-Paris 06, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Hausfater
authors.affiliation: Emergency Department, Hôpital Pitié-Salpêtrière, AP-HP et Sorbonne Universités UPMC Univ-Paris 06, 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: Clinical laboratory, Catharina Ziekenhuis Eindhoven and Technical University Eindhoven, Eindhoven, The Netherlands.
authors.forename: Joyce
authors.initials: J
authors.lastname: Curvers
authors.affiliation: Philips Handheld Diagnostics, Eindhoven, The Netherlands.
authors.forename: Jeroen
authors.initials: J
authors.lastname: Nieuwenhuis
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D001774:Blood Chemical Analysis / Q000379:methods*; D005260:Female; D006801:Humans; D057230:Limit of Detection; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000097:blood / Q000175:diagnosis; D019095:Point-of-Care Systems; D012016:Reference Values; D019210:Troponin I / Q000097:blood*; D055815:Young Adult
chemical_list: D015415:Biomarkers; D019210:Troponin I
keywords: Acute myocardial infarction; Cardiac Troponin-I; Chest pain; Emergency medicine; Point-of-care