title: Point-of-care PT and aPTT in patients with suspected deficiencies of coagulation factors.
abstract: BACKGROUND
  There are several clinical settings and patient conditions especially in intensive care units, emergency departments, and operating theaters, where the coagulation status of a patient must be known immediately and point-of-care (POC) systems are beneficial due to low time to result.
  
  
  METHODS
  This noninterventional, single-blinded, multicenter study with prospectively collected whole blood samples was performed to evaluate the diagnostic accuracy of the CoaguChek PT Test (POC PT) and CoaguChek aPTT Test (POC aPTT) compared to standard laboratory testing in patients with suspected deficiencies of coagulation factors.
  
  
  RESULTS
  In total, 390 subjects were included. Both POC PT and POC aPTT showed concordance with the laboratory PT and aPTT. Lot-to-lot variation was below 2% both for POC PT and for POC aPTT. The mean relative difference of capillary blood compared to venous blood was 0.2 % with POC PT and 8.4% with POC aPTT. The coefficients of variation for repeatability of POC PT using whole blood were found to be between 2% and 3.6%.
  
  
  CONCLUSIONS
  Our findings suggest reliable quantitative results with this POC system to support on-site decision-making for patients with suspected deficiencies of coagulation factors in acute and intensive care.
authors.affiliation: Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.
authors.forename: J
authors.initials: J
authors.lastname: Niederdöckl
authors.affiliation: Coagulation Center Mannheim, Mannheim, Germany.
authors.forename: C-E
authors.initials: CE
authors.lastname: Dempfle
authors.affiliation: Internal Medicine, Hospital St. Vinzenz Zams, Zams, Austria.
authors.forename: H-R
authors.initials: HR
authors.lastname: Schönherr
authors.affiliation: Roche Diagnostics GmbH, Mannheim, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Bartsch
authors.affiliation: Roche Diagnostics Corporation, Indianapolis, IN, USA.
authors.forename: G
authors.initials: G
authors.lastname: Miles
authors.affiliation: Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.
authors.forename: A
authors.initials: A
authors.lastname: Laggner
authors.affiliation: Gastroenterology, Intermediate and Intensive Care Unit, University Clinic Heidelberg, Heidelberg, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Pathil
mesh_terms: D001779:Blood Coagulation Factors / Q000032:analysis; D019411:Clinical Laboratory Techniques / Q000592:standards; D020147:Coagulation Protein Disorders / Q000175:diagnosis*; D006801:Humans; D010314:Partial Thromboplastin Time / Q000379:methods / Q000592:standards*; D019095:Point-of-Care Systems / Q000592:standards*; D011446:Prospective Studies; D011517:Prothrombin Time / Q000379:methods / Q000592:standards*; D015203:Reproducibility of Results; D016037:Single-Blind Method
chemical_list: D001779:Blood Coagulation Factors
keywords: PT; aPTT; coagulation factor deficiency; hospital; point-of-care testing