title: Evaluation of the GEM®PCL Plus point-of-care device for neonatal coagulation assessment: an observational study on cord blood.
abstract: BACKGROUND
  Point of care devices (POCT) are used for coagulation evaluation in adults. Reduced blood volumes and the direct use of whole blood allow studies when venous puncture is difficult, such as in newborns. Elimination of sample transport is attractive for use in emergencies and intensive care.
  
  
  OBJECTIVE
  To prospectively compare neonatal coagulation parameters measured by the GEM®PCL POCT versus a central laboratory.
  
  
  METHODS
  Prothrombin Time (PT) and activated Partial Thromboplastin Time (aPTT) were performed on whole cord blood (POCT) and plasma (central laboratory) collected from consecutive newborns at Geneva University Hospitals. Agreement was assessed with a Bland & Altman plot and intra-class correlation coefficient (ICC) in 213 newborns cord blood; intra-assay variability (repeatability) was assessed using ICC and coefficient of variation (CV).
  
  
  RESULTS
  189 samples were available for the agreement analysis, 24 were excluded for technical problems. The 95% limits of agreements in the Bland & Altman plot ranged from -5.6 to 11.6 and from -39.6 to 11.6seconds for the PT and aPTT, respectively. The ICC between the two methods was 0.28 (CI 95% 0.06 to 0.47) for PT and 0.20 (CI 95% -0.06 to 0.42) for aPTT. Repeatability (ICC) on the 43 eligible samples was 0.46 (CI 95% 0.19 to 0.67) for PT and 0.52 (CI 95% 0.26 to 0.71) for aPTT. The CV was 10.6% and 12% for PT and aPTT, respectively.
  
  
  CONCLUSIONS
  In newborn cord blood, PT and aPTT measurements with the GEM®PCL POCT had poor agreement with the central laboratory and poor repeatability.
authors.affiliation: Neonatology and Paediatric Intensive Care Unit, Paediatrics Department, Faculty of Medicine of Geneva & University Hospitals of Geneva, 4, Rue Gabrielle-Perret-Gentil, CH-1211 Geneva 14, Switzerland.
authors.forename: Roberta
authors.initials: R
authors.lastname: De Luca
authors.affiliation: Division of Angiology and Haemostasis, Faculty of Medicine of Geneva & University Hospitals of Geneva, 4, Rue Gabrielle-Perret-Gentil, CH-1211 Geneva 14, Switzerland.
authors.forename: Pierre
authors.initials: P
authors.lastname: Fontana
authors.affiliation: CRC & Division of Clinical Epidemiology, Department of health and community Medicine, Faculty of Medicine of Geneva & University Hospitals of Geneva, 4, Rue Gabrielle-Perret-Gentil, CH-1211 Geneva 14, Switzerland.
authors.forename: Antoine
authors.initials: A
authors.lastname: Poncet
authors.affiliation: Division of Angiology and Haemostasis, Faculty of Medicine of Geneva & University Hospitals of Geneva, 4, Rue Gabrielle-Perret-Gentil, CH-1211 Geneva 14, Switzerland. Electronic address: philippe.demoerloose@hcuge.ch.
authors.forename: Philippe
authors.initials: P
authors.lastname: de Moerloose
authors.affiliation: Neonatology and Paediatric Intensive Care Unit, Paediatrics Department, Faculty of Medicine of Geneva & University Hospitals of Geneva, 4, Rue Gabrielle-Perret-Gentil, CH-1211 Geneva 14, Switzerland.
authors.forename: Riccardo E
authors.initials: RE
authors.lastname: Pfister
mesh_terms: D001777:Blood Coagulation; D005260:Female; D005312:Fetal Blood / Q000502:physiology*; D006801:Humans; D007231:Infant, Newborn / Q000097:blood*; D008297:Male; D010314:Partial Thromboplastin Time / Q000295:instrumentation*; D019095:Point-of-Care Systems; D011517:Prothrombin Time / Q000295:instrumentation*; D015203:Reproducibility of Results
keywords: Coagulation; Hemostasis; Newborn; Point-of-Care Systems; Umbilical cord blood