title: Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods - a prospective multinational trial.
abstract: BACKGROUND
  Procalcitonin (PCT) is increasingly being used for the diagnostic and prognostic work up of patients with suspected infections in the emergency department (ED). Recently, B·R·A·H·M·S PCT direct, the first high sensitive point-of-care test (POCT), has been developed for fast PCT measurement on capillary or venous blood samples.
  
  
  METHODS
  This is a prospective, international comparison study conducted in three European EDs. Consecutive patients with suspicion of bacterial infection were included. Duplicate determination of PCT was performed in capillary (fingertip) and venous whole blood (EDTA), and compared to the reference method. The diagnostic accuracy was evaluated by correlation and concordance analyses.
  
  
  RESULTS
  Three hundred and three patients were included over a 6-month period (60.4% male, median age 65.2 years). The correlation between capillary or venous whole blood and the reference method was excellent: r2=0.96 and 0.97, sensitivity 88.1% and 93.0%, specificity 96.5% and 96.8%, concordance 93% and 95%, respectively at a 0.25 μg/L threshold. No significant bias was observed (-0.04 and -0.02 for capillary and venous whole blood) although there were 6.8% and 5.1% outliers, respectively. B·R·A·H·M·S PCT direct had a shorter time to result as compared to the reference method (25 vs. 144 min, difference 119 min, 95% CI 110-134 min, p<0.0001).
  
  
  CONCLUSIONS
  This study found a high diagnostic accuracy and a faster time to result of B·R·A·H·M·S PCT direct in the ED setting, allowing shortening time to therapy and a more wide-spread use of PCT.
authors.forename: Alexander
authors.initials: A
authors.lastname: Kutz
authors.forename: Pierre
authors.initials: P
authors.lastname: Hausfater
authors.forename: Michael
authors.initials: M
authors.lastname: Oppert
authors.forename: Murat
authors.initials: M
authors.lastname: Alan
authors.forename: Eva
authors.initials: E
authors.lastname: Grolimund
authors.forename: Claire
authors.initials: C
authors.lastname: Gast
authors.forename: Christine
authors.initials: C
authors.lastname: Alonso
authors.forename: Christoph
authors.initials: C
authors.lastname: Wissmann
authors.forename: Christian
authors.initials: C
authors.lastname: Kuehn
authors.forename: Maguy
authors.initials: M
authors.lastname: Bernard
authors.forename: Andreas
authors.initials: A
authors.lastname: Huber
authors.forename: Beat
authors.initials: B
authors.lastname: Mueller
authors.forename: Philipp
authors.initials: P
authors.lastname: Schuetz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001774:Blood Chemical Analysis / Q000379:methods* / Q000592:standards; D002116:Calcitonin / Q000097:blood*; D015740:Calcitonin Gene-Related Peptide; D002846:Chromatography, Affinity / Q000379:methods*; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000067716:Point-of-Care Testing / Q000592:standards; D011446:Prospective Studies; D011498:Protein Precursors / Q000097:blood*; D055815:Young Adult
chemical_list: C000606589:CALCA protein, human; D011498:Protein Precursors; D002116:Calcitonin; D015740:Calcitonin Gene-Related Peptide