title: Clinical evaluation of the FreeStyle Precision Pro system.
abstract: BACKGROUND
  A new version of international standard (ISO 15197) and CLSI Guideline (POCT12) with more stringent accuracy criteria are near publication. We evaluated the glucose test performance of the FreeStyle Precision Pro system, a new blood glucose monitoring system (BGMS) designed to enhance accuracy for point-of-care testing (POCT).
  
  
  METHODS
  Precision, interference and system accuracy with 503 blood samples from capillary, venous and arterial sources were evaluated in a multicenter study. Study results were analyzed and presented in accordance with the specifications and recommendations of the final draft ISO 15197 and the new POCT12.
  
  
  RESULTS
  The FreeStyle Precision Pro system demonstrated acceptable precision (CV <5%), no interference across a hematocrit range of 15-65%, and, except for xylose, no interference from 24 of 25 potentially interfering substances. It also met all accuracy criteria specified in the final draft ISO 15197 and POCT12, with 97.3-98.9% of the individual results of various blood sample types agreeing within ±12 mg/dl of the laboratory analyzer values at glucose concentrations <100mg/dl and within ±12.5% of the laboratory analyzer values at glucose concentrations ≥100 mg/dl.
  
  
  CONCLUSIONS
  The FreeStyle Precision Pro system met the tighter accuracy requirements, providing a means for enhancing accuracy for point-of-care blood glucose monitoring.
authors.affiliation: Rainier Clinical Research Center, Renton, WA, United States.
authors.forename: Ronald
authors.initials: R
authors.lastname: Brazg
authors.forename: Kristen
authors.initials: K
authors.lastname: Hughes
authors.forename: Pamela
authors.initials: P
authors.lastname: Martin
authors.forename: Julie
authors.initials: J
authors.lastname: Coard
authors.forename: John
authors.initials: J
authors.lastname: Toffaletti
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McDonnell
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Taylor
authors.forename: Lausanne
authors.initials: L
authors.lastname: Farrell
authors.forename: Mona
authors.initials: M
authors.lastname: Patel
authors.forename: Jeanne
authors.initials: J
authors.lastname: Ward
authors.forename: Ting
authors.initials: T
authors.lastname: Chen
authors.forename: Shridhara
authors.initials: S
authors.lastname: Alva
authors.forename: Ronald
authors.initials: R
authors.lastname: Ng
mesh_terms: D057205:Automation, Laboratory / Q000295:instrumentation / Q000592:standards*; D001786:Blood Glucose / Q000032:analysis*; D006400:Hematocrit / Q000706:statistics & numerical data; D006801:Humans; D007362:Intensive Care Units; D019095:Point-of-Care Systems; D017410:Practice Guidelines as Topic; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D001786:Blood Glucose