title: A comprehensive evaluation of the performance of the test strip technology for OneTouch Verio glucose meter systems.
abstract: BACKGROUND
  OneTouch® Verio™ test strips (LifeScan Inc., Milpitas, CA) are designed to minimize error when used in blood glucose monitoring systems. These strips have a specialized architecture and incorporate a sophisticated waveform and proprietary algorithm.
  
  
  METHODS
  Performance of OneTouch Verio test strips was assessed in the laboratory in the presence of a wide range of patient, environmental, and pharmacologic factors. A clinical evaluation was conducted in which 296 patients and healthcare professionals (HCPs) performed glucose testing using OneTouch Verio test strips and OneTouch VerioIQ meters.
  
  
  RESULTS
  In the laboratory study, OneTouch Verio test strip results achieved a high level of performance over a wide range of hematocrit (19-61%), temperature (5-45(°)C), humidity (10-90% relative humidity), and altitude (0-3,048 m) conditions. Performance was not affected by 22 of 23 chemical compounds. In the clinical study, 100% (31/31) of lay-user test results were within ±10 mg/dL of reference values for blood glucose <75 mg/dL. At blood glucose ≥75 mg/dL, 99.2% (243/245) were within ±15% of reference values. A feature of the VerioIQ meter, PatternAlert(™) Technology, was correctly used and positively evaluated by >98% of lay users.
  
  
  CONCLUSIONS
  OneTouch Verio test strips are accurate and precise over a wide range of patient, environmental, and pharmacologic conditions. In addition, lay-users were able to successfully use the OneTouch VerioIQ PatternAlert Technology without HCP training.
authors.affiliation: AMCR Institute, Inc., 700 West El Norte Parkway, Escondido, CA 92026, USA. tbailey@amcrinstitute.com
authors.forename: Timothy
authors.initials: T
authors.lastname: Bailey
authors.forename: Anna
authors.initials: A
authors.lastname: Chang
authors.forename: Paul D
authors.initials: PD
authors.lastname: Rosenblit
authors.forename: Loretta
authors.initials: L
authors.lastname: Jones
authors.forename: Gillian
authors.initials: G
authors.lastname: Teft
authors.forename: Steven
authors.initials: S
authors.lastname: Setford
authors.forename: John
authors.initials: J
authors.lastname: Mahoney
mesh_terms: D000465:Algorithms; D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000379:methods; D002140:California; D019411:Clinical Laboratory Techniques; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D005260:Female; D006400:Hematocrit; D006801:Humans; D008297:Male; D010594:Pharmacies; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D001786:Blood Glucose