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.

Materials and 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.