Evaluation of the performance of the OneTouch Select^® Plus blood glucose test system against ISO 15197:2013

Abstract

Objectives: Assess laboratory and in-clinic performance of the OneTouch Select^® Plus test system against ISO 15197:2013 standard for measurement of blood glucose. Methods: System performance assessed in laboratory against key patient, environmental and pharmacologic factors. User performance was assessed in clinic by system-naïve lay-users. Healthcare professionals assessed system accuracy on diabetes subjects in clinic. Results: The system demonstrated high levels of performance, meeting ISO 15197:2013 requirements in laboratory testing (precision, linearity, hematocrit, temperature, humidity and altitude). System performance was tested against 28 interferents, with an adverse interfering effect only being recorded for pralidoxime iodide. Clinic user performance results fulfilled ISO 15197:2013 accuracy criteria. Subjects agreed that the color range indicator clearly showed if they were low, in-range or high and helped them better understand glucose results. Conclusion: The system evaluated is accurate and meets all ISO 15197:2013 requirements as per the tests described. The color range indicator helped subjects understand glucose results and supports patients in following healthcare professional recommendations on glucose targets.

Keywords:

• blood glucose measurement
• color range indicator
• ISO 15197:2013
• self-monitoring
• test strip

Key Issues

• Study was designed to assess the laboratory and in-clinic performance of the OneTouch Select^® Plus test system against the ISO 15197:2013 standard for measurement of blood glucose.

• The system demonstrated high levels of performance, meeting ISO 15197:2013 requirements in laboratory testing for precision, linearity, hematocrit (30–55%), temperature (10–44°C), humidity (10–90 %RH) and altitude (0–3048 m).

• System performance was not adversely affected when tested against 27 interferents, with an adverse interfering effect only being recorded for PAM.

• User performance results from system-naïve subjects (98.2%, 162/165) and system accuracy results, administered on diabetes patients by HCPs (100%, 165/165), fulfilled ISO 15197:2013 accuracy criteria.

• At glucose levels <5.55 mmol/L (100 mg/dL), 100% (36/36) and 91.7% (33/36) of lay-user data were within ±0.83 mmol/L (±15 mg/dL) and ±0.56 mmol/L (±10 mg/dL) of reference values, respectively.

• Subjects agreed that the CRI clearly showed if they were low, in-range or high (99%) and helped them better understand glucose results (92%).

Financial & competing interests disclosure

The authors were supported by LifeScan Scotland LTD Inverness, UK. S. Setford, A. Smith, D. McColl, M. Grady, K. Koria and H. Cameron are employees of LifeScan Scotland LTD. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Stuart Phillips, LifeScan Scotland LTD, assisted in the preparation of Table 1.