Korean J Lab Med.  2009 Oct;29(5):423-429. 10.3343/kjlm.2009.29.5.423.

Analytical Performance Evaluation of Glucose Monitoring System Following ISO15197

• An D
• Chung HJ
• Lee HW
• Lee W
• Chun S
• Min WK

• KMID: 1077418
• DOI: http://doi.org/10.3343/kjlm.2009.29.5.423

Abstract

BACKGROUND
We have evaluated the analytical performance of SureStep Flexx (Johnson and Johnson, USA) which can report the plasma equivalent glucose test results and be connected to the hospital information networks, following ISO15197 analytic procedure for glucometer for the first time.
METHODS
Adopting the guidelines of ISO15197, we measured the precision of ten glucometers from their repeatability and intermediate precision, and determined the accuracies of the glucometer, comparing to those of GEM Premier 4000 (Instrumentation Laboratory, USA). In addition, the guidelines of CLSI EP9-A2 and EP6-A were applied to correlate between data of glucometer and those of laboratory reference method by TBA-200FR (Toshiba Medical Systems, Japan) and to examine its linearity of glucose concentrations measured by SureStep Flexx. We used the clinical specimens and commercial control materials.
RESULTS
Repeatabilities and intermediate precisions of those glucometers were 4.0-7.3%, and 4.3-6.2%, respectively. When glucose levels are under 75 mg/dL, the difference between results of those meters and the reference values were within +/-6 mg/dL. However when glucose levels are over 75 mg/dL, those differences were within +/-12.7%. These results were acceptable for the ISO15197 criteria in all glucose concentrations. The glucose concentrations showed the clinically relevant linearity in the range from 36 mg/dL to 491 mg/dL. Moreover, Error Grid Analysis showed that all glucose results were in "zone A", which means that these values were clinically accurate.
CONCLUSIONS
This study showed that SureStep Flexx can provide reliable results for patients and clinicians to manage the diabetes mellitus, satisfying the ISO15197 criteria.

Keyword

SureStep Flexx; Networked glucometer; ISO15197; Evaluation; POCT

MeSH Terms

Blood Glucose/*analysis
Blood Glucose Self-Monitoring/*instrumentation/methods/*standards
Diabetes Mellitus/blood/diagnosis
Humans
Quality Control
Reference Values
Reproducibility of Results

Figure

• 

  Fig. 1. Accuracy of the SureStep Flexx compared with GEM Premier 4000 (A) Error Grid Analysis showed that all glucose measurements by SureStep Flexx were included in zone A. Dotted line represents regression analysis. Zone A represents no effect on clinical action; zone B represents altered clinical action-little or no effect on clinical outcome; zone C represents altered clinical action-likely to affect clinical outcome; zone D represents altered clinical action-could have significant medical risk; and zone E represents altered clinical action-could have dangerous consequences [5]. (B) Modified Bland-Altman plots with superimposed ISO15197 tolerance band.

• 

  Fig. 2. Correlation of glucose concentrations measured by SureStep Flexx versus TBA-200FR (A) Error Grid Analysis of the SureStep Flexx glucose measurements compared with TBA-200FR. All glucose results by the SureStep Flexx were included in zone A (See Fig. 1.). Dotted line represents regression analysis. (B) Modified Bland-Altman plots with superimposed ISO15197 tolerance band.

• 

  Fig. 3. Analytical measuring range of the SureStep Flexx was 36-491 mg/dL. The straight line was determined by a linear regression of the measured glucose concentrations with those of the expected glucose concentrations.

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