[Analytical performance evaluation of glucose monitoring system following ISO15197].
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.
An
Dongheui
D
Department of Laboratory Medicine, University of Ulsan College of Medicine, Seoul, Korea.
Chung
Hee Jung
HJ
Lee
Hye Won
HW
Lee
Woochang
W
Chun
Sail
S
Min
Won Ki
WK
D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000379:methods / Q000592:standards*; D003920:Diabetes Mellitus / Q000097:blood / Q000175:diagnosis; D006801:Humans; D011786:Quality Control; D012016:Reference Values; D015203:Reproducibility of Results
D001786:Blood Glucose