A comparison of statistical techniques to evaluate the performance of the Glucometer Elite blood glucose meter.
OBJECTIVE
The objective of the study was to measure the performance of the Glucometer Elite, a technique-independent device for self-monitoring of capillary blood glucose. Several potential sources of error were incorporated into the study, including variability between lots, the age of a lot, variability between subjects, and variability between strips.


METHODS
The Glucometer Elite was tested using capillary samples from 86 individuals. Duplicate readings with each of 8 sensor lots were done for each participant. Glucometer Elite readings were compared to YSI capillary plasma equivalent values, and the data was evaluated using a variety of both technical and clinical analysis methods.


RESULTS
All evaluation methods showed excellent agreement between the Glucometer Elite and the YSI plasma equivalent values.


CONCLUSIONS
The Glucometer Elite system provides accurate and clinically valuable information to the diabetic home tester.
Harrison
B
B
Bayer Corporation, Diagnostics Division, Elkhart, IN 46514, USA.
Markes
R
R
Bradley
P
P
Ismail
I A
IA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards; D003920:Diabetes Mellitus / Q000097:blood; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013223:Statistics as Topic / Q000379:methods
D001786:Blood Glucose