Accuracy of the One Touch II whole blood glucose analyzer when used by analysts with diverse technical backgrounds.
BACKGROUND
The accuracy of hand-held analytical systems is dependent on the complexity of the instrument and the technical skills of the tester. We evaluated the analytical performance of the LifeScan One Touch II glucose analyzer when used by persons with various levels of technical skill and experience.


METHODS
A medical technologist conducted tests on three One Touch II systems to ensure that the units were functioning properly. The technologist then trained six analysts (a physician, a registered nurse, a licensed practical nurse, a physician assistant, and two patients) in the proper use of the glucose analyzer.


RESULTS
In the hands of a medical technologist, the precision of the three glucose analyzers tested was from 1.0% to 1.9% coefficient of variation (CV) and from 2.3% to 4.2% CV for the low- and high-quality control materials, respectively. The day-to-day precision (5-day period) was from 2.1% to 3.6% CV, and from 3.5% to 4.1% CV for the low- and high-quality control materials, respectively. Comparisons of the glucose values (n = 40 fresh patient serum samples) with a reference method yielded a correlation coefficient of 0.992 to 0.993, and an overall bias of -7%. Although the values obtained by the six operators were statistically different, the differences were not clinically relevant.


CONCLUSIONS
Our data suggest that the One Touch II glucose analyzer is a reliable system, and that its function is not dependent on the technical skills of the operator.
Naito
H K
HK
Veterans Affairs National Center for Laboratory Accuracy and Standardization, Cleveland, OH.
Kwak
Y S
YS
Cottingham
C
C
D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000592:standards; D004867:Equipment Design / Q000592:standards; D006282:Health Personnel / Q000592:standards; D006801:Humans; D017056:Medical Laboratory Personnel / Q000592:standards; D015203:Reproducibility of Results
D001786:Blood Glucose