. J.B. is employed by Bayer Corporation and M.L., N.C.B., T.C.N., and J.O.J. were clinical investigators for the present study.Abbreviations: PCOT, point-of-care testing. A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances. Multicenter Evaluation of the Glucometer Elite XL Meter, an Instrument Specifically Designed for Use With Neonates O R I G I N A L A R T I C L EOBJECTIVE -To evaluate the clinical performance of the Glucometer Elite XL Diabetes Care System in neonatal settings using a multicenter study. RESEARCH DESIGN AND METHODS -A total of 388 blood specimens from 333neonates were included in the study. A capillary or arterial sample was analyzed for determination of glucose with the Glucometer Elite XL system by an attending trained nurse. Through the same sampling site, a specimen was collected and sent to the laboratory for measurement of plasma glucose, bilirubin, and hematocrit.RESULTS -The regression analysis between the results of the Glucometer Elite XL system and comparative methods resulted in the following: Glucometer Elite XL meter = 1.01 ϫ laboratory method ϩ 0.02 mmol/l (n = 388). For the 1.1-4.0 mmol/l plasma glucose range, the regression was Glucometer Elite XL meter = 1.07 ϫ laboratory method ϩ 0.12 mmol/l (n = 150). A difference plot indicated a mean bias of 0.04 mmol/l (95% CI Ϫ0.01 to 0.10). No relationship was found between meter glucose biases and hematocrit levels (r = 0.10, P = 0.14). Although a statistically significant correlation existed between bilirubin levels and the glucose meter biases (r = 0.14, P = 0.005), the predicted mean biases were of little clinical significance.CONCLUSIONS -The Glucometer Elite XL system showed a good performance when used in neonatal settings. E m e r g i n g T r e a t m e n t s a n d T e c h n o l o g i e s Diabetes 1150DIABETES CARE, VOLUME 23, NUMBER 8, AUGUST 2000Blood glucose meter for neonates ethics committee at each site approved the study. Collaborators assigned to the project (mostly nurses and laboratory technologists) were trained before the beginning of the study. They were taught to use the Glucometer Elite XL system, and each of them performed triplicate assays of the glucose control solutions (low, normal, and high) to familiarize themselves with the meter, reagents, and proper testing technique. Meter operators performed glucose measurements using control solutions (in duplicate) each day that they performed a plasma glucose measurement on a neonate. Also, electronic components of the meter were tested each day using the Check Strip (Bayer). One lot of test strips was used for the entire study.The laboratory comparative methods were assessed for precision and accuracy. Six levels of serum glucose control samples with glucose concentrations determined using the Centers for Disease Control and Prevention/National Institute for Standards and Technology hexokinase reference method for glucose (9) were analyzed (in duplicate) before the study and once each we...

When certain meter code number settings of two BGMSs were used in conjunction with test strips having code numbers that did not match, statistically and clinically inaccurate results were obtained. Coding errors resulted in analytical errors of greater than +/-30% (-31.6 to +60.9%). These results confirm the value of a BGMS with an automatic coding feature.

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