Abstract
Hypoglycemia in infants is common, is difficult to recognize, and may lead to permanent neurologic impairment. Low glucose concentrations and high hematocrits in newborns pose significant analytic challenges for whole blood glucose meters. Three Bayer glucose monitoring systems were evaluated using 211 blood samples from 162 neonates (age range 5 hours to 29 days, median age 3 days). Hematocrit and whole blood glucose were determined in heparinized whole blood, and plasma glucose was determined using the Roche Cobas 6000. Accuracy was evaluated against plasma concentrations using ISO 15197:2013 and CLSI POCT 12-A3 criteria. Glucose imprecision on the Cobas system was 1.8-2.6% (CV) from 26-610 mg/dL. Imprecision across all meter systems was 2.8% (CV) at 130 mg/dL. Glucose concentrations, hematocrit, and total bilirubin ranged from 20-150 mg/dL, 18 -75%, and 0.5-19.6 mg/dL, respectively. Linear regression analysis of whole blood versus plasma for the 3 combined systems yielded an average slope of 1.06 and correlation coefficient greater than 0.980. Bias between the Contour and Cobas was not significantly correlated with hematocrit. Greater than 99% of meter results were within 15 mg/dL and 20% of plasma results at glucose concentrations ≤ 75 and > 75 mg/dL, respectively. Of meter results, 97% were within 12.5 mg/dL of plasma results at concentrations ≤ 100 mg/dL, while 96% of meter results were within 12.5% of plasma at concentrations > 100 mg/dL. The Bayer CONTOUR Blood Glucose Monitoring Systems exceed ISO 15197:2013 and CLSI criteria in neonatal blood samples.