Clinical performance of the new glucometer in the nursery and neonatal intensive care unit

Abstract

Background: Performance of point-of-care (POC) glucometers in newborns have been unsatisfactory in low glucose concentration range and the effects of different hematocrit levels on glucose measurements have also demonstrated in currently used POC glucometers. Methods: The aim of this study was to evaluate the performance of the new glucometer (Nova-Statstrip®; Nova Biomedical, Waltham, MA, USA) compared to the reference method. Venous blood specimens of neonates were collected and tested by the two glucometers. Standard reference was performed using the hexokinase method within 10 min of blood collection. Hematocrit and total serum bilirubin measurements were performed simultaneously. Results: One hundred and fifty-one blood specimens were collected and measured by the reference method with plasma glucose concentrations ranging from 12 to 371 mg/dL. Twenty-one specimens had plasma glucose concentrations < 45 mg/dL. At plasma glucose concentrations less than 75 mg/dL, the Statstrip® achieved 93% in the tests for discrepancy < 15 mg/dL. At a glucose concentration more than 75 mg/dL, 97% of the Statstrip® readings were within 20% of the reference values. The mean difference (A±2SD) of the Statstrip® was 2.8 (-14.1, 19.7) mg/dL. At a hypoglycemic level ( < 45 mg/dL), it showed a sensitivity of 95.2%. No significant interference of hematocrit or total serum bilirubin was found on the mean bias of the Statstrip®. Conclusion: The new glucometer (Nova-Statstrip®) could be used for point-of-care blood glucose measurement in neonates as it showed a narrow margin of error and had no hematocrit or bilirubin interference. © 2011 The Authors.