Clinical impact of improved point-of-care glucose monitoring in neonatal intensive care using Nova StatStrip: Evidence for improved accuracy, better sensitivity, and reduced test utilization.

OBJECTIVES: Studies have demonstrated improved analytical performance of the Nova StatStrip glucose meter, but limited data is available on its clinical performance in critically ill neonates in the neonatal intensive care unit (NICU). DESIGN AND METHODS: A retrospective charge review was conducted on 651 neonates admitted to the NICU over 2 years. Demographics, sample collection information, and clinical details were recorded. Glucose measurements were performed at the bedside using either the Nova StraStrip or LifeScan SureStep Flexx meters as well as corresponding measurements of laboratory venous plasma glucose. Performance was analyzed by receiver operator characteristic (ROC) curves for detecting hypoglycemia and critical glucose levels. RESULTS: Linear regression analysis comparing StatStrip and laboratory venous plasma glucose samples demonstrated significantly tighter agreement (r(2)=0.7994) and accuracy (mean bias=0.13mmol/L) than SureStep (r(2)=0.6845 and mean bias=0.53mmol/L). StatStrip also showed improved sensitivity for detecting critical low glucose values ≤3.0mmol/L (80.9 vs 68.9%, p<0.05). ROC curve analysis further demonstrated excellent performance of StatStrip at this cutoff with an AUC of 0.98. Overall, neonates were also tested significantly less frequently with the StatStrip meter by 24% compared to SureStep. CONCLUSIONS: Implementation of StatStrip led to better agreement with venous plasma glucose, improved detection of critical low glucose results, and more efficient test utilization. This study demonstrates the importance of accurate and sensitive glucose monitoring in the NICU.

Advances in Pediatric Reference Intervals for Biochemical Markers: Establishment of the Caliper Database in Healthy Children and Adolescents.

Clinical laboratory reference intervals provide valuable information to medical practitioners in their interpretation of quantitative laboratory test results, and therefore are critical in the assessment of patient health and in clinical decision-making. The reference interval serves as a health-associated benchmark with which to compare an individual test result. Unfortunately, critical gaps currently exist in accurate and up-to-date pediatric reference intervals for accurate interpretation of laboratory tests performed in children and adolescents. These critical gaps in the available laboratory reference intervals have the clear potential of contributing to erroneous diagnosis or misdiagnosis of many diseases. To address these important gaps, several initiatives have begun internationally by a number of bodies including the KiGGS initiative in Germany, the Aussie Normals in Australia, the AACC-National Children Study in USA, the NORICHILD Initiative in Scandinavia, and the CALIPER study in Canada. In the present article, we will review the gaps in pediatric reference intervals, challenges in establishing pediatric norms in healthy children and adolescents, and the major contributions of the CALIPER program to closing the gaps in this crucial area of pediatric laboratory medicine. We will also discuss the recently published CALIPER reference interval database (www.caliperdatabase.com) developed to provide comprehensive age and gender specific pediatric reference intervals for a larger number of biochemical markers, based on a large and diverse healthy children cohort. The CALIPER database is based on a multiethnic population examining the influence of ethnicity on laboratory reference intervals. Thus the database has proved to be of global benefit and is being adopted by hospital laboratories worldwide.