Evaluation of the Nova StatStrip glucometer in a pediatric hospital setting

Routine point-of-care (POC) glucose monitoring in the pediatric setting has become increasingly important, both for assessing hypoglycemia as well as hyperglycemia. A reliable and precise system is required to monitor pediatric patients. The aim of this study was to evaluate the Nova Biomedical Stat...

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Bibliographic Details
Published in:	Clinical biochemistry Vol. 47; no. 9; pp. 840 - 843
Main Authors:	Lockyer, M.G., Fu, K., Edwards, R.M., Collymore, L., Thomas, J., Hill, T., Devaraj, S.
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-06-2014
Subjects:	Blood Glucose Glucometer Glucose monitoring Hospitals, Pediatric Humans Hyperglycemia Hypoglycemia Hypoglycemia - blood Hypoglycemia - diagnosis Infant, Newborn Neonatal Screening Neonate Newborn Pediatrics Point-of-Care Systems Point-of-care testing Reagent Strips - standards Reference Standards Reproducibility of Results Sensitivity and Specificity Point-of-care testing Glucose monitoring Pediatrics Hyperglycemia Newborn Neonate Glucometer Hypoglycemia
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Summary:	Routine point-of-care (POC) glucose monitoring in the pediatric setting has become increasingly important, both for assessing hypoglycemia as well as hyperglycemia. A reliable and precise system is required to monitor pediatric patients. The aim of this study was to evaluate the Nova Biomedical StatStrip POC glucometer against the Roche ACCU-CHEK Inform in lieu of our currently used LifeScanSureStepFlexx POC glucose analyzer. Intra-assay and inter-assay precision, linearity, correlation and interference studies were performed as per the NCCLS criteria. An analysis of 37 pediatric samples across the linearity ranges of all the meters was used to assess concordance between the systems. The Nova StatStrip glucometer demonstrated an excellent coefficient of variation (<5%) for glucose across the entire analytical measurement range. The Nova StatStrip also had good concordance with the central laboratory (Bland–Altman plots r2=0.01), while Roche Inform had poorer correlation (Bland–Altman plots r2=0.46). We also evaluated the effect of hematocrit (20–60%) and maltose (100–500mg/dL) on the Nova StatStrip analyzer and demonstrated that there is little to no interference by either. The Nova StatStrip system gave the best performance with acceptable imprecision, good correlation, and minimal to no interference from hematocrit levels or maltose. The Nova StatStrip is a satisfactory replacement for our POC glucometer system and, additionally, provides results in less time (just 6 s) utilizing a lower amount of blood with the advantage of being immediately interfaced to our laboratory information systems. •Three point-of-care glucose monitoring systems are evaluated.•Inter-assay, intra-assay, linearity, concordance and interference studies are performed.•A reliable point-of-care glucose monitoring system is required for use in pediatric hospitals.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0009-9120 1873-2933
DOI:	10.1016/j.clinbiochem.2014.01.004