M G Lockyer1, K Fu1, R M Edwards2, L Collymore2, J Thomas2, T Hill2, S Devaraj3. 1. Baylor College of Medicine, 1 Baylor Plaza MC 315, Houston, TX, 77030, USA. 2. Texas Children's Hospital, Houston, TX, 77030, USA. 3. Baylor College of Medicine, 1 Baylor Plaza MC 315, Houston, TX, 77030, USA; Texas Children's Hospital, Houston, TX, 77030, USA. Electronic address: sxdevara@texaschildrens.org.
Abstract
CONTEXT: 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. OBJECTIVES: 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. DESIGN AND METHODS: 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. RESULTS: 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 r(2)=0.01), while Roche Inform had poorer correlation (Bland-Altman plots r(2)=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. CONCLUSIONS: 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.
CONTEXT: 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. OBJECTIVES: 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. DESIGN AND METHODS: 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. RESULTS: 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 r(2)=0.01), while Roche Inform had poorer correlation (Bland-Altman plots r(2)=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. CONCLUSIONS: 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.
Authors: Catherine E Majors; Chelsey A Smith; Mary E Natoli; Kathryn A Kundrod; Rebecca Richards-Kortum Journal: Lab Chip Date: 2017-10-11 Impact factor: 6.799