Evaluation and Performance of StatStrip Glucose Meter

Abstract

Point-of-care testing glucose meter use is on the increase and is widely used in monitoring hospitalized patients as well as by patients for self-monitoring. A major concern is the accuracy of glucose meters in different clinical settings. StatStrip (Nova Biomedical, Waltham, Mass) is a new generation glucose and quantitative ketone meter designed to correct for common biochemical interferences and to measure and correct hematocrit. Our aim was to assess the analytical performance of the StatStrip (Xpress and Connectivity) to Accu-Chek Active meters (Roche Diagnostics, Mannheim, Germany) and assess the glucose meters in a clinical setting. Hematocrit interference and chemical interferences (ascorbic acid, maltose, xylose, and acetaminophen) were evaluated at different glucose levels and different interferent concentrations. Whole blood samples collected from patients attending the medical outpatients department were measured and compared with the reference method (Siemens Advia glucose oxidase) and assessed by comparison with the ISO 15197 glucose performance criteria. Diabetic patients were included for this evaluation. Finger-prick (capillary) glucose (obtained from diabetic patients) measured on the glucose meters was compared with plasma glucose measured in the laboratory (Siemens Advia glucose oxidase). Minimal hematocrit and chemical interference were observed on the StatStrip meters, whereas the Accu-Chek Active meters were significantly affected by both abnormal hematocrit and chemical interference. StatStrip correlated best to the reference method and demonstrated the lowest bias. The StatStrip glucose meters demonstrated acceptable correlation when compared with the reference method, were not susceptible to common interferences observed on currently used glucose meters, and performed well in the clinical setting.