[Validation of a glucose meter at an intensive care unit]

Abstract

Introduction: Hyperglycemic patients admitted to Intensive care units (ICUs) have higher morbidity and mortality than normoglycemic patients. Blood glucose levels of ICU patients are usually measured with a glucose meter. The aim of this study was to evaluate a glucose meter (StatStrip, Nova Biomedical) to assess its agreement with the standard laboratory method for testing glucose.

Material and methods: Eighty-nine different samples were collected from patients (76.4% men and 23.6% women) admitted to an ICU from September to December 2010. Each blood sample was collected into two tubes, a lithium heparin tube and an EDTA tube. The total blood aliquot was used to measure glycemia using the glucose meter. The lithium heparin tube was processed at the same time for measuring plasma glucose (Cobas 6000 Analyzer, Roche Diagnostics, SA). Agreement between the two methods was assessed according to the EP-9-A2 Clinical Laboratory Standards Institute guideline.

Results: Mean whole blood glucose level measured by the glucose meter was 126.53+49.28 mg/dL (range, 33.5-431 mg/dL), while mean plasma glucose value measured by the laboratory reference method was 138.13+78.6 mg/dL (range, 43-451 mg/dL). Correlation coefficient was 0.99, with a 95% confidence interval of 0.98 to 0.99. Coefficient of determination (R2) was 0.97, and intraclass correlation coefficient was 0.99 with a 95% CI of 0.98 to 0.99.

Conclusions: The tested glucose meter (StatStrip) shows a good linear association, precision, and accuracy when compared to the laboratory reference method. This device is adequate for glucose monitoring.