Evaluation of a glucose meter against analytical quality specifications for hospital use

Background: The value of glucose meters in point of care testing (POCT) by medical professionals and self monitoring of blood glucose (SMBG) by patients is well established. We evaluated the SureSteppFlexx glucose meter against objective targets for imprecision and total error (TE). Methods: The SureStepFlexx blood glucose system uses a reflectance-based glucose oxidase (GO) method and reports plasma-equivalent glucose values. The reference method was the Beckman LX20 Pro glucose oxidase/oxygen electrode method. Patient samples and commercial aqueous, quality control (QC) material were used to assess imprecision. To determine total error of the meters, results obtained on patient heparinized blood were compared against results obtained by the reference method using plasma. Analyses were carried out by an experienced nurse and technologist. Results: Both operators achieved imprecision of less than or equal to 5% for all measurements. Overall, the percentage of results deviating from the total error targets were 0-21% and 4-13% for the nurse and technologist, respectively. Compared with earlier studies, the percentages of reported results outside the less than or equal to 10% and less than or equal to 5% American Diabetes Association (ADA) criteria are significantly lower. Conclusions: The SureSteppFlexx glucose meter meets analytical quality requirements and is suitable for POCT use in our hospital. We propose a tiered approach and suggest minimum, desirable and optimum total error targets for glucose meters of less than or equal to 5%, 7.9% and 13%, respectively. (C) 2004 Elsevier B.V. All rights reserved.