Validation of a new generation POCT glucose device with emphasis on aspects important for glycemic control in the hospital care

Background: Point-of-care (POC) glucose devices are widely used for insulin-dosage decision-making although such an application is not always permitted. In this study, we have evaluated a new generation of POC glucose device, the HemoCue® Glucose 201DMRT (201DMRT), for its suitability for (tight) glycemic control. Materials and methods: This study was performed according to the CLSI/STARD criteria. The 201DMRT was compared to the laboratory hexokinase glucose method (Siemens Dimension Vista®). The variation among different POC devices and cuvette lot numbers was examined. Additionally, the infl uence of the partial pressure of oxygen and hematocrit on glucose measurement was investigated. Results: The 201DMRT showed a good agreement with the laboratory reference method. This was examined using Deming regression analysis, percentage Bland-Altman plot and a modified Clarke-error grid. The total analytical error at the clinically critical glucose concentrations of 5.6, 7.0 and 11.1 mmol/L (101, 126 and 200 mg/dL) was 6.4 %, 4.3 % and 3.0 %, respectively. The total error among the different POC devices and among different cuvette lot numbers was < 6.5 %. Glucose measurements on the 201DMRT were not affected by changes in partial pressure of oxygen, whereas changes in hematocrit had infl uence on the results (3.4 % for every 0.10 L/L change in hematocrit). Conclusions: The 201DMRT device can be used for glycemic control based on analytical results presented. However, the clinical applicability for tight glycemic control must be confirmed in a clinical study.

• View at Publisher
• View at Pubmed
• View at Scopus
• View at Web of Science