Analytical performance and user-friendliness of cobas pulse glucose meter in the hands of the intended users.

Abstract

Diabetes is a growing global health concern affecting millions worldwide. Glucose measurement remains a cornerstone in the diagnosis, monitoring, and management of this disease. Considering that numerous point-of-care (POC) devices for glucose measurements are available, systematic evaluation of their analytical performance and user-friendliness is essential. This study presents the findings of an independent evaluation of the cobas pulse glucose meter (Roche Diagnostics GmbH) conducted by the Scandinavian evaluation of laboratory equipment for point of care testing (SKUP). The study, which assessed both the analytical performance and user-friendliness, included 217 participants with diabetes and was conducted in both a hospital laboratory and primary healthcare settings. Capillary whole blood measurements were compared to a plasma glucose hexokinase method at Vejle hospital, Denmark. Certified reference materials from the National Institute of Standards and Technology (NIST) were used to correct all sample results. Repeatability and accuracy were assessed against predefined analytical performance specifications, and user-friendliness was evaluated using a structured questionnaire developed by SKUP. The cobas pulse demonstrated good repeatability (CV: 1.8-4.0%) and fulfilled the specification for accuracy, with minimal bias (maximum +0.16 mmol/L in the 7-10 mmol/L range). Haematocrit had no significant effect within the tested range (5-70%). User-friendliness was rated satisfactory, attributed to intuitive operation, rapid analysis times, and effective quality control features. In conclusion, the cobas pulse glucose meter met the performance criteria for professional use in clinical and primary care settings, supporting its suitability in near-patient glucose monitoring.