Validation of cobas® pulse point-of-care testing device for blood glucose monitoring.

The aim of this study was to validate the blood glucose point-of-care system, cobas^® pulse (Roche Diagnostics GmbH), which is the successor to the Accu-Chek^® Inform II system (Roche Diagnostics GmbH). Since the cobas^® pulse device is intended to replace an existing device from the same manufacturer, we found it highly relevant to perform an industry-independent validation regarding accuracy and comparability with existing glucose measurement systems. From 40 randomly selected, non-fasting adults capillary and venous blood was drawn simultaneously. Correlation and agreement was evaluated by comparing capillary blood glucose on cobas^® pulse to plasma glucose on cobas^® 8000 (Roche Diagnostics GmbH) and capillary blood glucose on ABL800 Flex (Radiometer, Denmark), respectively. The cobas^® pulse generally showed good agreement with both comparison methods, although the agreement between cobas^® pulse and ABL800 Flex was better (bias -0.01 mmol/L) than between cobas^® pulse and cobas^® 8000 (bias 0.61 mmol/L). Differences between measurements of low blood glucose levels (range 0.5 to 4.8 mmol/L) and higher blood glucose levels (range 9.7 to 15.3 mmol/L) when comparing cobas^® pulse to ABL800 Flex was also within allowable limits. Altogether, the validation study demonstrated a clinically satisfactory performance of the cobas^® pulse point-of-care device.