Evaluation of CareSens POCT Devices for Glucose Testing in the Routine Hospital Setting

Glucose meters are used routinely in hospital wards to manage blood glucose levels in patients requiring frequent monitoring of blood glucose.

Our institution has 50 POC instruments utilized by diverse population of all ages and medical conditions. The primary objective of our study was to investigate whether all these CareSens glucose meters (I-sense Inc, Seoul, South Korea) results in hospitalized patients during routine clinical care jointly satisfy the specified quality specifications, as defined by Clinical and Laboratory Standards Institute (CLSI) guideline POCT12-A3.

The records of hospitalized patients who underwent simultaneous measures of glucose levels with both glucose meters and a central laboratory analyser between January and June 2013 were retrospectively analysed. We also performed a prospective evaluation of the accuracy of the CareSens glucose Strip.

Glucose concentrations measured in 840 patients ranged from 1.66 to 31.72 mmol/L The Bland-Altman difference plot between the auto analyser and all the 50 CareSens glucosemeters revealed a mean bias of -2.2%, with analytical biases for the two methods varying from -31.1% to 26.8%. Eighty four percent of the glucose meter's glucose values were within ± 12.5% for values 5.54 mmol/L of the comparative laboratory glucose values and 93% of the results were within 20% of the reference for glucose >4.2 mmol/L and 65% of the results were within 0.8 mmol/L for glucose <4.2 mmol/L.

CareSens glucose meter readings in hospital settings, especially in hypoglycaemic patients, should be confirmed by central laboratory analysers whenever possible.