PubMed | Ascensia Diabetes Care United States, Cantonal Hospital Aarau AG and Ascensia Diabetes Care Deutschland GmbH
Type: Journal Article | Journal: Journal of diabetes science and technology | Year: 2016
This study assesses and demonstrates that CONTOUR XT-BGMS (CXT-BGMS) complies with the requirements of the German (RiliBK) and Swiss (QUALAB) quality control guidelines for point-of-care testing (POCT) and fulfills the ISO15197:2013 accuracy limits criteria under the routine conditions of a hospital point-of care setting. This single-center study was conducted in Switzerland using 105 venous blood samples from hospitalized patients. Each sample was tested in comparison to the hexokinase reference method. Compliance with POCT guidelines was assessed by daily BGMS measurements using control solutions. Accuracy of CXT-BGMS according to ISO limits was 98.41%. All control measurements were within the limits defined by RiliBK (within 11% of target values and root mean square error [RMSE] within RMSE limits), and QUALAB (within 10% of target values).