Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting
Open Access
- 16 March 2016
- journal article
- research article
- Published by SAGE Publications in Journal of Diabetes Science and Technology
- Vol. 10 (4), 939-946
- https://doi.org/10.1177/1932296816638854
Abstract
This study assesses and demonstrates that CONTOUR® XT-BGMS (CXT-BGMS) complies with the requirements of the German (RiliBÄK) 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 RiliBÄK (within ± 11% of target values and root mean square error [RMSE] within RMSE limits), and QUALAB (within ± 10% of target values).Keywords
This publication has 16 references indexed in Scilit:
- Accuracy Evaluation of Four Blood Glucose Monitoring Systems in Unaltered Blood Samples in the Low Glycemic Range and Blood Samples in the Concentration Range Defined by ISO 15197Diabetes Technology & Therapeutics, 2015
- How Should Blood Glucose Meter System Analytical Performance Be Assessed?Journal of Diabetes Science and Technology, 2015
- A Multicenter Performance Evaluation of a Blood Glucose Monitoring System in 21 Leading Hospitals in SpainJournal of Diabetes Science and Technology, 2015
- Point-of-Care Blood Glucose Meter Accuracy in the Hospital SettingDiabetes Spectrum, 2014
- Evaluation of 12 Blood Glucose Monitoring Systems for Self-Testing: System Accuracy and Measurement ReproducibilityDiabetes Technology & Therapeutics, 2014
- A New Test Strip Technology Platform for Self-Monitoring of Blood GlucoseJournal of Diabetes Science and Technology, 2013
- AbstractsJournal of Diabetes Science and Technology, 2013
- Effects of Acute Insulin-Induced Hypoglycemia on Indices of InflammationDiabetes Care, 2010
- Regional cerebral blood flow in IDDM patients: Effects of diabetes and of recurrent severe hypoglycaemiaDiabetologia, 1994
- STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENTThe Lancet, 1986