title: Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting.
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).
authors.affiliation: Cantonal Hospital Aarau AG, Aarau, Switzerland.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Ottiger
authors.affiliation: Cantonal Hospital Aarau AG, Aarau, Switzerland.
authors.forename: Nicole
authors.initials: N
authors.lastname: Gygli
authors.affiliation: Cantonal Hospital Aarau AG, Aarau, Switzerland.
authors.forename: Andreas R
authors.initials: AR
authors.lastname: Huber
authors.affiliation: Ascensia Diabetes Care Deutschland GmbH, Leverkusen, Germany beatriz.fernandez-tresguerres@ascensia.com.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Fernandez-Tresguerres
authors.affiliation: Ascensia Diabetes Care USA, Parsippany, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Pardo
authors.affiliation: Ascensia Diabetes Care Deutschland GmbH, Leverkusen, Germany.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Petruschke
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D006801:Humans; D000067716:Point-of-Care Testing; D011358:Product Surveillance, Postmarketing
chemical_list: D001786:Blood Glucose
keywords: BGMS; Contour XT; ISO 15197; POCT; QUALAB; RiliBÄK