Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting

Cornelia Ottiger; Nicole Gygli; Andreas R Huber; Beatriz Fernandez-Tresguerres; Scott Pardo; Thorsten Petruschke

doi:10.1177/1932296816638854

Performance of a Blood Glucose Monitoring System in a Point-of-Care Setting

J Diabetes Sci Technol. 2016 Jun 28;10(4):939-46. doi: 10.1177/1932296816638854. Print 2016 Jul.

Authors

Cornelia Ottiger¹, Nicole Gygli¹, Andreas R Huber¹, Beatriz Fernandez-Tresguerres², Scott Pardo³, Thorsten Petruschke⁴

Affiliations

¹ Cantonal Hospital Aarau AG, Aarau, Switzerland.
² Ascensia Diabetes Care Deutschland GmbH, Leverkusen, Germany beatriz.fernandez-tresguerres@ascensia.com.
³ Ascensia Diabetes Care USA, Parsippany, USA.
⁴ Ascensia Diabetes Care Deutschland GmbH, Leverkusen, Germany.

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: BGMS; Contour XT; ISO 15197; POCT; QUALAB; RiliBÄK.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Blood Glucose / analysis*
Humans
Point-of-Care Testing*
Product Surveillance, Postmarketing

Substances

Blood Glucose