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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2017: 3.556

CiteScore 2017: 2.34

SCImago Journal Rank (SJR) 2017: 1.114
Source Normalized Impact per Paper (SNIP) 2017: 1.188

Online
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1437-4331
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Volume 50, Issue 9

Issues

Validation of a new generation POCT glucose device with emphasis on aspects important for glycemic control in the hospital care

Snježana Kos
  • Corresponding author
  • Central Laboratory of the Hospital (Maasstad Lab), Department of Clinical Chemistry, Maasstad Hospital, Rotterdam, The Netherlands
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Arie van Meerkerk
  • Central Laboratory of the Hospital (Maasstad Lab), Department of Clinical Chemistry, Maasstad Hospital, Rotterdam, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Joke van der Linden / Theo Stiphout
  • Central Laboratory of the Hospital (Maasstad Lab), Department of Clinical Chemistry, Maasstad Hospital, Rotterdam, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Remi Wulkan
  • Central Laboratory of the Hospital (Maasstad Lab), Department of Clinical Chemistry, Maasstad Hospital, Rotterdam, The Netherlands
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2012-03-16 | DOI: https://doi.org/10.1515/cclm-2011-0900

Abstract

Background: Point-of-care (POC) glucose devices are widely used for insulin-dosage decision-making although such an application is not always permitted. In this study, we have evaluated a new generation of POC glucose device, the HemoCue® Glucose 201DMRT (201DMRT), for its suitability for (tight) glycemic control.

Materials and methods: This study was performed according to the CLSI/STARD criteria. The 201DMRT was compared to the laboratory hexokinase glucose method (Siemens Dimension Vista®). The variation among different POC devices and cuvette lot numbers was examined. Additionally, the influence of the partial pressure of oxygen and hematocrit on glucose measurement was investigated.

Results: The 201DMRT showed a good agreement with the laboratory reference method. This was examined using Deming regression analysis, percentage Bland-Altman plot and a modified Clarke-error grid. The total analytical error at the clinically critical glucose concentrations of 5.6, 7.0 and 11.1 mmol/L (101, 126 and 200 mg/dL) was 6.4%, 4.3% and 3.0%, respectively. The total error among the different POC devices and among different cuvette lot numbers was <6.5%. Glucose measurements on the 201DMRT were not affected by changes in partial pressure of oxygen, whereas changes in hematocrit had influence on the results (3.4% for every 0.10 L/L change in hematocrit).

Conclusions: The 201DMRT device can be used for glycemic control based on analytical results presented. However, the clinical applicability for tight glycemic control must be confirmed in a clinical study.

Keywords: blood glucose; performance; POCT; tight glycemic control

About the article

Corresponding author: Dr. Snježana Kos, Clinical Chemist, Maasstad Hospital Rotterdam, MaasstadLab, Department of Clinical Chemistry, P.O. Box 9100, 3007 AC Rotterdam, The Netherlands Phone: +31 10 2912782, Fax: +31 10 2911038


Received: 2011-12-04

Accepted: 2012-02-24

Published Online: 2012-03-16

Published in Print: 2012-09-01


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 50, Issue 9, Pages 1573–1580, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2011-0900.

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