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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 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

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1437-4331
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Volume 53, Issue 10

Issues

Application of a point of care creatinine device for trend monitoring in kidney transplant patients: fit for purpose?

Céline L. van Lint / Paul J.M. van der Boog / Fred P.H.T.M. Romijn
  • Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Centre, Leiden, The Netherlands
  • Other articles by this author:
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/ Paul W. Schenk
  • Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Centre, Leiden, The Netherlands
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/ Sandra van Dijk / Ton J.M. Rövekamp
  • Department of Technology in Healthcare, Prevention and Health, Dutch Organization for Applied Scientific Research (TNO), Leiden, The Netherlands
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/ Anja Kessler
  • Institute of Clinical Biochemistry and Pharmacology, University Hospital of Bonn, Bonn, Germany
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/ Lothar Siekmann
  • Institute of Clinical Biochemistry and Pharmacology, University Hospital of Bonn, Bonn, Germany
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/ Ton J. Rabelink / Christa M. Cobbaert
  • Corresponding author
  • Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Centre, Leiden, The Netherlands
  • Email
  • Other articles by this author:
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Published Online: 2015-02-19 | DOI: https://doi.org/10.1515/cclm-2014-0932

Abstract

Background: The StatSensor® Xpress-i™, a point-of-care system for blood creatinine measurement, offers patients the possibility of self-monitoring creatinine. In this study, the analytical performance of the StatSensor® for both detecting current renal function and monitoring renal (dys)function in kidney transplant patients was examined.

Methods: Accuracy of the StatSensor® with capillary and venous whole blood was evaluated and compared to an isotopic dilution mass spectrometry (IDMS)-traceable enzymatic creatinine test in venous serum (n=138). Twenty Li-heparin samples were compared to the IDMS reference method performed by a Joint Committee for Traceability in Laboratory Medicine (JCTLM)-listed reference laboratory (RfB, Bonn, Germany). To evaluate StatSensor®’s suitability to monitor kidney function, both venous and capillary samples were obtained in 20 hospitalized transplantation patients. Venous samples were analyzed with an IDMS-traceable enzymatic test, capillary samples were measured using the StatSensor®. For all 2-day intervals, percentage change in creatinine was compared between both methods.

Results: The StatSensor® did not meet total allowable error criterion of 6.9%. Average overall CVa for the StatSensor® was 10.4% and 5.2% for capillary and venous whole blood results, respectively. Overall CVa for the central laboratory serum creatinine method was <1.5%. For monitoring renal (dys)function, total agreement of the StatSensor® with an IDMS-traceable enzymatic test was 68% using a 10% Δ change. No significant differences were found between the changes observed by both methods.

Conclusions: Capillary blood testing with the StatSensor® is not advisable for determining current renal function with a single creatinine measurement in kidney transplant patients, mainly due to excessive analytical imprecision. However, our results suggest that capillary blood testing with the StatSensor® can be used for daily trend monitoring of kidney function after renal transplantation.

This article offers supplementary material which is provided at the end of the article.

Keywords: creatinine; kidney transplantation; metrological traceability; reference standardization; self-monitoring; test purpose

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About the article

Corresponding author: Dr. Christa M. Cobbaert, PhD, Leiden University Medical Centre, Department of Clinical Chemistry and Laboratory Medicine, PO Box 9600 – Zone E2-P, 2300 RC Leiden, The Netherlands, Phone: +31 71 526 2278/4483, Fax: +31 71 526 6753, E-mail:


Received: 2014-09-20

Accepted: 2015-01-18

Published Online: 2015-02-19

Published in Print: 2015-09-01


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 53, Issue 10, Pages 1547–1556, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2014-0932.

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