Home Medicine Application of a point of care creatinine device for trend monitoring in kidney transplant patients: fit for purpose?
Article
Licensed
Unlicensed Requires Authentication

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 , Paul W. Schenk , Sandra van Dijk , Ton J.M. Rövekamp , Anja Kessler , Lothar Siekmann , Ton J. Rabelink and Christa M. Cobbaert EMAIL logo
Published/Copyright: February 19, 2015
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 53 Issue 10

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.

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

Acknowledgments

We thank Nova Biomedical for supplying the StatSensor® creatinine devices and related test materials. Further, we thank Professor Stef van Buuren of the Dutch Organization for Applied Scientific Research (TNO) for thinking along on suitable ways to analyze our creatinine monitoring data.

Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

Financial support: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

References

1. Schaefer HM. Long-term management of the kidney transplant recipient. Blood Purif 2012;33:205–11.10.1159/000334158Search in Google Scholar

2. Hood L, Auffray C. Participatory medicine: a driving force for revolutionizing healthcare. Genome Med 2013;5:110.10.1186/gm514Search in Google Scholar

3. Agarwal R, Bills JE, Hecht TJ, Light RP. Role of home blood pressure monitoring in overcoming therapeutic inertia and improving hypertension control: a systematic review and meta-analysis. Hypertension 2011;57:29–38.10.1161/HYPERTENSIONAHA.110.160911Search in Google Scholar

4. Glynn LG, Murphy AW, Smith SM, Schroeder K, Fahey T. Self-monitoring and other non-pharmacological interventions to improve the management of hypertension in primary care: a systematic review. Br J Gen Pract 2010;60:e476–88.10.3399/bjgp10X544113Search in Google Scholar

5. Gardiner C, Longair I, Pescott MA, Erwin H, Hills J, Machin SJ, et al. Self-monitoring of oral anticoagulation: does it work outside trial conditions? J Clin Pathol 2009;62:168–71.10.1136/jcp.2008.059634Search in Google Scholar

6. Heneghan C, Ward A, Perera R, Bankhead C, Fuller A, Stevens R, et al. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet 2012;379:322–34.10.1016/S0140-6736(11)61294-4Search in Google Scholar

7. Bloomfield HE, Krause A, Greer N, Taylor BC, MacDonald R, Rutks I, et al. Meta-analysis: effect of patient self-testing and self-management of long-term anticoagulation on major clinical outcomes. Ann Intern Med 2011;154:472–82.10.7326/0003-4819-154-7-201104050-00005Search in Google Scholar

8. Sicotte C, Pare G, Morin S, Potvin J, Moreault MP. Effects of home telemonitoring to support improved care for chronic obstructive pulmonary diseases. Telemed J E Health 2011;17:95–103.10.1089/tmj.2010.0142Search in Google Scholar

9. McManus RJ, Mant J, Bray EP, Holder R, Jones MI, Greenfield S, et al. Telemonitoring and self-management in the control of hypertension (TASMINH2): a randomised controlled trial. Lancet 2010;376:163–72.10.1016/S0140-6736(10)60964-6Search in Google Scholar

10. Barnard KD, Young AJ, Waugh NR. Self monitoring of blood glucose – a survey of diabetes UK members with type 2 diabetes who use SMBG. BMC Res Notes 2010;3:318.10.1186/1756-0500-3-318Search in Google Scholar PubMed PubMed Central

11. Braun S, Spannagl M, Voller H. Patient self-testing and self-management of oral anticoagulation. Anal Bioanal Chem 2009;393:1463–71.10.1007/s00216-008-2225-3Search in Google Scholar

12. Ryan F, Byrne S, O’Shea S. Randomized controlled trial of supervised patient self-testing of warfarin therapy using an internet-based expert system. J Thromb Haemost 2009;7: 1284–90.10.1111/j.1538-7836.2009.03497.xSearch in Google Scholar

13. Jaana M, Pare G. Home telemonitoring of patients with diabetes: a systematic assessment of observed effects. J Eval Clin Pract 2007;13:242–53.10.1111/j.1365-2753.2006.00686.xSearch in Google Scholar

14. Cromheecke ME, Levi M, Colly LP, de Mol BJ, Prins MH, Hutten BA, et al. Oral anticoagulation self-management and management by a specialist anticoagulation clinic: a randomised cross-over comparison. Lancet 2000;356:97–102.10.1016/S0140-6736(00)02470-3Search in Google Scholar

15. Jones MI, Greenfield SM, Bray EP, Baral-Grant S, Hobbs FD, Holder R, et al. Patients’ experiences of self-monitoring blood pressure and self-titration of medication: the TASMINH2 trial qualitative study. Br J Gen Pract 2012;62:e135–42.10.3399/bjgp12X625201Search in Google Scholar PubMed PubMed Central

16. Aumatell A, Sharpe D, Reed W. Validation of the StatSensor creatinine meter for testing blood before contrast computed tomography studies. Point Care J Near-Patient Testing Technol 2010;9:25–31.10.1097/POC.0b013e3181d2d8a5Search in Google Scholar

17. Korpi-Steiner NL, Williamson EE, Karon BS. Comparison of three whole blood creatinine methods for estimation of glomerular filtration rate before radiographic contrast administration. Am J Clin Pathol 2009;132:920–6.10.1309/AJCPTE5FEY0VCGOZSearch in Google Scholar PubMed

18. Haneder S, Gutfleisch A, Meier C, Brade J, Hannak D, Schoenberg J, et al. Evaluation of a handheld creatinine measurement device for real-time determination of serum creatinine in radiology departments. World J Radiol 2012;4:328–34.10.4329/wjr.v4.i7.328Search in Google Scholar PubMed PubMed Central

19. Straseski JA, Lyon ME, Clarke W, Dubois JA, Phelan LA, Lyon AW. Investigating interferences of a whole-blood point-of-care creatinine analyzer: comparison to plasma enzymatic and definitive creatinine methods in an acute-care setting. Clin Chem 2011;57:1566–73.10.1373/clinchem.2011.165480Search in Google Scholar PubMed

20. Shephard M, Peake M, Corso O, Shephard A, Mazzachi B, Spaeth B, et al. Assessment of the Nova StatSensor whole blood point-of-care creatinine analyzer for the measurement of kidney function in screening for chronic kidney disease. Clin Chem Lab Med 2010;48:1113–9.10.1515/CCLM.2010.238Search in Google Scholar PubMed

21. Horvath AR, Lord SJ, StJohn A, Sandberg S, Cobbaert CM, Lorenz S, et al. From biomarkers to medical tests: the changing landscape of test evaluation. Clin Chim Acta 2014;427:49–57.10.1016/j.cca.2013.09.018Search in Google Scholar PubMed

22. Fraser CG. Biological variation: from principles to practice. Washington: AACC Press, 2002.Search in Google Scholar

23. Chandraker A. Overview of care of the adult kidney transplant recipient. In: UpToDate, Brennan CD (ed), UpToDate, Waltham, MA, www.uptodate.com. Accessed 22 November 2014.Search in Google Scholar

24. Craig JA, Chaplin S, Jenks M. Warfarin monitoring economic evaluation of point of care self-monitoring compared to clinic settings. J Med Econ 2014;17:184–90.10.3111/13696998.2013.877468Search in Google Scholar PubMed

25. Gerkens S, Gailly J, Obyn C, Devriese S, Cleemput I. Economic evaluation of the use of point-of-care devices in patients with long term oral anticoagulation. J Thromb Thrombolysis 2012;34:300–9.10.1007/s11239-012-0715-9Search in Google Scholar PubMed

26. Health Quality Ontario. Point-of-care International Normalized Ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy: an evidence-based analysis. Ont Health Technol Assess Ser 2009;9:1–114.Search in Google Scholar

27. Kaambwa B, Bryan S, Jowett S, Mant J, Bray EP, Hobbs FR, et al. Telemonitoring and self-management in the control of hypertension (TASMINH2): a cost-effectiveness analysis. Eur J Prev Cardiol 2014;21:1517–30.10.1177/2047487313501886Search in Google Scholar PubMed

28. Lafata JE, Martin SA, Kaatz S, Ward RE. Anticoagulation clinics and patient self-testing for patients on chronic warfarin therapy: a cost-effectiveness analysis. J Thromb Thrombolysis 2000;9(Suppl 1):S13–9.Search in Google Scholar

29. O’Shea SI, Arcasoy MO, Samsa G, Cummings SE, Thames EH, Surwit RS, et al. Direct-to-patient expert system and home INR monitoring improves control of oral anticoagulation. J Thromb Thrombolysis 2008;26:14–21.10.1007/s11239-007-0068-ySearch in Google Scholar PubMed

30. van dM V, van Stel HF, Bakker MJ, Roldaan AC, Assendelft WJ, Sterk PJ, et al. Weekly self-monitoring and treatment adjustment benefit patients with partly controlled and uncontrolled asthma: an analysis of the SMASHING study. Respir Res 2010;11:74.10.1186/1465-9921-11-74Search in Google Scholar PubMed PubMed Central

31. Green BB, Cook AJ, Ralston JD, Fishman PA, Catz SL, Carlson J, et al. Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial. J Am Med Assoc 2008;299:2857–67.10.1001/jama.299.24.2857Search in Google Scholar PubMed PubMed Central

32. Van Gaalen JL, Hashimoto S, Sont JK. Telemanagement in asthma: an innovative and effective approach. Curr Opin Allergy Clin Immunol 2012;12:235–40.10.1097/ACI.0b013e3283533700Search in Google Scholar PubMed

33. Gadisseur AP, Kaptein AA, Breukink-Engbers WG, van der Meer FJ, Rosendaal FR. Patient self-management of oral anticoagulant care vs. management by specialized anticoagulation clinics: positive effects on quality of life. J Thromb Haemost 2004;2:584–91.10.1111/j.1538-7836.2004.00659.xSearch in Google Scholar PubMed

34. Sawicki PT, Glaser B, Kleespies C, Stubbe J, Schmitz N, Kaiser T, et al. Self-management of oral anticoagulation: long-term results. J Intern Med 2003;254:515–6.10.1046/j.1365-2796.2003.01215.xSearch in Google Scholar PubMed

Supplemental Material

The online version of this article (DOI: 10.1515/cclm-2014-0932) offers supplementary material, available to authorized users.

Received: 2014-9-20
Accepted: 2015-1-18
Published Online: 2015-2-19
Published in Print: 2015-9-1

©2015 by De Gruyter

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. New endocrine biomarkers and cardiovascular disease: is it time for routinely screening?
  4. Reviews
  5. Quantitative detection of amyloid-β peptides by mass spectrometry: state of the art and clinical applications
  6. Recent advances in biomarkers for Parkinson’s disease focusing on biochemicals, omics and neuroimaging
  7. Mini Review
  8. Serum calcitonin negative medullary thyroid carcinoma: a systematic review of the literature
  9. Genetics and Molecular Diagnostics
  10. ABCB1 (MDR-1) pharmacogenetics of tacrolimus in renal transplanted patients: a Next Generation Sequencing approach
  11. Novel association of FCGR2A polymorphism with age-related macular degeneration (AMD) and development of a novel CFH real-time genotyping method
  12. General Clinical Chemistry and Laboratory Medicine
  13. Assessing quality on the Sigma scale from proficiency testing and external quality assessment surveys
  14. Combining antibody tests and taking into account antibody levels improves serologic diagnosis of celiac disease
  15. Application of a point of care creatinine device for trend monitoring in kidney transplant patients: fit for purpose?
  16. LC-MS/MS method for hepcidin-25 measurement in human and mouse serum: clinical and research implications in iron disorders
  17. The relationship of fibroblast growth factors 21 and 23 and α-Klotho with platelet activity measured by platelet volume indices
  18. Neurofilament medium polypeptide (NFM) protein concentration is increased in CSF and serum samples from patients with brain injury
  19. Methods to identify saline-contaminated electrolyte profiles
  20. An international study of how laboratories handle and evaluate patient samples after detecting an unexpected APTT prolongation
  21. The influence of excipients commonly used in freeze drying on whole blood coagulation dynamics assessed by rotational thromboelastometry
  22. Reference Values and Biological Variations
  23. Biological variation of plasma osmolality obtained with capillary versus venous blood
  24. Mining of hospital laboratory information systems: a model study defining age- and gender-specific reference intervals and trajectories for plasma creatinine in a pediatric population
  25. Cancer Diagnostics
  26. Fascin is a circulating tumor marker for head and neck cancer as determined by a proteomic analysis of interstitial fluid from the tumor microenvironment
  27. Diabetes
  28. First trimester concentrations of the TTR-RBP4-retinol complex components as early markers of insulin-treated gestational diabetes mellitus
  29. Corrigendum
  30. Corrigendum to: Performance criteria and quality indicators for the pre-analytical phase
  31. Letters to the Editors
  32. Pediatric reference intervals for calculated free testosterone, bioavailable testosterone and free androgen index in the CALIPER cohort
  33. Two novel genomic rearrangements identified in suicide subjects using a-CGH array
  34. Association between physical fitness and mean platelet volume in professional soccer players
  35. Laboratory biomarkers and frailty: presentation of the FRAILOMIC initiative
  36. Spuriously high platelet counts by various automated hematology analyzers in a patient with disseminated intravascular coagulation
  37. To avoid fasting time, more risk than benefits
  38. Daily communication decreases the number of pre-analytical errors in primary care
  39. On-line flagging monitoring – a new quality management tool for the analytical phase
  40. Diagnosis of α1-antitrypsin deficiency using capillary zone electrophoresis
  41. FTL gene mutation and persistent hyperferritinemia without iron deficiency anemia after phlebotomy
  42. Analytical and clinical evaluation of a new immunoassay for therapeutic drug monitoring of etanercept
https://doi.org/10.1515/cclm-2014-0932
Keywords for this article
creatinine; kidney transplantation; metrological traceability; reference standardization; self-monitoring; test purpose

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. New endocrine biomarkers and cardiovascular disease: is it time for routinely screening?
  4. Reviews
  5. Quantitative detection of amyloid-β peptides by mass spectrometry: state of the art and clinical applications
  6. Recent advances in biomarkers for Parkinson’s disease focusing on biochemicals, omics and neuroimaging
  7. Mini Review
  8. Serum calcitonin negative medullary thyroid carcinoma: a systematic review of the literature
  9. Genetics and Molecular Diagnostics
  10. ABCB1 (MDR-1) pharmacogenetics of tacrolimus in renal transplanted patients: a Next Generation Sequencing approach
  11. Novel association of FCGR2A polymorphism with age-related macular degeneration (AMD) and development of a novel CFH real-time genotyping method
  12. General Clinical Chemistry and Laboratory Medicine
  13. Assessing quality on the Sigma scale from proficiency testing and external quality assessment surveys
  14. Combining antibody tests and taking into account antibody levels improves serologic diagnosis of celiac disease
  15. Application of a point of care creatinine device for trend monitoring in kidney transplant patients: fit for purpose?
  16. LC-MS/MS method for hepcidin-25 measurement in human and mouse serum: clinical and research implications in iron disorders
  17. The relationship of fibroblast growth factors 21 and 23 and α-Klotho with platelet activity measured by platelet volume indices
  18. Neurofilament medium polypeptide (NFM) protein concentration is increased in CSF and serum samples from patients with brain injury
  19. Methods to identify saline-contaminated electrolyte profiles
  20. An international study of how laboratories handle and evaluate patient samples after detecting an unexpected APTT prolongation
  21. The influence of excipients commonly used in freeze drying on whole blood coagulation dynamics assessed by rotational thromboelastometry
  22. Reference Values and Biological Variations
  23. Biological variation of plasma osmolality obtained with capillary versus venous blood
  24. Mining of hospital laboratory information systems: a model study defining age- and gender-specific reference intervals and trajectories for plasma creatinine in a pediatric population
  25. Cancer Diagnostics
  26. Fascin is a circulating tumor marker for head and neck cancer as determined by a proteomic analysis of interstitial fluid from the tumor microenvironment
  27. Diabetes
  28. First trimester concentrations of the TTR-RBP4-retinol complex components as early markers of insulin-treated gestational diabetes mellitus
  29. Corrigendum
  30. Corrigendum to: Performance criteria and quality indicators for the pre-analytical phase
  31. Letters to the Editors
  32. Pediatric reference intervals for calculated free testosterone, bioavailable testosterone and free androgen index in the CALIPER cohort
  33. Two novel genomic rearrangements identified in suicide subjects using a-CGH array
  34. Association between physical fitness and mean platelet volume in professional soccer players
  35. Laboratory biomarkers and frailty: presentation of the FRAILOMIC initiative
  36. Spuriously high platelet counts by various automated hematology analyzers in a patient with disseminated intravascular coagulation
  37. To avoid fasting time, more risk than benefits
  38. Daily communication decreases the number of pre-analytical errors in primary care
  39. On-line flagging monitoring – a new quality management tool for the analytical phase
  40. Diagnosis of α1-antitrypsin deficiency using capillary zone electrophoresis
  41. FTL gene mutation and persistent hyperferritinemia without iron deficiency anemia after phlebotomy
  42. Analytical and clinical evaluation of a new immunoassay for therapeutic drug monitoring of etanercept
Sign up now to receive a 20% welcome discount
Institutional Access
How does access work?
Winner of the OpenAthens UX Award 2026
Winner of the OpenAthens UX Award 2026
Have an idea on how to improve our website?
Please write us.
© 2026 De Gruyter Brill
Downloaded on 13.3.2026 from https://www.degruyterbrill.com/document/doi/10.1515/cclm-2014-0932/html
Scroll to top button