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Performance of strip-based glucose meters and cassette-based blood gas analyzer for monitoring glucose levels in a surgical intensive care setting

  • Helena Claerhout , Martine De Prins , Dieter Mesotten , Greet Van den Berghe , Chantal Mathieu , Johan Van Eldere and Florent Vanstapel EMAIL logo
Published/Copyright: July 2, 2015
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 54 Issue 1

Abstract

Background: We verified the analytical performance of strip-based handheld glucose meters (GM) for prescription use, in a comparative split-sample protocol using blood gas samples from a surgical intensive care unit (ICU).

Methods: Freestyle Precision Pro (Abbott), StatStrip Connectivity Meter (Nova), ACCU-CHEK Inform II (Roche) were evaluated for recovery/linearity, imprecision/repeatability. The GMs and the ABL90 (Radiometer) blood gas analyzer (BGA) were tested for relative accuracy vs. the comparator hexokinase glucose-6-phosphate-dehydrogenase (HK/G6PDH) assay on a Cobas c702 analyzer (Roche).

Results: Recovery of spiked glucose was linear up to 19.3 mmol/L (347 mg/dL) with a slope of 0.91–0.94 for all GMs. Repeatability estimated by pooling duplicate measurements on samples below (n=9), in (n=51) or above (n=80) the 4.2–5.9 mM (74–106 mg/dL) range were for Freestyle Precision Pro: 4.2%, 4.0%, 3.6%; StatStrip Connectivity Meter: 4.0%, 4.3%, 4.5%; and ACCU-CHEK Inform II: 1.4%, 2.5%, 3.5%. GMs were in agreement with the comparator method. The BGA outperformed the GMs, with a MARD of 3.9% compared to 6.5%, 5.8% and 4.4% for the FreeStyle, StatStrip and ACCU-CHEK, respectively. Zero % of the BGA results deviated more than the FDA 10% criterion as compared to 9.4%, 3.7% and 2.2% for the FreeStyle, StatStrip and ACCU-CHEK, respectively. For all GMs, icodextrin did not interfere. Variation in the putative influence factors hematocrit and O2 tension could not explain observed differences with the comparator method.

Conclusions: GMs quantified blood glucose in whole blood at about the 10% total error criterion, proposed by the FDA for prescription use.

Keywords: blood gas analyzer; glucose; point-of-care testing; POCT prescription testing; strip-based meters; tight glucose control
Corresponding author: Florent Vanstapel, Laboratory Medicine, UZ Leuven, Campus Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium, E-mail: ; and Department of Public Health, Biomedical Sciences Group, KU Leuven, Belgium

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

  2. Research funding: The manufacturers provided GMs and consumables free of charge (Abbott Diagnostics, Belgium and Luxemburg, Wavre, Belgium; Menarini Diagnostics Benelux, Zaventem, Belgium; and Roche Diagnostics Belgium, Vilvoorde, Belgium). All experiments and the preparation and submission of this report were conducted without interference by the manufacturers. DM holds a senior clinical investigator fellowship from the FWO Research Foundation – Flanders. Supported by IWT-TBM program (100793).

  3. Employment or leadership: FV received a travel grant from Roche. Results were in part presented as an abstract at the 2nd Belgian National POCT Symposium [44].

  4. Honorarium: None declared.

  5. 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.

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Received: 2014-12-30
Accepted: 2015-5-28
Published Online: 2015-7-2
Published in Print: 2016-1-1

©2016 by De Gruyter

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https://doi.org/10.1515/cclm-2014-1289
Keywords for this article
blood gas analyzer; glucose; point-of-care testing; POCT prescription testing; strip-based meters; tight glucose control

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Building a bridge to safe diagnosis in health care. The role of the clinical laboratory
  4. Capillary electrophoresis for the screening and diagnosis of inherited hemoglobin disorders. Ready for prime time?
  5. Reviews
  6. Hyperuricemia as risk factor for coronary heart disease incidence and mortality in the general population: a systematic review and meta-analysis
  7. Towards biomarker-based tests that can facilitate decisions about prevention and management of preeclampsia in low-resource settings
  8. Mini Review
  9. Clinical relevance of sST2 in cardiac diseases
  10. General Clinical Chemistry and Laboratory Medicine
  11. Preservation of urine free catecholamines and their free O-methylated metabolites with citric acid as an alternative to hydrochloric acid for LC-MS/MS-based analyses
  12. Performance characteristics of the VIDAS® 25-OH Vitamin D Total assay – comparison with four immunoassays and two liquid chromatography-tandem mass spectrometry methods in a multicentric study
  13. Differentiation of acute pyelonephritis from other febrile states in children using urinary neutrophil gelatinase-associated lipocalin (uNGAL)
  14. Early postoperative C-terminal agrin fragment (CAF) serum levels predict graft loss and proteinuria in renal transplant recipients
  15. Homocitrulline: a new marker for differentiating acute from chronic renal failure
  16. Hematology and Coagulation
  17. Development of hemoglobin typing control materials for laboratory investigation of thalassemia and hemoglobinopathies
  18. Comparison of capillary electrophoresis and high performance liquid chromatography for detection and quantification of hemoglobin New York
  19. Prevalence of hemostatic alterations in patients with recurrent spontaneous subconjunctival hemorrhage
  20. Reference Values and Biological Variations
  21. Reference intervals for 24 laboratory parameters determined in 24-hour urine collections
  22. First trimester PAPP-A2, PAPP-A and hCGβ in small-for-gestational-age pregnancies
  23. Cancer Diagnostics
  24. Clinical utility of one versus two faecal immunochemical test samples in the detection of advanced colorectal neoplasia in symptomatic patients
  25. Cardiovascular Diseases
  26. Time from symptom onset influences high-sensitivity troponin T diagnostic accuracy for the diagnosis of acute myocardial infarction
  27. Prognostic significance of serum albumin level changes in acute ischemic stroke: the role of biological and analytical variation
  28. Correlates of serum hepcidin levels and its association with cardiovascular disease in an elderly general population
  29. Infectious Diseases
  30. Usefulness of several biomarkers in the management of septic patients: C-reactive protein, procalcitonin, presepsin and mid-regional pro-adrenomedullin
  31. Diabetes
  32. Performance of strip-based glucose meters and cassette-based blood gas analyzer for monitoring glucose levels in a surgical intensive care setting
  33. Accuracy and precision assessment of a new blood glucose monitoring system
  34. Acknowledgment
  35. Acknowledgment
  36. Letter to the Editors
  37. Glypican-1 as a highly sensitive and specific pancreatic cancer biomarker
  38. Platelet microRNAs are not modulated by systemic heparin in acute coronary syndromes
  39. Concomitant appearance of two false positive peaks with a true monoclonal one in a patient with plasma cell myeloma
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  42. Liposomal interference on Sysmex XN-series body fluid mode
  43. Development of an immunomagnetic beads-based test and its application in influenza surveillance
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