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Blood Gas Analyzer Accuracy of Glucose Measurements

      Abstract

      Objective

      To investigate the comparability of glucose levels measured with blood gas analyzers (BGAs) and by central laboratories (CLs).

      Material and Methods

      Glucose measurements obtained between June 1, 2007, and March 1, 2016, at the Vanderbilt University Medical Center were reviewed. The agreement between CL and BGA results were assessed using Bland-Altman, consensus error grid (CEG), and surveillance error grid (SEG) analyses. We further analyzed the BGAs’ performance against the US Food and Drug Administration (FDA) 2014 draft guidance and 2016 final guidance for blood glucose monitoring and the International Organization for Standardization (ISO) 15197:2013 standard.

      Results

      We analyzed 2671 paired glucose measurements, including 50 pairs of hypoglycemic values (1.9%). Bland-Altman analysis yielded a mean bias of −3.1 mg/dL, with 98.1% of paired values meeting the 95% limits of agreement. In the hypoglycemic range, the mean bias was −0.8 mg/dL, with 100% of paired values meeting the 95% limits of agreement. When using CEG analysis, 99.9% of the paired values fell within the no risk zone. Similar results were found using SEG analysis. For the FDA 2014 draft guidance, our data did not meet the target compliance rate. For the FDA 2016 final guidance, our data partially met the target compliance rate. For the ISO standard, our data met the target compliance rate.

      Conclusion

      In this study, the agreement for glucose measurement between common BGAs and CL instruments met the ISO 2013 standard. However, BGA accuracy did not meet the stricter requirements of the FDA 2014 draft guidance or 2016 final guidance. Fortunately, plotting these results on either the CEG or the SEG revealed no results in either the great or extreme clinical risk zones.

      Abbreviations and Acronyms:

      BA (Bland-Altman), BGA (blood gas analyzer), BGM (blood glucose meter), CEG (consensus error grid), CL (central laboratory), CMS (Centers for Medicare and Medicaid Services), FDA (Food and Drug Administration), ISO (International Organization for Standardization), LOA (limits of agreement), POC (point-of-care), SEG (surveillance error grid), TAT (turnaround time)
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      References

        • Van den Berghe G.
        • Wouters P.
        • Weekers F.
        • et al.
        Intensive insulin therapy in critically ill patients.
        N Engl J Med. 2001; 345: 1359-1367
        • Van den Berghe G.
        • Wilmer A.
        • Hermans G.
        • et al.
        Intensive insulin therapy in the medical ICU.
        N Engl J Med. 2006; 354: 449-461
        • ADVANCE Collaborative Group
        Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes.
        N Engl J Med. 2008; 358: 2560-2572
        • Le H.T.
        • Harris N.S.
        • Estilong A.J.
        • Olson A.
        • Rice M.J.
        Blood glucose measurement in the intensive care unit: what is the best method?.
        J Diabetes Sci Technol. 2013; 7: 489-499
        • Clain J.
        • Ramar K.
        • Surani S.R.
        Glucose control in critical care.
        World J Diabetes. 2015; 6: 1082-1091
        • Schnell O.
        • Hanefeld M.
        • Monnier L.
        Self-monitoring of blood glucose: a prerequisite for diabetes management in outcome trials.
        J Diabetes Sci Technol. 2014; 8: 609-614
        • Martin S.
        • Schneider B.
        • Heinemann L.
        • et al.
        Self-monitoring of blood glucose in type 2 diabetes and long-term outcome: an epidemiological cohort study.
        Diabetologia. 2006; 49: 271-278
        • Howanitz P.J.
        • Jones B.A.
        Comparative analytical costs of central laboratory glucose and bedside glucose testing: a College of American Pathologists Q-Probes study.
        Arch Pathol Lab Med. 2004; 128: 739-745
        • Rajendran R.
        • Rayman G.
        Point-of-care blood glucose testing for diabetes care in hospitalized patients: an evidence-based review.
        J Diabetes Sci Technol. 2014; 8: 1081-1090
        • Rice M.J.
        • Pitkin A.D.
        • Coursin D.B.
        Glucose measurement in the operating room: more complicated than it seems.
        Anesth Analg. 2010; 110: 1056-1065
        • Rice M.J.
        • Coursin D.B.
        Glucose meters: here today, gone tomorrow?.
        Crit Care Med. 2016; 44: e97-e100
        • US Food and Drug Administration
        Blood glucose monitoring test system for prescription point-of-care use: draft guidance for industry and Food and Drug Administration staff.
        (Draft issued January 7, 2014. Accessed June 2, 2016.)
      1. Nova StatStrip Xpress Glucose Hospital Meter System Receives FDA Clearance Use with Critically Ill Patients [press release].
        (Issued May 26, 2015. Accessed June 21, 2016)
        • Klonoff D.C.
        • Draznin B.
        • Drincic A.
        • et al.
        PRIDE statement on the need for a moratorium on the CMS plan to cite hospitals for performing point-of-care capillary blood glucose monitoring on critically ill patients.
        J Clin Endocrinol Metab. 2015; 100: 3607-3612
        • Hamilton T.E.
        • Center for Clinical Standards and Quality/Survey & Certification Group
        Temporary Withdrawal-S&C: 15-11-CLIA and Reissuance as Draft, with Draft Clarifications. Centers for Medicare and Medicaid Services website.
        (Published March 13, 2015. Accessed May 7, 2016)
        • Uyanik M.
        • Sertoglu E.
        • Kayadibi H.
        • et al.
        Comparison of blood gas, electrolyte and metabolite results measured with two different blood gas analyzers and a core laboratory analyzer.
        Scand J Clin Lab Invest. 2015; 75: 97-105
        • Oliver P.
        • Fernandez-Calle P.
        • Rico N.
        • et al.
        Analytical performance evaluation and comparability of patient results within a point-of-care blood gas network.
        Point of Care. 2013; 12: 144-149
        • Leino A.
        • Kurvinen K.
        Interchangeability of blood gas, electrolyte and metabolite results measured with point-of-care, blood gas and core laboratory analyzers.
        Clin Chem Lab Med. 2011; 49: 1187-1191
        • Luukkonen A.A.
        • Lehto T.M.
        • Hedberg P.S.
        • Vaskivuo T.E.
        Evaluation of a hand-held blood gas analyzer for rapid determination of blood gases, electrolytes and metabolites in intensive care setting.
        Clin Chem Lab Med. 2016; 54: 585-594
        • Uysal E.
        • Acar Y.A.
        • Kutur A.
        • Cevik E.
        • Salman N.
        • Tezel O.
        How reliable are electrolyte and metabolite results measured by a blood gas analyzer in the ED?.
        Am J Emerg Med. 2016; 34: 419-424
        • US Food and Drug Administration
        Blood glucose monitoring test system for prescription point-of-care use: guidance for industry and Food and Drug Administration staff.
        (Issued October 11, 2016. Accessed December 30, 2016.)
        • International Organization for Standardization
        ISO 15197:2013: in vitro diagnostic test systems – requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus.
        (Published May 2013. Accessed on July 8, 2016)
        • Parkes J.L.
        • Slatin S.L.
        • Pardo S.
        • Ginsberg B.H.
        A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose.
        Diabetes Care. 2000; 23: 1143-1148
        • Klonoff D.C.
        • Lias C.
        • Vigersky R.
        • et al.
        • Error Grid Panel
        The surveillance error grid.
        J Diabetes Sci Technol. 2014; 8: 658-672
        • Altman D.G.
        • Bland J.M.
        Measurement in medicine: the analysis of method comparison studies.
        Statistician. 1983; 32: 307-317
        • Inoue S.
        • Egi M.
        • Kotani J.
        • Morita K.
        Accuracy of blood-glucose measurements using glucose meters and arterial blood gas analyzers in critically ill adult patients: systematic review.
        Crit Care. 2013; 17: R48
        • Clarke W.L.
        • Cox D.
        • Gonder-Frederick L.A.
        • Carter W.
        • Pohl S.L.
        Evaluating clinical accuracy of systems for self-monitoring of blood glucose.
        Diabetes Care. 1987; 10: 622-628
        • Nowotny B.
        • Nowotny P.J.
        • Strassburger K.
        • Roden M.
        Precision and accuracy of blood glucose measurements using three different instruments.
        Diabet Med. 2012; 29: 260-265
        • Chan A.Y.
        • Swaminathan R.
        • Cockram C.S.
        Effectiveness of sodium fluoride as a preservative of glucose in blood.
        Clin Chem. 1989; 35: 315-317
        • Macrae D.
        • Grieve R.
        • Allen E.
        • et al.
        • CHiP Investigators
        A randomized trial of hyperglycemic control in pediatric intensive care.
        N Engl J Med. 2014; 370 ([published correction appears in N Engl J Med. 2014;370(15):1469]): 107-118
        • NICE-SUGAR Study Investigators
        Hypoglycemia and risk of death in critically ill patients.
        N Engl J Med. 2012; 367: 1108-1118