Evaluation of point-of-care glucose testing accuracy using locally-smoothed median absolute difference curves

Clinica Chimica Acta

Volumn 389, Issue 1-2, 2008, Pages 31-39

  Kost, Gerald J ^a   Tran, Nam K ^a   Abad, Victor J ^b   Louie, Richard F ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b Epsilon Group   (United States)

Author keywords

Bandwidth; Bland Altman; Bracket predictive value; Error tolerance; ISO 15197; Tight glucose control (TGC)

Indexed keywords

GLUCOSE;

ADULT; ARTICLE; BLOOD GAS ANALYSIS; BLOOD SAMPLING; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; GLUCOSE TOLERANCE TEST; GLYCEMIC CONTROL; HUMAN; HUMAN CELL; HUMAN EXPERIMENT; NORMAL HUMAN; POINT OF CARE TESTING; PRIORITY JOURNAL;

BLOOD GLUCOSE; HEMATOCRIT; HUMANS; OXYGEN; POINT-OF-CARE SYSTEMS; REFERENCE STANDARDS;

EID: 38649115012     PISSN: 00098981     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cca.2007.11.019     Document Type: Article

References (26)

1. Tran N.K., Promptmas C., and Kost G.J. Biosensors, miniaturization, and noninvasive techniques. In: Ward Cook K.M., Lehman C.A., Schoeff L.E., et al. (Eds). Clinical Diagnostic Technology: The Total Testing Process. The Postanalytical Phase volume 3 (2006), American Association for Clinical Chemistry Press, Washington D.C. 145-184 Chapter 7
2. Clarke W.L., Cox D., Gonder-Frederick L.A., et al. Evaluating clinical accuracy of systems for self monitoring of blood glucose. Diabetes Care 10 (1987) 622-628
3. Bland J.M., and Altman D.G. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1 (1986) 307-310
4. International Organization for Standardization. Vitro Diagnostic Test Systems-Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus. International Standard (2003), International Organization for Standardization, Geneva Report Number ISO 15197:2003(E)
5. Kost G.J., Louie R., Veerasamy N., et al. Meeting the challenge of the International Standard ISO 15197 for capillary glucose accuracy. Clin Chem 51 (2005) A255 [abstract]
6. Draft guidance for industry and FDA staff-total product life cycle for portable invasive blood glucose monitoring systems. FDA website: http://www.fda.gov/cdrh/oivd/guidance/1603.html. Accessed on July 30, 2007.
7. Kost G.J., Vu H.T., Lee J.H., et al. Multicenter study of oxygen-insensitive handheld glucose point-of-care testing in critical care/hospital/ambulatory patients in the United States and Canada. Crit Care Med 26 (1998) 581-590
8. Lazar H.L., Chipkin S.R., Fitzgerald C.A., et al. Tight glycemic control in diabetic coronary artery bypass graft improves perioperative outcomes and decreases recurrent ischemic events. Circulation 109 (2004) 1497-1502
9. Zimmerman C.R., Mlynarek M.E., Jordan J.A., et al. An insulin infusion protocol in critically ill cardiothoracic surgery patients. Ann Pharmacother 38 (2004) 1123-1129
10. Krinsley J.S. Association between hyperglycemia and increased hospital mortality in a heterogeneous population of critically ill patients. Mayo Clin Proc 78 (2003) 1471-1478
11. Goldberg P.A., Siegel M.D., Sherwin R.S., et al. Implementation of a safe and effective insulin infusion protocol in a medical intensive care unit. Diabetes Care 27 (2004) 461-467
12. Meynaar I.A., Dawson L., Tangkau P.L., et al. Introduction and evaluation of a computerized insulin protocol. Intensive Care Med 33 (2007) 591-596
13. Carr J.M., Sellke F.W., Fey M., et al. Implementing tight glucose control after coronary artery bypass surgery. Ann Thorac Surg 80 (2005) 902-909
14. Pham T.N., Warren A.J., Phan H.H., et al. Impact of tight glycemic control in severely burned children. J Trauma 59 (2005) 1148-1154
15. Plank J., Blaha J., Cordingley J., et al. Multicentric, randomized, controlled trial to evaluate blood glucose control by the model predictive control algorithm versus routine glucose management protocols in intensive care unit patients. Diabetes Care 29 (2006) 271-276
16. Van den Berghe G., Wouters P., Weekers F., et al. Intensive insulin therapy in critically ill patients. N Eng J Med 345 (2001) 1359-1367
17. Van den Berghe G., Wouters P.J., Bouillon R., et al. Outcome benefit of intensive insulin therapy in the critically ill: insulin dose versus glycemic control. Crit Care Med 31 (2003) 359-366
18. Van den Berghe G., Woulters P.J., Kesteloot K., et al. Analysis of healthcare resource utilization with intensive insulin therapy in critically ill patients. Crit Care Med 34 (2006) 612-616
19. Khan A.I., Vasquez Y., Gray J., et al. The variability of results between point-of-care testing glucose meters and the central laboratory analyzer. Arch Pathol Lab Med 130 (2006) 1527-1532
20. Louie R.F., Tang Z., Sutton D.V., et al. Point-of-care glucose testing: effects of critical care variables, influence of reference instruments, and a modular glucose meter design. Arch Pathol Lab Med 124 (2000) 257-266
21. Tang Z., Lee J.H., Louie R.F., et al. Effects of different hematocrit levels on glucose measurements with handheld meters for point-of-care testing. Arch Pathol Lab Med 124 (2000) 1135-1140
22. Tang Z., Louie R.F., Lee J.H., et al. Oxygen effects on glucose meter measurements with glucose dehydrogenase- and oxidase-based test strips for point-of-care testing. Crit Care Med 29 (2001) 1062-1070
23. Parkes J.L., Slatin S.L., Pardo S., et al. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care 23 (2000) 1143-1148
24. Krouwer J.S., and Monti K.L. A simple, graphical method to evaluate laboratory assays. Eur J Clin Chem Clin Biochem 33 (1995) 525-527
25. Kost G.J. Understanding and preventing medical errors in point-of-care testing (and the use of FAST-QC). In: Nichols J.H. (Ed). Point-of-Care Testing: Performance Improvement and Evidence-Based Outcomes (2003), Marcel Dekker, New York 101-120 Chapter 4
26. Kost G.J. The hybrid laboratory, therapeutic turnaround time, critical limits, performance maps, and Knowledge Optimization®. In: Kost G.J. (Ed). Principles and Practice of Point-of-Care Testing (2002), Lippincott Williams and Wilkins, Philadelphia 13-25 Chapter 2