Variability of point-of-care testing blood glucometers versus the laboratory reference method in a tertiary teaching hospital

1. Burtis CA, Ashwood ER, Bruns DE, editors. Tietz textbook of clinical chemistry and molecular diagnostics. 4th ed. St Louis Missouri USA: Elsevier Saunders; 2006.Search in Google Scholar

2. Tonyushkina K, Nichols JH. Glucose Meters: A review of technical challenges to obtaining accurate results. J Diabetes Sci Technol. 2009; 3:971-8010.1177/193229680900300446Search in Google Scholar

3. D’Orazio P, Burnett RW, Fogh-Andersen N, Jacobs E, Kuwa K, Külpmann WR, Larsson L, et al. Approved IFCC recommendation on reporting results for blood glucose. Clin Chem. 2005; 51:1573-6.10.1373/clinchem.2005.051979Search in Google Scholar

4. International Organization for Standardization. In vitro diagnostic test systems-requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus. ISO/TC 212/SC. Final draft International Standard ISO/FDIS 15197. Geneva, Switzerland, 2003.Search in Google Scholar

5. DCCT. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin dependent diabetes mellitus. NEJM. 1993; 329:977-86.10.1056/NEJM199309303291401Search in Google Scholar

6. UK Prospective Diabetes Study (UKPDS) group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998; 352:837-53.10.1016/S0140-6736(98)07019-6Search in Google Scholar

7. Draft guidance for industry and FDA staff-total product life cycle for portable invasive blood glucose monitoring systems. [Internet]. [cited 2010 Nov 29].Available from http://www.fda.gov/cdrh/oivd/guidance/1603.htmlSearch in Google Scholar

8. Clarke WL, Cox D, Gonder-Frederick LA, et al. Evaluating clinical accuracy of systems for self monitoring of blood glucose. Diabetes Care. 1987; 10: 622-8.10.2337/diacare.10.5.6223677983Search in Google Scholar

9. Kost GJ. Louie R. Veerasamy N. Aleman K. Tran NK. Tang Z. Meeting the challenge of the International Standard ISO 15197 for capillary glucose accuracy. Clin Chem. 2005; 51:A255.Search in Google Scholar

10. Tang Z, Lee JH, Louie RF, Kost GJ. Effects of different hematocrit levels on glucose measurements with handheld meters for point-of-care testing. Arch Pathol Lab Med. 2000; 124:1135-40.10.5858/2000-124-1135-EODHLO10923072Search in Google Scholar

11. Louie RF, Tang Z, Sutton DV, Lee JH, Kost GJ. Point of- care glucose testing: effects of critical care variables influence of reference instruments, and a modular glucose meter design. Arch Pathol Lab Med. 2000; 124:257-66.10.5858/2000-124-0257-POCGT10656736Search in Google Scholar

12. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986; 1:307-10.Search in Google Scholar

13. Khan AI, Vasquez Y, Gray J, Wians FH Jr, Kroll MH. The variability of results between point-of-care testing glucose meters and the central laboratory analyzer. Arch Pathol Lab Med. 2006; 130:15-32.10.5858/2006-130-1527-TVORBP17090196Search in Google Scholar

14. Kost GJ. Understanding and preventing medical errors in point-of-care testing (and the use of FAST-QC). In: Nichols JH, editor. Point-of-care testing: performance improvement and evidence-based outcomes. Chapter 4. New York: Marcel Dekker; 2003.10.1201/b14092-5Search in Google Scholar

15. Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL. Evaluation of clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987; 5:62210.2337/diacare.10.5.622Search in Google Scholar