Assessing the quality of Bionime self-monitoring blood glucose system Rightest GM110: A critical evaluation of interference and ambient circumstances

Clinica Chimica Acta

Volumn 402, Issue 1-2, 2009, Pages 119-123

  Hsu, Cheng Teng ^a   Hsiao, Hung Chan ^a   Lee, Ming Shih ^b,c   Chang, Shuo Fen ^a   Lee, Tsung Chien ^a   Tsai, Yang Sheng ^b   Zen, Jyh Myng ^d  

^a Department of Core Technical Research   (Taiwan)

^b CHUNG SHAN MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^c CHUNG SHAN MEDICAL UNIVERSITY   (Taiwan)

^d NATIONAL CHUNG HSING UNIVERSITY   (Taiwan)

Author keywords

Accuracy; Ambient circumstances; Glucose meters; Interference

Indexed keywords

GLUCOSE;

ALTITUDE; ANALYTIC METHOD; ARTICLE; DEVICE; EVALUATION; GLUCOSE BLOOD LEVEL; HEMATOCRIT; HUMAN; HUMIDITY; PRIORITY JOURNAL; QUALITY CONTROL; RELIABILITY; TEMPERATURE;

ADULT; AGED; AGED, 80 AND OVER; BLOOD GLUCOSE; BLOOD GLUCOSE SELF-MONITORING; DIABETES COMPLICATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; QUALITY CONTROL; YOUNG ADULT;

EID: 60649086908     PISSN: 00098981     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cca.2008.12.029     Document Type: Article

References (38)

1. Standards of medical care in diabetes. Diabetes Care 29 (2006) S4-S42
2. Gutman S., Bernhardt P., Pinkos A., Moxey-Mims M., Knott T., and Cooper J. Regulatory aspects of invasive glucose measurements. Diabetes Technol Ther 4 (2002) 775-777
3. Mahoney J., and Ellison J. Assessing the quality of glucose monitor studies: a critical evaluation of published reports. Clin Chem 53 (2007) 1122-1128
4. Nichols J.H. Interpreting method evaluations. Diabetes Technol Ther 4 (2002) 623-625
5. Chen E.T., Nichols J.H., Duh S.H., and Hortin G. Performance evaluation of blood glucose monitoring devices. Diabetes Technol Ther 5 (2003) 749-768
6. Nichols J.H. What is accuracy and how close must the agreement be?. Diabetes Technol Ther 7 (2005) 558-562
7. Arabadjief D., and Nichols J.H. Assessing glucose meter accuracy. Curr Med Res Opin 22 (2006) 2167-2174
8. Martin D.D., Shephard M.D., Freeman H., Bulsara M.K., Jones T.W., et al. Point-of-care testing of HbA1c and blood glucose in a remote Aboriginal Australian community. Med J Aust 182 (2005) 524-527
9. Finkielman J.D., Oyen L.J., and Afessa B. Agreement between bedside blood and plasma glucose measurement in the ICU setting. Chest 127 (2005) 1749-1751
10. Miendje Deyi V.Y., Philippe M., Alexandre K.C., De Nayer P., and Hermans M.P. Performance evaluation of the Precision PCx point-of-care blood glucose analyzer using discriminant ratio methodology. Clin Chem Lab Med 40 (2002) 1052-1055
11. The Diabetes Research in Children Network Study Group. A multicenter study of the accuracy of the One Touch Ultra home glucose meter in children with type 1 diabetes. Diabetes Technol Ther 5 (2003) 933-941
12. Krouwer J.S. How to improve total error modeling by accounting for error sources beyond imprecision and bias. Clin Chem 47 (2001) 1329-1331
13. Papp M., and Sharief N. Comparison of two strip test methods of whole blood glucose measurement in the neonatal period. Acta Paediatr 90 (2001) 1042-1046
14. Tang Z., Lee J.H., Louie R.F., and Kost G.J. Effects of different hematocrit levels on glucose measurements with handheld meters for point-of-care testing. Arch Pathol Lab Med 124 (2000) 1135-1140
15. Schleis T.G. Interference of maltose, icodextrin, galactose, or xylose with some blood glucose monitoring systems. Pharmacotherapy 27 (2007) 1313-1321
16. Husoy A.M., Knudsen G.R., Thierley M., and Svarstad E. False measurement of glucose during dialysis with icodextrin. Tidsskr Nor Laegeforen 126 (2006) 2268-2270
17. Haller M.J., Shuster J.J., Schatz D., and Melker R.J. Adverse impact of temperature and humidity on blood glucose monitoring reliability: a pilot study. Diabetes Technol Ther 9 (2007) 1-9
18. Nawawi H., Sazali B.S., Kamaruzaman B.H., Yazid T.N., Jemain A.A., et al. Effect of ambient temperature on analytical and clinical performance of a blood glucose monitoring system: Omnitest Sensor glucose meter. Ann Clin Biochem 38 (2001) 676-683
19. Wu M.H., Fang M.Y., Jen L.N., Hsiao H.C., Muller A., and Hsu C.T. Clinical evaluation of Bionime Rightest GM310 biosensors with a simplified electrode fabrication for alternative-site blood glucose tests. Clin Chem 54 (2008) 1689-1695
20. Hsu C.T., Chung H.H., Tsai D.M., Fang M.Y., Hsiao H.C., and Zen J.M. Fabrication of a glucose biosensor based on inserted barrel plating gold electrodes. Anal Chem (2008) (ASAP)
21. Mahoney J.J., and Ellison J.M. Assessing glucose monitor performance-a standardized approach. Diabetes Technol Ther 9 (2007) 545-552
22. Bossuyt P.M., Reitsma J.B., Bruns D.E., Gatsonis C.A., Glasziou P.P., Irwig L.M., et al. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Standards for Reporting of Diagnostic Accuracy. Clin Chem 49 (2003) 1-6
23. CLSI. . Point-of-care blood glucose testing in acute and chronic care facilities; approved guideline - second edition. CLSI document C30-A2 (2002), CLSI. 1-56238-471-6
24. CLSI. . Method comparison and bias estimation using patient samples; approved guideline-second edition. CLSI document EP9-A2 (2002), CLSI. 1-56238-472-4
25. CLSI. . Interference testing in clinical chemistry; approved guideline-second edition. CLSI document EP7-A2 (2005), CLSI. 1-56238-584-4
26. Food and Drug Administration. Total product life cycle for portable invasive blood glucose monitoring systems (draft guidance for industry and FDA staff) (2006), Center for Devices and Radiological Health, Food and Drug Administration, U S Department of Health and Human Services, Rockville, MD
27. International Organization for Standardization. In-vitro diagnostic test systems-requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197. Geneva, Switzerland (2003) ISO 15197
28. Clarke W.L., Cox D., Gonder-Frederick L.A., Carter W., and Pohl S.L. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care 10 (1987) 622-6228
29. Chen H.S., Kuo B.I., Hwu C.M., Shih K.C., Kwok C.F., and Ho L.T. Technical and clinical evaluation of an electrochemistry glucose meter: experience in a diabetes center. Diabetes Res Clin Pract 42 (1998) 9-15
30. Demir S., Yilmazturk G.C., and Aslan D. Technical and clinical evaluation of a glucose meter employing amperometric biosensor technology. Diabetes Res Clin Pract 79 (2008) 400-404
31. Lee C.H., Wang S.C., Yuan C.J., Wen M.F., and Chang K.S. Comparison of amperometric biosensors fabricated by palladium sputtering, palladium electrodeposition and Nafion/carbon nanotube casting on screen-printed carbon electrodes. Biosens Bioelectron 22 (2007) 877-884
32. Crouch E., Cowell D.C., Hoskins S., Pittson R.W., and Hart J.P. A novel, disposable, screen-printed amperometric biosensor for glucose in serum fabricated using a water-based carbon ink. Biosens Bioelectron 21 (2005) 712-718
33. Tests of glycemia in diabetes. Diabetes Care 23 Suppl 1 (2000) S80-S82
34. Tate P.F., Clements C.A., and Walters J.E. Accuracy of home blood glucose monitors. Diabetes Care 15 (1992) 536-538
35. American Diabetes Association: clinical practice recommendations 1996. Diabetes Care 19 Suppl 1 (1996) S1-S118
36. Sacks D.B., Bruns D.E., Goldstein D.E., Maclaren N.K., McDonald J.M., and Parrott M. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 48 (2002) 436-472
37. Skeie S., Thue G., and Sandberg S. Patient-derived quality specifications for instruments used in self-monitoring of blood glucose. Clin Chem 47 (2001) 67-73
38. Chan J.C., Wong R.Y., Cheung C.K., Lam P., Chow C.C., Yeung V.T., et al. Accuracy, precision and user-acceptability of self blood glucose monitoring machines. Diabetes Res Clin Pract 36 (1997) 91-104