請用此 Handle URI 來引用此文件: http://hdl.handle.net/11455/34751
標題: Assessing the quality of Bionime self-monitoring blood glucose system Rightest GM110: A critical evaluation of interference and ambient circumstances
作者: Hsu, C.T.
曾志明
Hsiao, H.C.
Lee, M.S.
Chang, S.F.
Lee, T.C.
Tsai, Y.S.
Zen, J.M.
關鍵字: Glucose meters
Interference
Ambient circumstances
Accuracy
clinical-evaluation
amperometric biosensor
accuracy
performance
meter
temperature
期刊/報告no:: Clinica Chimica Acta, Volume 402, Issue 1-2, Page(s) 119-123.
摘要: Background: The key issue in preventing chronic diabetic complications is to maintain near-normoglycemia. Analytical evaluation of Bionime self-monitoring blood glucose (SMBG) Rightest GM110 was carried out in this study. Methods: The evaluation was executed according to the Standards for Reporting Diagnostic Accuracy (STARD) and the Clinical and Laboratory Standards Institute (CLSI). The evaluation procedure mainly focused on analytical performance. The accuracy tests included hematocrit, interferants, temperature, humidity, altitude and clinical evaluations. Results: Good linearity response (R(2)>0.99) and satisfactory precision (CVs: 1.1-2.8%) were observed in glucose concentrations of 0.6-30.5 mmol/l. In hematocrit test, the Rightest GM110 was suitable for use in sample containing hernatocrit in the range of 30-55%. Interfering test indicated that almost all substances tested were insignificant, with bias +/- 10% in medium- and hyper-glycemia samples. Satisfactory stability was also found under various ambient circumstances, with bias within 10%. In clinical trials, values within the acceptable zone (A+B) were 100% and values within zone A exceed 95% in error grid analysis. Conclusions: The Bionime Rightest GM110 is reliable to display accurate glucose concentrations in specimens with irresistible interfering factors. (C) 2009 Elsevier B.V. All rights reserved.
URI: http://hdl.handle.net/11455/34751
ISSN: 0009-8981
文章連結: http://dx.doi.org/10.1016/j.cca.2008.12.029
顯示於類別:化學系所

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