Accuracy and Precision in "Class A" and "Class B" Blood Glucose Meters

作者：Schipper C^*; Musholt P B; Ramljak S; Knesovic M; Borchert M; Forst T; Pfuetzner A

来源：Diabetes, Stoffwechsel und Herz, 2012, 21(3): 151-155.

• blood glucose meters
• low cost meters
• accuracy
• precision

The aim of this study was to evaluate accuracy and intra-assay precision in low-cost blood glucose meters with electrochemical sensors compared to BG*Star and iBG*Star. Blood samples were drawn from five patients with varying blood glucose concentrations (50-400 mg/dl). The samples were tested ten times with ten devices from each type. Devices tested were: GlucoCheck Comfort, GlucoTest TD, FineTouch, BeurerGL40, MediTouch, OmniTest3, MyLife GM300, IME iDia, GlucoCheck plus, BG*Star and iBG*Star. Mean intra-assay CV/MARD results were as follows: BG*Star 5.61 %/6.43 %, iBG*Star 5.24 %/3.48 %, GlucoCheck Comfort 5.62 %/11.24 %, GlucoTest TD 4.49 %/13.10 %, FineTouch 6.10 %/8.67 %, Beurer GL40 3.86 %/10.60 %, MediTouch 4.16 %/1746 %, OmniTest3 7.45 %/20.93 %, MyLife GM300 3.70 %/12.23%, IME iDia 6.55 %/22.92%, GlucoCheck plus 5.32 %/16.50%. BG*Star and iBG*Star were significantly more accurate than any other device (p < 0.001 vs. all other meters). With few exceptions, intra-assay, precision was comparable between the devices, ranging between 3 % and 6% in most cases. This laboratory study demonstrates that BG*Star and iBG*Star are more accurate than low-cost meters., CV was similar in across the devices, indicating that intra-assay precision may not present a quality issue in low-cost meter technologies.

• 出版日期2012-6-20