Assessing the quality of Bionime self-monitoring blood glucose system Rightest GM110: a critical evaluation of interference and ambient circumstances.
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 hematocrit 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.
Hsu
Cheng-Teng
CT
Department of Core Technical Research, Bionime Corporation, Taichung 412, Taiwan. brown.hsu@bionime.com
Hsiao
Hung-Chan
HC
Lee
Ming-Shih
MS
Chang
Shuo-Fen
SF
Lee
Tsung-Chien
TC
Tsai
Yang-Sheng
YS
Zen
Jyh-Myng
JM
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards*; D048909:Diabetes Complications / Q000175:diagnosis* / Q000517:prevention & control; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011786:Quality Control; D055815:Young Adult
D001786:Blood Glucose