title: Technical and clinical evaluation of an electrochemistry glucose meter: experience in a diabetes center.
abstract: The Sensorex (Metertech, Taipei, Taiwan), an electrochemical blood glucose meter, is designed for self-monitoring of blood glucose (BG) concentrations in capillary blood through the use of an electrochemical test strip. The intra-assay coefficients of variation of Sensorex were 5.2, 5.4, and 4.7% at BG levels of 46, 154 and 302 mg/dl respectively. The BG concentrations tested by Sensorex were correlated well with those by YSI method (r approximately/= 0.85, P < 0.0001). The intraclass correlation coefficients (rI) between the results obtained by Sensorex and YSI were 0.84 in capillary blood and 0.69 in venous whole blood, which indicated good agreement between both methods. The Sensorex was evaluated by error grid analysis and revealed 'acceptance' results. In field test, the Sensorex results obtained by lay users were in concordance with those by trained technicians (rI = 0.87). Our data show that the Sensorex glucometer is reliable and easy to use. We also demonstrate a practical clinical approach for the evaluation of a novel SMBG system.
authors.affiliation: Department of Medicine, Veterans General Hospital-Taipei, Taiwan, ROC.
authors.forename: H S
authors.initials: HS
authors.lastname: Chen
authors.forename: B I
authors.initials: BI
authors.lastname: Kuo
authors.forename: C M
authors.initials: CM
authors.lastname: Hwu
authors.forename: K C
authors.initials: KC
authors.lastname: Shih
authors.forename: C F
authors.initials: CF
authors.lastname: Kwok
authors.forename: L T
authors.initials: LT
authors.lastname: Ho
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000379:methods; D002196:Capillaries; D003920:Diabetes Mellitus / Q000097:blood*; D004563:Electrochemistry / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011934:Reagent Strips; D012044:Regression Analysis; D015203:Reproducibility of Results; D014680:Veins
chemical_list: D001786:Blood Glucose; D011934:Reagent Strips