Clinical evaluation of the eBsensor hand-held blood glucose monitoring system.

BACKGROUND: Home glucose monitoring system is increasingly recognized as an important tool for glycemic control. We evaluated the clinical performance of the eBsensor glucose monitoring system. METHODS: Fingertip capillary blood glucose concentrations from 282 subjects were measured using eBsensor glucose monitoring system and compared against predicate devices and the Yellow Springs Instruments (YSI) 2300 blood glucose analyzer. Accuracy and precision of the eBsensor glucose monitoring system were assessed using several methods. The comparative study between the eBsensor and 2 currently marketed monitoring systems was performed. RESULTS: The 282 eBsensor readings covered a wide range from 2.6 to 24.4 mmol/l. Deming regression and Pearson correlation analyses showed a linear relationship between the eBsensor readings and the YSI reference method (eBsensor=0.9496 YSI+0.4127 mmol/l; r=0.98). Error Grid analysis demonstrated that 100% of the eBsensor readings in clinically acceptable zones A and B. The CVs for the 6 lots of strips were within the satisfactory interval (<6%). The comparative study showed that the eBsensor readings correlated well with the OneTouch Ultra values (r=0.97) and the Glucocard II values (r=0.97). CONCLUSIONS: eBsensor is a reliable glucose monitoring system which provides high accurate and precise glucose readings over a wide range of glucose concentrations.

An evaluation of clinical accuracy of the EasyTouch blood uric acid self-monitoring system.

OBJECTIVES: Self-monitoring blood uric acid device is an important tool for patients to efficiently monitor their blood uric acid concentrations. The objective of the present study was to evaluate the accuracy of EasyTouch uric acid monitoring system. DESIGN AND METHODS: Capillary blood uric acid concentrations measured using EasyTouch and the reference values obtained from COBAS MIRA were performed in the Department of Laboratory Medicine, Wei-Gong Memorial Hospital. Results were evaluated using (1) linear regression analysis, (2) percentage of readings within a defined range of deviation from the reference value, and (3) coefficients of variation (CVs) calculated from 60 measurements in series. RESULTS: The window of the 177 EasyTouch readings covered a wide range from 0.1785 to 0.6367 mmol/L (3-10.7 mg/dL). Linear regression analysis yielded a regression slope of 0.975, an intercept of 0.0118 mmol/L and an R2 of 0.8966. Of the EasyTouch readings, 64 (36.2%), 61 (34.5%), 34 (19.2%), 9 (5.08%), and 9 (5.08%) were within the intervals of <5%, 5-10%, 10-15%, 15-17%, and >17%, respectively, of the reference values. Further analysis for the performance of each lot of strips showed that both coefficients of correlation and the percentages of readings within the CLIA's criterion (+/-17%), respectively, were in a narrow range from 0.8777 to 0.9541 and from 92.1% to 100%. The CVs for the seven lots of strips (lot 1 to lot 7) ranged from 2.93% to 6.33%, 3.2% to 5.9%, 3.64% to 7.0%, 2.84% to 7.6%, 2.68% to 5.42%, 3.03% to 6.93%, and 3.18% to 5.17%, respectively. CONCLUSION: EasyTouch is an acceptable diagnostic device which provides accurate uric acid measurements.

Accuracy of the EasyTouch blood glucose self-monitoring system: a study of 516 cases.

BACKGROUND: Self-monitoring blood glucose device is an important tool for diabetes patients to efficiently control their blood glucose concentrations. We evaluated the accuracy of EasyTouch glucose monitoring system. METHODS: Capillary blood glucose concentrations measured using EasyTouch and the reference values obtained from Yellow Springs Instruments (YSI) 2300 STAT were performed in the Department of Laboratory Medicine, Wei-Gong Memorial Hospital. Results were evaluated using (1) linear regression analysis, (2) Clarke Error Grid analysis, (3) percentage of readings within a defined range of deviation from the reference value, (4) bias plots, and (5) coefficients of variation (CVs) calculated from 60 measurements in series. RESULTS: The window of the 516 EasyTouch readings covered a range from 42 to 555 mg/dl. Linear regression analysis yielded a regression slope 0.9972, intercept 1.899 mg/dl, r2 0.9571, and Syx 14.89 mg/dl. A Clarke Error Grid analysis showed 100% of the EasyTouch readings in clinically acceptable zones A and B. Of the EasyTouch readings, 98.3%, 91.9%, 78.3% and 46.9% were found within +/-20%, +/-15%, +/-10%, and +/-5%, respectively, of the reference values. Further analysis showed that the percentage of EasyTouch readings within the defined intervals was similar in three glucose ranges (< or =100, 101-200, and > or =201 mg/dl). The CVs for the four lots of strips (lot 1 to lot 4) ranged from 3.5 to 5.5%, 2.1 to 4.8%, 1.8 to 3.6%, and 3.0 to 5.7%, respectively. CONCLUSIONS: EasyTouch provides high accurate and precise glucose readings over a wide range of glucose concentrations.

E207K mutation of low-density lipoprotein receptor in familial hypercholesterolemia.

We report a case of heterozygous familial hypercholesterolemia (HeFH) in a 36-year-old man with premature coronary artery disease (CAD). Hypercholesterolemia was found in family members including his mother, wife and all 3 of his children (2 boys aged 6 and 3 years, 1 girl aged 4 years). Genetic analysis revealed a G-->A substitution at nucleotide 682, resulting in Glu(207) to Lys (E207K) mutation of the ligand-binding domain of the low-density lipoprotein receptor (LDLR) of all the family members with hypercholesterolemia except for the proband's wife. Genetic study showed that this mutation was inherited from the proband's mother then transmitted to all 3 children. Detection of this mutation identifies the cause of hypercholesterolemia and allows appropriate early treatment to prevent premature CAD.

Identification and characterization of LDL receptor gene mutations in hyperlipidemic Chinese.

DNA screening for LDL receptor mutations was performed in 170 unrelated hyperlipidemic Chinese patients and two clinically diagnosed familial hypercholesterolemia patients. Two deletions (Del e3-5 and Del e6-8), eight point mutations (W-18X, D69N, R94H, E207K, C308Y, I402T, A410T, and A696G), and two polymorphisms (A370T and I602V) were identified. Of these mutations, C308Y and Del e6-8 were found in homozygosity, and D69N and C308Y were seen in unrelated patients. The effects of mutations on LDL receptor function were characterized in COS-7 cells. The LDL receptor level and activity were close to those of wild type in A696G transfected cells. A novel intermediate protein and reduction of LDL receptor activity were seen in D69N transfected cells. For R94H, E207K, C308Y, I402T, and A410T mutations, only approximately 20-64% of normal receptor activities were seen. Conversely, Del e3-5 and Del e6-8 lead to defective proteins with approximately 0-13% activity. Most of the mutant receptors were localized intracellularly, with a staining pattern resembling that of the endoplasmic reticulum and Golgi apparatus (D69N, R94H, E207K, C308Y, and I402T) or endosome/lysosome (A410T and Del e6-8). Molecular analysis of the LDL receptor gene will clearly identify the cause of the patient's hyperlipidemia and allow appropriate early treatment as well as antenatal and family studies.