Is Estimation Of Blood Glucose By Glucometer More Reliable Than Laboratory Analysis? A Comparative Study Done At Rural Hospital Of Maharashtra

Introduction: Diabetes is a major public health problem that is approaching epidemic propor?ons globally. Selfmonitoring of blood glucose (SMBG) by the American Diabetes Associa?on (ADA) is promoted in diabe?c pa?ents so that they achieve and maintain specific glycemic goals. Objec?ves : To compare the blood glucose es?ma?on methods; capillary blood and venous blood by glucometer, venous plasma glucose es?ma?on by auto analyzer and to find varia?on in results. Material & Methods : 60 pa?ents a?ending Outpa?ent department of JIIUs IIMSR and Noor hospital, Warudi, Badnapur, Maharashtra who were advised blood glucose es?ma?on were selected. Finger prick (capillary) blood glucose & glucose es?ma?on of venous blood was done by glucometer; and venous plasma glucose es?ma?on was done by auto analyzer in laboratory. Result & Conclusion : Mean values of capillary glucose es?ma?on by glucometer were higher than plasma glucose es?ma?on in laboratory on auto analyzer and the difference was found to be sta?s?cally significant. Venous glucose es?ma?on on glucometer gave high erroneous results as compared to plasma glucose es?ma?on in laboratory.

Gingival Crevicular Blood in the Diagnosis of Blood Glucose Level

Introduction: The etiopathogenesis of diabetes mellitus ismulti-factorial & complex and appears to involve interactionsof various immunological, genetic and environmental factors1.The Diabetes mellitus is associated with increased bloodglucose level. It represent one of the major chronic healthproblem faced by the society today2. The aim of this study isto evaluate a quick, safe, noninvasive and painless method toscreen for diabetes during regular clinical examination usingself-monitoring glucometer.Material and Methods: 35 cases who were reported toPrimary health centre, sahdei buzurg for hematologicalexamination were selected for the study. Probing of gingivalsulcus was done using William’s WHO probe. Blood oozingfrom the sulcus was collected on the strip provided by theglucometer and blood glucose level was recorded. For control,finger prick capillary blood was collected and blood glucoselevel was analyzed. Statistical analysis was done usingPearson’s Correlation Coefficient.Result: The result revealed strong correlation betweengingival crevicular blood and peripheral capillary measuredblood glucose level.Conclusion: Gingival crevicular blood collected duringclinical examination may be an excellent painless source ofblood for glucometric analysis.

A simplified and miniaturized glucometer-based assay for the detection of β-glucosidase activity / 浙江大学学报（英文版）（B辑：生物医学和生物技术）

β-Glucosidase activity assays constitute an important indicator for the early diagnosis of neonatal necrotizing enterocolitis and qualitative changes in medicinal plants. The drawbacks of the existing methods are high consumption of both time and reagents, complexity in operation, and requirement of expensive instruments and highly trained personnel. The present study provides a simplified, highly selective, and miniaturized glucometer-based strategy for the detection of β-glucosidase activity. Single-factor experiments showed that optimum β-glucosidase activity was exhibited at 50 °C and pH 5.0 in a citric acid-sodium citrate buffer when reacting with 0.03 g/mL salicin for 30 min. The procedure for detection was simplified without the need of a chromogenic reaction. Validation of the analytical method demonstrated that the accuracy, precision, repeatability, stability, and durability were good. The linear ranges of β-glucosidase in a buffer solution and rat serum were 0.0873-1.5498 U/mL and 0.4076-2.9019 U/mL, respectively. The proposed method was free from interference from β-dextranase, snailase, β-galactosidase, hemicellulase, and glucuronic acid released by baicalin. This demonstrated that the proposed assay had a higher selectivity than the conventional dinitrosalicylic acid (DNS) assay because of the specificity for salicin and unique recognition of glucose by a personal glucose meter. Miniaturization of the method resulted in a microassay for β-glucosidase activity. The easy-to-operate method was successfully used to detect a series of β-glucosidases extracted from bitter almonds and cultured by Aspergillus niger. In addition, the simplified and miniaturized glucometer-based assay has potential application in the point-of-care testing of β-glucosidase in many fields, including medical diagnostics, food safety, and environmental monitoring.

A simplified and miniaturized glucometer-based assay for the detection of β-glucosidase activity / 浙江大学学报（英文版）（B辑：生物医学和生物技术）

β-Glucosidase activity assays constitute an important indicator for the early diagnosis of neonatal necrotizing enterocolitis and qualitative changes in medicinal plants. The drawbacks of the existing methods are high consumption of both time and reagents, complexity in operation, and requirement of expensive instruments and highly trained personnel. The present study provides a simplified, highly selective, and miniaturized glucometer-based strategy for the detection of β-glucosidase activity. Single-factor experiments showed that optimum β-glucosidase activity was exhibited at 50 °C and pH 5.0 in a citric acid-sodium citrate buffer when reacting with 0.03 g/mL salicin for 30 min. The procedure for detection was simplified without the need of a chromogenic reaction. Validation of the analytical method demonstrated that the accuracy, precision, repeatability, stability, and durability were good. The linear ranges of β-glucosidase in a buffer solution and rat serum were 0.0873–1.5498 U/mL and 0.4076–2.9019 U/mL, respectively. The proposed method was free from interference from β-dextranase, snailase, β-galactosidase, hemicellulase, and glucuronic acid released by baicalin. This demonstrated that the proposed assay had a higher selectivity than the conventional dinitrosalicylic acid (DNS) assay because of the specificity for salicin and unique recognition of glucose by a personal glucose meter. Miniaturization of the method resulted in a microassay for β-glucosidase activity. The easy-to-operate method was successfully used to detect a series of β-glucosidases extracted from bitter almonds and cultured by Aspergillus niger. In addition, the simplified and miniaturized glucometer-based assay has potential application in the point-of-care testing of β-glucosidase in many fields, including medical diagnostics, food safety, and environmental monitoring.

Performance Evaluation of Glucometer Barozen H Based on ISO 15197 Standards

BACKGROUND: We have evaluated the analytical performance of Barozen H (i-SENS Inc. Seoul, Korea), which was developed for glucose testing and can be connected to hospital information network systems. METHODS: We evaluated the precision of ten glucometers based on repeatability and intermediate precision according to the guidelines of the International Standardization Organization (ISO) 15197:2011. The linearity of patient samples was in the range of 30.7-551.2 mg/dL. The accuracy of the results of Barozen H and the correlation of these results and those of the two other glucometers in comparisons with the Modular D reference device (Roche Diagnostics Ltd., Switzerland) were evaluated using 150 capillary blood and venous whole blood samples. RESULTS: The ranges for the repeatability and intermediate precision of ten Barozen H glucometers were 1.58-4.61% and 2.85-5.48%, respectively. The linearity was expressed by y=0.9681x+2.0791, and the coefficient of determination (R2) was 0.9996. When venous whole blood samples were used, the correlation coefficient (r) was 0.9914. When glucose levels were under 100 mg/dL, 95.2% of Barozen H results were within +/-15 mg/dL, and when glucose levels were 100 mg/dL or higher, 97.2% were within +/-15%. When capillary blood samples were used, 41.4% (under 100 mg/dL) and 55.4% (100 mg/dL or higher) of Barozen H results were within +/-15 mg/dL and +/-15%, respectively. CONCLUSIONS: Barozen H provided reliable results and satisfied the ISO15197:2011 criteria when venous whole blood samples were used. It is thought to be clinically useful as a hospital point-of-care glucometer.

Evaluación de la glucemia a través de dos métodos analíticos en la atención de urgencia / Assessment of Blood Glucose Levels by Two Analytic Methods in the Emergency Room

Introducción: la medición de un mismo parámetro en Medicina por diferentes métodos exige comprobaciones de concordancia entre estos. Objetivo: determinar el desacuerdo, entre la glucemia obtenida mediante un glucómetro y el método habitual de laboratorio en pacientes atendidos en Cuerpo de Guardia. Métodos: estudio observacional descriptivo de serie de casos en pacientes que acudieron a Cuerpo de Guardia del Hospital Vladimir Ilich Lenin de Holguín, Cuba, durante marzo de 2013, que requirieron determinación de glucemia. El tamaño muestral se calculó sobre la base del 5 % de desacuerdo esperado por las normas de la International Organization for Standardization (ISO 15197:2003), resultaron 72 pacientes a los cuales se les aplicó además muestreo aleatorio simple y criterios de exclusión. La glucemia se determinó mediante el método de referencia (RapiglucoTest) y el glucómetro SUMASENSOR SXT. Resultados: los pacientes tenían 58,7 ± 18,3 años; 54,2 % eran mujeres; 51,4 % diabéticos y el 70,8 % no estaban en ayunas. El error medio absoluto fue 9,5 ± 8,07 %. El desacuerdo entre métodos fue del 4,8 %. El sesgo y la precisión fueron 0,40 mmol/L y ± 0,65 mmol/l, respectivamente. El 94,4 % de valores estuvieron entre los límites de concordancia de ± 1,96 desviaciones Standard (método de Bland-Altman). Resultaron altos los coeficientes de correlación intraclase (0,995) y de determinación (0,98). No contrastaron significativamente las diferencias absolutas según el estado de ayuno o no (p=0,3103). Conclusiones:el grado de desacuerdo se ajustó al valor aceptado por las normas ISO 15197. El análisis global demuestra que este glucómetro es suficientemente exacto y preciso para su uso en Cuerpo de Guardia, independientemente del estado de ayuno o no.

Introduction: measurement of a medical parameter through different methods demands assessment of the agreement between them. Objective: to determine the disagreement between glucose levels obtained by a glucometer and the customary method of laboratory, in the emergency room. Methods: an observational study was performed in patients attended at emergency room of Vladimir I. Lenin Hospital, in Holguín, Cuba, with requested determination of blood glucose levels. The study was carried out during March, 2013. The sample size was calculated taking into account a 5 % of accepted disagreement by the International Organization of Standardization criteria (ISO 15197:2003), being 72 the obtained number. A simple random sampling and exclusion criteria were also applied. Glucose blood levels were assessed using RapiglucoTest reference method and a glucometer SUMASENSOR SXT. Results: patients were 58.7± 18.3 years, 54.2 % were female, 51.4% diabetics, and 70.8 % nonfasting. Mean absolute relative error was 9.5± 8.07%. There was 4.8% of disagreement between methods. Skew and precision were 0.40 mmol/L and ± 0.65 mmol/l, respectively. 94.4% of values were between the limits of 1.96 standard deviation (Bland-Altman method). Both Intraclass coefficient correlation (0.995) and determination coefficient (0.98) reached high values. No significant disparity between absolute differences were assessed depending upon fasting state (p=0.3103). Conclusions:the disagreement between methods corresponded to the admissible threshold stablished by ISO criteria. This and the rest of the analysis indicate that this glucometer is both accurate and precise for its intended use in the emergency room setting, even in nonfasting individuals.

Evaluation of the Wisecheck Glucose Monitoring System

BACKGROUND: Glucometers are widely used for self-monitoring and point-of-care testing in diabetes management. We evaluated the performance of the recently developed Wisecheck Glucose Monitoring System (Wisemeditech, Korea) compared to that of 2 other well-known glucometer systems. METHODS: The Wisecheck glucometer was evaluated for precision, linearity, and carryover rate. One-hundred fifty samples samples were tested, and the results obtained from the Wisecheck glucometer, ACCU-CHEK Performa (Roche Diagnostics, Germany) and SD GlucoLink (SD Diagnostics, Korea) were compared to those obtained using the laboratory reference method from the Toshiba 200FR (Toshiba, Japan), according to the Clinical and Laboratory Standards Institute (CLSI) guidelines. RESULTS: The coefficient of variation (CV) values for within-run imprecision at low, middle, and high levels were 2.06%, 1.02%, and 2.02%, respectively, and the CV values for total-run imprecision at low, middle, and high levels were 2.98%, 2.41%, and 1.88%, respectively. In the linearity test, the coefficient of determination (R2) was 0.9985 in glucose concentration ranging from 48.6 mg/dL to 428 mg/dL (P<0.0001). The results obtained using the Wisecheck glucometer were well correlated with those obtained using the Toshiba 200FR (R2=0.980, P<0.0001). The carryover rate was 0.12%. CONCLUSIONS: The Wisecheck glucometer showed good precision, linearity, and correlation with the reference method. It provided rapid and reliable measurements of blood glucose levels and seemed appropriate for use in diabetes management.

Self-monitoring Glucometers: How Accurate Are They? / 임상당뇨병

Glucometers offer a simple and rapid method of self-monitoring blood glucose levels and are widely used by diabetic clinics and patients. The accuracy of a glucometer depends on the meter's performance as well as the user's proficiency level. It is also important to regularly use and calibrate the meter it in order to maintain consistent readings. Since glucometers are considered clinically accurate if the result is within +/- 15 mg/dL of the results of the manufacturer's measurement procedure at glucose concentrations or = 75 mg/dL. It is crucial to compare the meter's result with a lab test result at least once a year in order to maintain the reliability of the meter. Diabetes educators should have thorough knowledge of each meter and be aware of its accuracy so that he or she can properly and accurately educate diabetic patients.

Performance Evaluation of CareSens PRO Glucose Monitoring System / 임상검사와정도관리

BACKGROUND: Point-of-care testing (POCT) glucometers are widely used for the management of diabetic patients. We evaluated the analytical performance of the recently developed glucometer CareSens PRO (i-SENS Inc., Korea). METHODS: Linearity, precision, and correlation were evaluated according to the Clinical and Laboratory Standards Institute guidelines. Five levels of glucose obtained from patient samples were used to determine the linearity of the device response. Control materials with low, medium, and high levels of glucose were evaluated with two different CareSens PRO glucometers to determine their precision. Correlations were evaluated between venous plasma analyzed with Synchron CX3 Delta (Beckman Coulter Inc., USA) and capillary whole blood analyzed with CareSens PRO, and between venous whole blood analyzed with ADAMS GA-1171 (Arkray, Inc., Japan) and venous whole blood analyzed with CareSens PRO, respectively. The effect of hematocrit was assessed. RESULTS: The linearity in the glucose range of 25.5 to 535.0 mg/dL was R2=0.9988. The coefficients of variations (CVs) of within-run precision were 2.06 to 3.47% and the CVs of total precision were 2.99 to 5.38%. The correlations were as follows: r=0.9660 in the range of 68.0 to 404.0 mg/dL with Synchron CX3 Delta and r=0.9886 in the range of 20.5 to 511.0 mg/dL with ADAMS GA-1171. In the specimens containing glucose above 75 mg/dL, 91.2% and 98.9% of CareSens PRO results were within +/- 20% of the results by Synchron CX3 Delta and ADAMS GA-1171, respectively. Hematocrit influenced the glucose concentration. CONCLUSIONS: CareSens PRO displayed acceptable linearity and precision. For clinical application, it is necessary for the improvement of comparable analytical performance and careful interpretation according to hematocrit concentration.

Possible Revival of Atrophied Islet Cells of the Pancreas by Vernonia amygdalina in Alloxan Induced Diabetic Rats.

The Possible Revival of atrophied islet cells of the pancreas by Vernonia amygdalina in alloxan-induced diabetic rats was evaluated. Twenty rats were divided into five groups (1, 2, 3, 4 and 5) of four rats each. Group 1 rats were given only feed and distilled water (normal control) throughout the period of the experiment. Group 3, 4 and 5 rats were pretreated with 250mg/kg body weight of the extract for 7, 14 and 21 days respectively. Diabetes was induced in rats in group 2, 3, 4 and 5 with 150mg/kg of body weight of alloxan monohydrate. Group 2 rats were used as the experimental control. Fasting blood glucose of rats in all the groups were measured before and 72 hours after induction of diabetes. The rats were sacrificed after 72 hours and the pancreas was histopathologically analysed. The result showed a significantly high blood glucose level in group 2 rats indicating the diabetic state. The blood glucose level of rats in group 3 and 5 reduced significantly (p<0.05) when compared with the value of group 2 rats but not significantly different from group 1 value. Group 4 showed a significantly (p<0.05) high blood glucose level when compared with the base-line. The histopathology revealed atrophied islet of Langerhans in group 2 rats. Group 3 and 5, showed reviving islet cells and group 4 showed increased lymphoid follicles and neutrophills. The results suggest that the aqueous extract of V. amygdaliana has a protective effect against alloxan induced pancreatic damage and potential to revive damaged islet cells.

Validity of Two Point-of-Care Glucometers in the Diagnosis of Neonatal Hypoglycemia.

Objective: To estimate validity of two point-of-care glucometers for the diagnosis of neonatal hypoglycemia and to determine the glucometer’s cut-off values for which standard laboratory confirmatory test are no longer needed. Design: Prospective study. Settings: A tertiary care, university hospital in Bangkok, Thailand. Participants: The study included 180 blood specimens from 166 high-risk neonates aged between 1-24 hours. Results: On average, most of the blood glucose read-outs from the Nova StatStrip and SureStep were higher than laboratory plasma glucose throughout the glucose range with mean differences (SD) of 11.2 (8.4) mg/dL and 13.7 (6.8) mg/dL, respectively. Sensitivity of Nova StatStrip and SureStep were 62% and 53.3%, respectively. Specificity and positive predictive value of both glucometers were 100%. Negative predictive values of both glucometers were approximately 85%. The cut-off levels with 100% negative predictive values were 63 mg/dL and 62 mg/dL for Nova StatStrip and SureStep, respectively. Conclusions: None of the glucometers in this study has sufficient validity to replace laboratory testing in diagnosing hypoglycemia. Confirmatory plasma glucose for diagnosis of hypoglycemia is needed when POC readings are between 39 and 63 mg/dL for Nova StatStrip and between 39 and 62 mg/dL for SureStep.

Antidiabetic activity of Adina cordifolia (Roxb) leaves in alloxan induced diabetic rats

Objective: To investigate the antidiabetic activity of hydro-alcoholic extract of Adina cordifolia (Roxb.) leaves (HAEACL) in alloxan induced diabetic rats at 250 and 500 mg/kg doses. Methods:Glibenclamide (10 mg/kg, s.c.) was used as the standard which produced a significant reduction in blood glucose levels. The blood glucose levels of experimental animals were determined at 0, 2, 4 and 6 h after treatment with the plant extract by using glu-oxidase peroxidise reactive strips and glucometer. Results: Treatment with HAEACL at 500 mg/kg dose decreased the blood glucose level significantly. However, the lower doses (250 mg/kg) of HAEACL produced a little decrease in blood glucose level. It showed that there was a dose dependent decrease in blood glucose level in the alloxan induced diabetic rats as compared to the control group. Conclusions: The present study shows that HAEACL possessed significant antidiabetic activity.

Evaluation of ACCU-CHEK(R) Inform II Blood Glucose Meter and ACCU-CHEK(R) Performa Strip / 임상검사와정도관리

BACKGROUND: Self-monitoring of blood glucose levels is recommended for all diabetic patients who receive insulin treatment, because such monitoring of glucose levels may aid in achieving better control in type II diabetes. Further, the use of point-of-care (POC) blood glucose testing in hospitals has increased substantially. In the present study, we validated the performance of ACCU-CHEK(R) Inform II Blood Glucose Meter and ACCU-CHEK(R) Performa Strip (Roche Diagnostics, Germany). METHODS: We evaluated the precision, accuracy, and maltose interference of the ACCU-CHEK(R) Inform II Blood Glucose Meter and ACCU-CHEK(R) Performa Strip. Further, precision was evaluated using dedicated quality control (QC) and Bio-Rad Whole Blood (WB) QC materials (Meter Trax(TM) Control; Bio-Rad, USA). Forty samples were used to compare the results obtained using the ACCU-CHEK(R) Inform II Blood Glucose Meter and ACCU-CHEK(R) Performa Strip with those obtained using the clinical chemistry analyzer Hitachi 7600 (Hitachi, Japan). Maltose interference was assessed at 2 glucose concentration levels at 3 maltose concentration levels. RESULTS: For each concentration level of control materials, within-run coefficient of variation (CV) and total CV obtained were less than 5%. Good correlation was obtained using the Hitachi 7600 (y = 1.02x - 0.18; r 2 = 0.996; N = 40). Effects of maltose interference were less than 10%. CONCLUSIONS: Thus, the ACCU-CHEK(R) systems show good precision and correlation with the routine clinical chemistry analyzer and allow only minimal effects of maltose interference.

The Education Effect of Glucometer Use on the Glucose Levels and the Glucose Value Comparison among Diverse Glucometers / 임상당뇨병

Self-monitoring of blood glucose (SMBG) and point-of-care testing are widely used in the management of diabetic outpatients. However, SMBG records are sometimes inaccurate, and may differ from glucose values measured in the hospital. Therefore, the aim of our study was to evaluate the effects of patient education regarding glucometer use on blood glucose levels and to compare the glucose values obtained by six different types of glucometers currently used in Korea. Fifty-six diabetic patients participated in the present study. Each patient visited the hospital in a fasting state. Fasting plasma glucose (FPG) levels in capillary blood samples were measured by doctors and by the patients themselves before and after patient education sessions. Then, glucose levels were measured with each of the six glucometers by doctors and by the patients themselves. The differences between FPG and glucose values measured using glucometers were compared, and their relationships with HbA1c were also assessed. There were no significant differences between glucose levels measured by patients regardless of glucometer education. We obtained similar results for differences between glucose levels measured by patients and doctors. Patient HbA1c levels were not correlated with differences in measurements between glucometers and FPG. Measurements of glucose levels by the six different glucometers did not differ significantly. Our study indicates that education about SMBG, including glucometer handling, is important to increase SMBG accuracy, but that errors in SMBG records are trivial for glucometer users and that the different glucometers used in Korea demonstrate similar accuracy.

Accuracy of different blood glucose measurements in a medical intensive care unit / 中华急诊医学杂志

Objective To evaluate the accuracy of five blood glucose measurements commonly used in ICU and to determine the potential factors interfering the accuracy. Method This prospective study carried out in consecutively enrolled 49 patients stayed more than 48 hours in the medical ICU of Peking Union Medical College Hospital from November 2007 to January 2008. A total of 130 blood samples were measured to determine blood glucose with five different methods, and the biochemistry analyzer in central laboratory was regarded as reference method for comparison with other four methods, ( 1 ) capillary blood/glucometer;(2) arterial blood/glucometer; (3) arterial blood/blood gas analyzer; and (4) arterial blood/biochemistry analyzer. The accuracy of a method tested was judged by the difference in level of blood glucose between it and reference method, correlation coefficient, bias correction factor and discrepancy. The independent factors for the discrepancies were identified by multivariate logistic regression. Results The values of differences in level of blood glucose between above four methods and the reference were ( 1.7 ± 1.4) mmol/L,( 1.6 ± 1.4 ) mmol/L, ( 1.1 ± 1.2) mmol/L, and (0.5 ± 1.2 ) mmol/L, respectively. The rates of discrepancy were 66.9%, 63.8%, 40.0% and 23.8%. The correlation coefficients were 0. 844, 0. 845, 0. 895and 0. 896. The bias correction factors were 0. 821,0.831,0.914 and 0. 979. Decrease in hematocrit was statistically associated with the discrepancy between glucometer analysis methods and the reference, with OR of 0.923 for capillary blood ( P = 0.03 ) and 0. 912 for arterial blood( P = 0.014), respectively. Conclusions Glucometer analysis poorly correlated with reference method and blood gas analysis in ICU patients. Decrease in hematocrit significantly increased the degree of discrepancy in glucose measurements between glucometer analysis and the reference.

Evaluation of the Analytical Performance of NOVA StatStrip(R) Blood Glucometer in a Peritoneal Dialysis Setting / 임상검사와정도관리

BACKGROUND: The use of point of care glucometer is widely established. However, the reliability of glucometer can vary according to the type of patients tested. Chemical interference with some current glucometer has been observed in patients undergoing peritoneal dialysis. StatStrip(R) (Nova Biomedical, USA) has been designed to compensate for this interference effect. So we compared the analytic performance and interference response of StatStrip(R) to two conventional glucometers. And we also evaluated the interference response with samples in patients undergoing peritoneal dialysis. METHODS: StatStrip(R) and two other glucometers were compared for linearity, imprecision, correlations with Advia 2400(TM) (Bayer Diagnostics, USA). Interference by lactate, maltose, were evaluated. Interferences in 20 samples of patients undergoing peritoneal dialysis were also evaluated. RESULTS: The coefficients of variation (CVs) of within-run precision were 1.70-3.77% and CVs of total precision were 1.98-3.99%. The linearity was R2=0.9776-0.988 (P<0.001). High correlation was found in each glucometer and the Advia 2400(TM). But all the glucometers showed a variable positive or negative bias compared with reference method. Including samples of patients undergoing peritoneal dialysis, maltose did not significantly influence the glucose concentration in StatStrip(R) and one of the conventional glucometers within 20% difference range. Lactate and hematocrit did not significantly influence the glucose concentration in all glucometers. CONCLUSIONS: StatStrip(R) shows good linearity, precision, correlation with the reference method and shows minimal interference effects. Our results indicate that StatStrip(R) also has clinical reliability when used in a peritoneal dialysis setting.

Evaluation of CareSens(R) N Glucometer Glucose Monitoring System / 임상검사와정도관리

BACKGROUND: Point-of-care testing (POCT) glucometers are widely being used for management of diabetes. We examined the analytical performance of the recently developed glucometer CareSens(R) N Glucometer (i-SENS Inc., Korea). METHODS: CareSens N was evaluated for linearity, precision, and the effect of hematocrit. Method comparison using the laboratory reference method, hexokinase method by Hitachi 7600 (Hitachi Co., Japan) was also performed. Other glucometers, Accu-Chek(R) inform (Roche Diagnostics LTD., Germany) and Onetouch(R) ultra(TM) (Lifescan Inc., USA) were evaluated for the same categories according to CLSI guidelines. RESULTS: CareSens N Glucometer showed a good linearity and precision. The linearity was r=0.9965. The coefficients of variations (CVs) of within-run precision were 0.73-1.98% and CVs of total precision were 1.65-2.71%. A high correlation (glucose by CareSens N = 0.9767 x glucose by Hitachi 7600 + 4.1734, r=0.9614) was also shown between the CareSens N glucometer and Hitachi 7600 in the central laboratory. Other glucometers showed a good linearity. The within-run and total-run CVs of other glucometers were within 10%. Although differences with the reference method were within allowable ranges, all glucometers showed variable bias compared with the reference method. Overestimation or underestimation of glucose values were observed by change of hematocrit in range of 31.1 to 51.2%. CONCLUSIONS: CareSens N showed good linearity, precision, and correlation with reference method. CareSens N provided reliable result of blood glucose and seems appropriate for clinical use in the management of diabetic patients.

Analytical Performance Evaluation of Glucose Monitoring System Following ISO15197 / 대한진단검사의학회지

BACKGROUND: We have evaluated the analytical performance of SureStep Flexx (Johnson and Johnson, USA) which can report the plasma equivalent glucose test results and be connected to the hospital information networks, following ISO15197 analytic procedure for glucometer for the first time. METHODS: Adopting the guidelines of ISO15197, we measured the precision of ten glucometers from their repeatability and intermediate precision, and determined the accuracies of the glucometer, comparing to those of GEM Premier 4000 (Instrumentation Laboratory, USA). In addition, the guidelines of CLSI EP9-A2 and EP6-A were applied to correlate between data of glucometer and those of laboratory reference method by TBA-200FR (Toshiba Medical Systems, Japan) and to examine its linearity of glucose concentrations measured by SureStep Flexx. We used the clinical specimens and commercial control materials. RESULTS: Repeatabilities and intermediate precisions of those glucometers were 4.0-7.3%, and 4.3-6.2%, respectively. When glucose levels are under 75 mg/dL, the difference between results of those meters and the reference values were within +/-6 mg/dL. However when glucose levels are over 75 mg/dL, those differences were within +/-12.7%. These results were acceptable for the ISO15197 criteria in all glucose concentrations. The glucose concentrations showed the clinically relevant linearity in the range from 36 mg/dL to 491 mg/dL. Moreover, Error Grid Analysis showed that all glucose results were in "zone A", which means that these values were clinically accurate. CONCLUSIONS: This study showed that SureStep Flexx can provide reliable results for patients and clinicians to manage the diabetes mellitus, satisfying the ISO15197 criteria.

Evaluation of GLUCOCARD X-METER Glucose Monitoring System / 대한진단검사의학회지

BACKGROUND: Point-of-care testing (POCT) glucometers are increasingly being used for making important therapeutic decisions and managing diabetes. We examined the analytical performance of GLUCOCARD X-METER (ARKRAY Global Business Inc., Japan) against three other glucometers and a reference laboratory method. METHODS: We evaluated the analytical performance of GLUCOCARD X-METER in comparison with three other glucometers. Studies on precision, linearity, the analysis time, and effects of hematocrit and temperature were carried out and the results were compared with those of the laboratory reference method (hexokinase method by Hitachi 760, Hitachi Co., Japan). RESULTS: GLUCOCARD X-METER showed a good linearity and within-run and total-run precision. Comparison between each glucometer and the Hitachi 7600 showed a good correlation. Although differences with the reference method were within an allowable range, all glucometers showed variable bias. Application of an insufficient amount of blood could produce some changes in test results. Changes in hematocrit were found to cause overestimation or underestimation of glucose values. For some test strips, the results were affected by prolonged exposure to room temperature or 4degrees C refrigerator. CONCLUSIONS: GLUCOCARD X-METER showed a good analytical performance in linearity, precision, and comparison. The effect of hematocrit, sample volume, and storage condition for test strips were noted and glucometers had variable deviations to both directions from laboratory reference values (<20%). The GLUCOCARD X-METER provided rapid and reliable measurements of blood glucose. It could be appropriate for monitoring blood glucose values in diabetic patients.

Evaluation of Gluchec Fine Glucometer / 임상검사와정도관리

BACKGROUND: We evaluated the analytical performance of the recently developed glucometer Gluchec Fine (KMH Co., Ltd., Anyang, Gyeonggi, Korea) in Korea. METHODS: Within-run precision and total precision were assessed according to CLSI guideline EP5-A2 with control material of low and high level. Linearity was evaluated in the range of 51-473 mg/dL made by patient samples. Correlations with SureStep (Lifescan, Milpitas, CA, USA) and TBA200-FR (Toshiba, Tokyo, Japan) were evaluated using 99 patient samples in the range of 23-473 mg/dL. Interferences by acetaminophen, ascorbic acid, bilirubin, cholesterol, galactose, and uric acid were elvauated according to CLSI guideline EP7-A. Effect of hematocrit, user variability and reagent stability were assessed. RESULTS: The CVs of within-run precision were 2.5-3.0% and the CVs of total precision were 3.6-4.7%. The linearity was R(2)=0.998. The correlations with TBA200-FR (R=0.982) and Surestep (R=0.984) were acceptable. Glucose concentrations measured by Gluchec Fine were lower than those by TBA200-FR (mean 2.7%, 95% CI 0.3-5.1%) in the range of 23-473 mg/dL. Acetaminophen, galactose, and cholesterol did not interfere with glucose measurements on Gluchec Fine. High concentrations of ascorbic acid, bilirubin, and uric acid resulted in positive interferences. Hematocrit and user variability did not significantly influence the glucose concentration. Reagent was stable until one week after opening. CONCLUSIONS: Gluchec Fine glucometer showed acceptable and comparable analytical performance. This instrument can be used for therapeutic monitoring of diabetes patients.