An insulin-dose error assessment grid: A new tool to evaluate glucose meter performance.

OBJECTIVE: To develop a tool to assess the clinical accuracy of glucose meter performance using an insulin dosing protocol to assess the frequency and extent of error in insulin dose categories. METHODS: Retrospective comparison of 1815 glucose meter and central laboratory glucose results obtained from 1698 critically ill patients was conducted using the Parkes error grid, Surveillance error grid and an insulin dose error assessment grid with a sliding scale insulin dosing protocol used to manage critically ill patients. RESULTS: Parkes error grid and Surveillance error grid analyses indicated little risk conferred with the glucose meter results. Insulin dose error assessment grid complemented the aforementioned consensus error grids by determining quantifiable metrics, insulin dose category errors. Insulin dose error analysis indicated that 76.8% (1395/1815) would not have any change in insulin dose, 99.2% (1800/1815) within ±1 insulin dose category, 99.9% (1814/1815) within ±2 categories and 100% within ±3 insulin dose categories. CONCLUSIONS: Analysis with an insulin dose error grid provides information about the frequency and extent of insulin dose category errors with a specific insulin dosing protocol and describes potential clinical impact of glucose meter error.

Investigating interferences of a whole-blood point-of-care creatinine analyzer: comparison to plasma enzymatic and definitive creatinine methods in an acute-care setting.

BACKGROUND: Although measurement of whole-blood creatinine at the point of care offers rapid assessment of renal function, agreement of point-of-care (POC) results with central laboratory methods continues to be a concern. We assessed the influence of several potential interferents on POC whole-blood creatinine measurements. METHODS: We compared POC creatinine (Nova StatSensor) measurements with plasma enzymatic (Roche Modular) and isotope dilution mass spectrometry (IDMS) assays in 119 hospital inpatients. We assessed assay interference by hematocrit, pH, pO(2), total and direct bilirubin, creatine, prescribed drugs, diagnosis, red blood cell water fraction, and plasma water fraction. RESULTS: CVs for POC creatinine were 1.5- to 6-fold greater than those for plasma methods, in part due to meter-to-meter variation. Regressioncomparison of POC creatinine to IDMS results gave a standard error (S(y|x)) of 0.61 mg/dL (54 µmol/L), whereas regression of plasma enzymatic creatinine to IDMS was S(y|x) 0.16 mg/dL (14 µmol/L). By univariate analysis, bilirubin, creatine, drugs, pO(2), pH,plasma water fraction, and hematocrit were not found to contribute to method differences. However, multivariate analysis revealed that IDMS creatinine, red blood cell and plasma water fractions, and hematocrit explained 91.8% of variance in POC creatinine results. CONCLUSIONS: These data suggest that whole-blood POC creatinine measurements should be used with caution. Negative interferences observed with these measurements could erroneously suggest adequate renal function near the decision threshold, particularly if estimated glomerular filtration rate is determined. Disparity between whole-blood and plasma matrices partially explains the discordance between whole-blood and plasma creatinine methods.

Evaluation of different disinfectants on the performance of an on-meter dosed amperometric glucose-oxidase-based glucose meter.

BACKGROUND: Off-meter dosed photometric glucose-oxidase-based glucose meters have been reported to be susceptible to interference by hydrogen-peroxide-based disinfecting agents. The objective of this study was to determine if a single application of hydrogen-peroxide-containing Accel® wipe to disinfect an on-meter dosed amperometric glucose-oxidase-based glucose meter will influence its performance. METHOD: The performance of five on-meter dosed amperometric glucose-oxidase-based glucose meters was determined before and after disinfecting the devices with a single application of either CaviWipes® (14.3% isopropanol and 0.23% diisobutyl-phenoxy-ethoxyethyl dimethyl benzyl ammonium chloride) or Accel (0.5% hydrogen peroxide) wipes. Replicate glucose measurements were conducted before disinfecting the devices, immediately after disinfecting, and then 1 and 2 min postdisinfecting, with measurements in triplicate. Analysis was sequentially completed for five different meters. Results were analyzed by a two-way analysis of variance (Analyze-it software). RESULTS: No clinical (<0.3 mmol/liter) or statistical differences (p > .05) in glucose concentration were detected when the on-meter dosed amperometric glucose-oxidase-based glucose meters were disinfected with either CaviWipes or Accel wipes and measured immediately or 1 or 2 min postdisinfecting. No clinically significant difference in glucose concentration was detected between meters (<0.3 mmol/liter). CONCLUSION: The on-meter dosed glucose oxidase amperometric-based glucose meters are not analytically susceptible to interference by a single application of hydrogen-peroxide-containing Accel disinfectant wipes.

Estimates of total analytical error in consumer and hospital glucose meters contributed by hematocrit, maltose, and ascorbate.

BACKGROUND: Patients and physicians expect accurate whole blood glucose monitoring even when patients are anemic, are undergoing peritoneal dialysis, or have slightly elevated ascorbate levels. The objective of this study was to estimate analytical error in two consumer and two hospital glucose meters contributed by variations in hematocrit, maltose, ascorbate, and imprecision. METHODS: The influence of hematocrit (20-60%), maltose, and ascorbate were tested alone and in combination with each glucose meter and with a reference plasma glucose method at three concentrations of glucose. Precision was determined by consecutive analysis (n=20) at three levels of glucose. Multivariate regression analysis was used to estimate the bias associated with the interferences, alone and in combination. Total analytical error was estimated as |% bias|+1.96 (% imprecision). RESULTS: Three meters demonstrated hematocrit bias that was dependent upon glucose concentration. Maltose had profound concentration-dependent positive bias on the consumer meters, and the extent of maltose bias was dependent on hematocrit. Ascorbate produced small but statistically significant biases on three meters. Coincident low hematocrit, presence of maltose, and presence of ascorbate increased the observed bias and was summarized by estimation of total analytical error. Among the four glucose meter devices assessed, estimates of total analytical error in glucose measurement ranged from 6 to 68% under the conditions tested. CONCLUSIONS: The susceptibility of glucose meters to clinically significant analytical biases is highly device-dependent, and low hematocrit exacerbated the observed analytical error.

A mathematical model to assess the influence of hematocrit on point of care glucose meter performance.

OBJECTIVES: To develop and apply a mathematical model of the relationship between hematocrit, meter glucose and reference glucose concentrations as a tool for evaluation of whole blood glucose meters. DESIGN AND METHODS: Patient blood gas specimens were used to compare the LifeScan SureStep Flexx and the Nova StatStrip glucose meters with reference results obtained from a Radiometer 725 blood gas analyzer. Linear regression analysis was conducted to determine the extent that patient hematocrit and reference glucose concentrations predicted the performance of the glucose meters. RESULTS: Bland-Altman graphic analysis depicted that both glucose meters showed variance with the reference method. A mathematical model was derived from IFCC consensus equations that relate glucose meter results, hematocrit and plasma glucose values. Using the model, multivariate regression depicted that hematocrit affected the results of the SureStep Flexx meter in a manner dependent on the glucose concentration, whereas the StatStrip meter was not affected by hematocrit. CONCLUSIONS: Linear regression can be used to quantify the extent of hematocrit interference on the performance of glucose meters.

Performance of a new interference-resistant glucose meter.

OBJECTIVES: Glucose meters are widely used in self and hospital monitoring of blood glucose. We examined the analytical performance of a StatStrip glucose monitoring system. DESIGN AND METHODS: Linearity, % recovery and within-run imprecision were studied using glucose-spiked whole blood. A total of 120 heparinized samples were used in method comparison using a plasma hexokinase on the Dimension RxL MAX analyzer as the comparison method. Common interferences were tested on the StatStrip, Accu-Chek Advantage and the MediSense Optium glucose meters at low, middle and high glucose levels. RESULTS: The StatStrip assay showed excellent linearity and recovery. The coefficient of variations for imprecision were <5%. This meter correlated well with the comparison method (y=0.994X+0.03; r=0.995, S(y/x)=0.05 mmol/L, bias=-0.01 mmol/L). Of the three meters tested, only the StatStrip showed interference <10% for all spiked levels of acetaminophen, ascorbic acid, maltose and hematocrit at three levels of glucose tested. CONCLUSIONS: The StatStrip meter showed good performance and is suitable for point-of-care hospital glucose testing.

Evaluation of the impact of hematocrit and other interference on the accuracy of hospital-based glucose meters.

BACKGROUND: Most glucose meter comparisons to date have focused on performance specifications likely to impact subcutaneous dosing of insulin. We evaluated four hospital-based glucose meter technologies for accuracy, precision, and analytical interferences likely to be encountered in critically ill patients, with the goal of identifying and discriminating glucose meter performance specifications likely to impact intensive intravenous insulin dosing. METHODS: Precision, both within-run and day-to-day, was evaluated on all four glucose meters. Accuracy (bias) of the meters and analytical interference were evaluated by comparing results obtained on whole blood specimens to plasma samples obtained from these whole blood specimens run on a hexokinase reference method. RESULTS: Precision was acceptable and differed little between meters. There were significant differences in the degree to which the meters correlated with the reference hexokinase method. Ascorbic acid showed significant interference with three of the four meters. Hematocrit also affected the correlation between whole blood and plasma hexokinase glucose on three of the four glucose meters tested, with the magnitude of this interference also varying by glucose meter technology. CONCLUSIONS: Correlation to plasma hexokinase values and hematocrit interference are the main variables that differentiate glucose meters. Meters that correlate with plasma glucose measured by a reference method over a wide range of glucose concentrations and minimize the effects of hematocrit will allow better glycemic control for critically ill patients.

MODULAR ANALYTICS: A New Approach to Automation in the Clinical Laboratory.

MODULAR ANALYTICS (Roche Diagnostics) (MODULAR ANALYTICS, Elecsys and Cobas Integra are trademarks of a member of the Roche Group) represents a new approach to automation for the clinical chemistry laboratory. It consists of a control unit, a core unit with a bidirectional multitrack rack transportation system, and three distinct kinds of analytical modules: an ISE module, a P800 module (44 photometric tests, throughput of up to 800 tests/h), and a D2400 module (16 photometric tests, throughput up to 2400 tests/h). MODULAR ANALYTICS allows customised configurations for various laboratory workloads. The performance and practicability of MODULAR ANALYTICS were evaluated in an international multicentre study at 16 sites. Studies included precision, accuracy, analytical range, carry-over, and workflow assessment. More than 700 000 results were obtained during the course of the study. Median between-day CVs were typically less than 3% for clinical chemistries and less than 6% for homogeneous immunoassays. Median recoveries for nearly all standardised reference materials were within 5% of assigned values. Method comparisons versus current existing routine instrumentation were clinically acceptable in all cases. During the workflow studies, the work from three to four single workstations was transferred to MODULAR ANALYTICS, which offered over 100 possible methods, with reduction in sample splitting, handling errors, and turnaround time. Typical sample processing time on MODULAR ANALYTICS was less than 30 minutes, an improvement from the current laboratory systems. By combining multiple analytic units in flexible ways, MODULAR ANALYTICS met diverse laboratory needs and offered improvement in workflow over current laboratory situations. It increased overall efficiency while maintaining (or improving) quality.