Accuracy and precision of a portable anticoagulation monitor in a clinical setting.

BACKGROUND--Office-based anticoagulation monitors offer significant advantages in convenience, yet their performance has been inadequately characterized. METHODS--We characterized the performance of a portable anticoagulation monitoring system with respect to precision and agreement with a reference laboratory. Eighty-five patients from a university outpatient anticoagulation clinic provided 143 whole blood sample pairs for evaluating agreement between the monitor and the laboratory. Fifty-four patients each provided a second pair of samples for assessing the monitor's precision, and 23 pairs of measurements from the reference laboratory were used for assessing the laboratory's precision. Anticoagulation was measured using International Normalized Ratio (INR) values. Agreement between monitor and laboratory was evaluated as the difference between paired measurements. Precision was calculated as the within-patient standard deviation based on paired values. RESULTS--Within the range of 2.0 to 3.0 INR units, the monitor yielded values that were up to 0.3 units higher on average than the laboratory values. Within the range of greater than 3.0 to 4.5 INR units, the monitor yielded values that were up to 0.5 units lower on average than the laboratory values. Seventy-five percent of paired monitor and laboratory values were within 0.7 INR units; 90% were within 0.9 units. Within-patient standard deviation was 0.23 units for the monitor and 0.19 units for the laboratory. CONCLUSIONS--The monitor differed systematically from the laboratory and was moderately less precise. The magnitude of these effects was not great, however, and accuracy was best at around INR = 3.0, the border between low and high therapeutic ranges. The clinic-based monitor is useful for patients requiring frequent surveillance of anticoagulation status.     

Accuracy of spirometric and flow-volume indices obtained by digitizing volume-time tracings

We tested the accuracy of a new system for deriving standard spirometric indices, maximal expiratory flow rates, and slope ratios from volume-time tracings. A computer-based technique employing a hand-operated cursor was used to put discrete values of volume and time into a memory array. Spirometric values obtained on 102 subjects using the computer system were compared with the corresponding "hand-read" values. The difference between the 2 measuring techniques were not significant for the FVC, the FEV75, and the FEF25-75; however, the average FEV1 differed by 6.7 ml (SD, 20.3 ml), which was significant. In addition, 10 subjects performed FVC maneuvers through a spirometer and flowmeter connected in series. Flows and slope ratios obtained from the volume-time tracings were compared with those obtained directly from the flowmeter. There was a high degree of correlation between the 2 types of flow measurements (r = 0.989), whereas slope ratios were less well correlated (r = 0.589). Configurational detail such as the presence of "bumps" on slope ratio versus volume plots were recovered with the computer technique. Using this new system, it is possible for 1 operator to process 10 to 12 sets of spirometry tracings per hour.     

Accuracy and reproducibility of the Assess peak flow meter

The variability of peak flow measurements was studied in 24 patients with airway obstruction, using 12 Assess peak flow meters and a Fleisch pneumotachograph type 4 as a standard. The Assess peak flow meter gave systematic under-readings of 19-34% (low accuracy). The value scale of the Assess peak flow meter should be adjusted. As systematic under-readings do not influence the variability in peak flow measurements, variability was only caused by the random error of the instrument. The random error of the Assess peak flow meter was relatively low: about 4% of the measured peak flow value (high precision). The contribution of the Assess peak flow meter to the total variability of peak flow measurements showed a linear relationship (r = 0.53) with the value of the peak flow rate itself and varied from 9% (at 3 l.s-1) to 86% (at 10.8 l.s-1). Reading errors of the peak flow meter were responsible for about 1% of the total variability. The remaining variability is probably caused by the correctness of the peak flow performance and the motivation of the patient.     

Accuracy and precision of buccal pulse oximetry

Objective

We sought to describe the accuracy and precision of buccal pulse oximetry (SbpO₂) compared with arterial oxygen saturation (SaO₂) and pulse oximetry (SpO₂) in healthy adults at normoxemia and under 3 induced hypoxemic conditions.

Methods

In this prospective, correlational study, SbpO₂, SaO₂, and SpO₂ values were recorded at normoxemia and at three hypoxemic conditions (SpO₂ = 90%, 80%, and 70%) for 53 healthy, nonsmoking adults who were without cardiac or pulmonary disease, baseline hypoxemia, peripheral edema, dyshemoglobinemia, and fever. Bland-Altman analyses were used to assess agreement and precision between SbpO₂ and SaO₂ measures and between SbpO₂ and SpO₂ measures. Data were adjusted to account for a lag time between buccal and finger sites.

Results

When comparing SbpO₂ and SaO₂ values, mean differences of -1.8%, .3%, 2.4%, and 2.6% were evident at the normoxemia, 90%, 80%, and 70% levels, respectively. When comparing SbpO₂ and SpO₂ values, the mean differences were -1.4%, .1%, 3.3%, and 4.7% at the normoxemia, 90%, 80%, and 70% levels, respectively. The SbpO₂ and SaO₂ values met a priori precision criteria (1.6%; 95% confidence limit, -4.9% to 1.3%) at normoxemia. The SbpO₂ and SpO₂ values met precision criteria at normoxemia (1.5%; 95% confidence limit, -4.4% to 1.5%) and 90% (1.9%; 95% confidence limit, -3.6% to 3.8%) conditions, but exceeded precision criteria at the other tested conditions. On average, SpO₂ lagged 21 seconds behind SbpO₂.

Conclusion

Buccal oximetry is an inaccurate and imprecise method of assessing SpO₂ when oxygen saturation is <90%. The divergence between SbpO₂ and both SaO₂ or SpO₂ values increased as hypoxemia worsened. The buccal method overestimated oxygen saturation in proportion to the degree of hypoxemia. Such overestimates may lead nurses to conclude falsely that a patient's arterial oxygen saturation is acceptable when further assessment or intervention is warranted.     

Accuracy and precision of fourteen pulse oximeters

Two sets of seven pulse oximeters (Criticare CSI-502; Nellcor-N200; Datex-Satlite; Physio-Control-Lifestat 1600; Critikon-Oxyshuttle; Ohmeda-Biox 3700; Ohmeda-Biox 3740; Radiometer-Oxi; Spectramed-Pulsat; Kontron-7840; Biochem-Ox2000; Invivo-4500; Engstr?m-EOS; Novametrix-505) were studied in two groups of eight healthy subjects, aged 26-50 yrs. The transcutaneous oxygen saturation (SpO2) was compared with arterial oxygen saturation (SaO2) measured in simultaneously with drawn blood samples (OSM2 Radiometer) at four 20 min steady-state levels of inspired oxygen fraction (FIO2) (0.21, 0.10, 0.08 and 0.07; SaO2 99-55%) in a conditioned chamber. Both the error in accuracy (mean SpO2-SaO2 difference), and the error in precision (SD of the differences) remained less than 3% for the two highest FIO2 levels (SaO2 greater than 83%) but, during deeper hypoxia, they were increased to 8% and 5%, respectively. An instrumental systematic bias affected accuracy in particular. We concluded that a good agreement between SpO2 and SaO2, as reflected by the Bartko's intraclass coefficient, was observed in nine instruments.     

Accuracy of glucose meter use in gestational diabetes

Glucose monitoring is essential for the successful management of gestational diabetes. The accuracy of glucose meters is typically determined over a much wider range of glucose values than that commonly encountered in gestational diabetes. The objective of our study was to look at the accuracy of self-monitoring glucose meters in a clinic setting over a range of glucose values seen in gestational diabetes. We retrospectively analyzed 107 case records of subjects with gestational diabetes, each of whom had three simultaneous laboratory and glucose meter glucose tests. The results were compared using the performance goals that (1) all of glucose meters should have readings within 10% of the reference value and (2) the error grid analysis in the standard format and a modified version suitable for gestational diabetes. We also examined the range of the differences from the reference value. Nearly half of the values (47%) were in excess of 10% of the reference range (either above or below). Close to 15% were in excess of 20% difference from the reference range. Standard error grid analysis showed that 96% of the values fell within sections A of the error grid which are considered acceptable, and 100% fell within sections A and B, differences which are generally considered to have no major impact on care. The modified version of the error grid analysis demonstrated that 39% of the values were outside the acceptable range. Within subjects, a substantial number (26%) had a range of differences that exceeded 20% difference between each other. Although the meters give reasonable results that might be acceptable for general diabetes care, the results provide some cause for concern in the management of gestational diabetes. Given the need for precision in the setting of pregnancy particularly in making the decision of whether to start or withhold insulin therapy, caregivers need to be cognizant of these inaccuracies.     

Accuracy and utility of a 10-test disk blood glucose meter

We evaluated the clinical accuracy, precision, and ease-of-use of a whole blood referenced glucose meter system that uses a 10-test disk (Ascensia Confirm Blood Glucose Monitoring System, Bayer Healthcare LLC). The meter system was tested by 100 subjects and eight health care professionals at two separate diabetes centers. Meter blood glucose test results, obtained by the subjects and health care professionals, were accurate and correlated well when compared with laboratory results. The means of the subject and healthcare professional blood glucose results were within 4.8% of the laboratory mean glucose result. When compared with laboratory results, the correlation coefficient was 0.96 for subject meter results and 0.97 for health care professional meter results. Error grid analyses demonstrated that all subject and health care professional blood glucose measurements fell within zones A and B ('no effect on clinical action' and 'altered clinical action with little or no effect on clinical outcome,' respectively). Ninety-three percent (93%) of subjects rated the meter system favorably on an 'ease-of-use' questionnaire. A majority of subjects correctly performed blood glucose self-monitoring tasks simply by reviewing the user guide. In summary, this unique meter that uses a 10-test disk was shown to be both accurate and precise, and subjects with diabetes were able to use the system properly with minimal instructions.     

Accuracy and precision of quantitative digital coronary arteriography: Observer-, short-, and medium-term variabilities

Coronary arteriograms are increasingly acquired and stored in digital format, which allows instantaneous review of the pictorial data during the cardiac catheterization procedure. To support the angiographer in choosing the optimal sizes of the recanalization devices and studying the efficacy of the recanalization procedures, we have developed a new analytical software package (Automated Coronary Analysis = ACA) on the Philips DCI (-SX) digital cardiac imaging system. The ACA-package allows the objective and reproducible assessment of the morphologic and functional severity of coronary obstructions. Required user interaction is limited to the definition of the start and end points of the coronary segment to be analyzed. Automated contour detection is based on the use of first and second derivative functions along scanlines perpendicular to the automatically computed vessel pathline in the first iteration and perpendicular to the initial contours in the second iteration. These derivative functions have been modified based on the line spread function of the X-ray imaging chain, which is of particular importance for the accurate measurement of small vessel sizes. Phantom studies have indeed demonstrated that vessel sizes down to 0·66 mm can be measured accurately and reproducibly. Inter- and intraobserver variability studies have demonstrated a variability in the obstruction diameter of 0·11 mm and 0·10 mm, respectively, and in the percent diameter stenosis of 5·64% and 3·18%, respectively. These variability studies have been extended to short-term studies with repeated acquisition in the same angiographic views after 5 min and to medium-term studies with repeated acquisition in the initial angiographic views at the end of the catheterization procedures. With these standardized repeated acquisition and analysis procedures, the variabilities in the obstruction diameters increased to 0·19 and 0·18 mm, respectively, and remained below 6% in the percent diameter stenosis (5·61 % and 5·28%, respectively). With an analysis time of ～15 sec on the DCI-SX, an efficient tool is now available in the catheterization laboratory for the objective and reproducible assessment of vessel dimensions and changes therein as a result of recanalization procedures.     

Accuracy of the hemocue portable glucose analyzer in a large nonhomogeneous population

Several studies have reported inconsistent results between HemoCue (HC) whole blood glucose measurements compared to plasma glucose. We selected a large patient population with diverse pathologies and healthy volunteers to evaluate HC. For this comparison, whole blood glucose concentration was measured using HC and referenced to laboratory plasma glucose. The population (n = 512) included healthy volunteers, diabetics, and patients with heart failure, liver failure, renal failure, renal and liver transplant, and other chronic diseases. Patients were on a wide variety of medications, vitamins, and food supplements. Venous blood samples were collected in tubes containing potassium oxalate and sodium fluoride. Comparison of the results was made using the method of Bland and Altman and ANOVA at three selected glucose ranges. The glucose measurement ([HC + laboratory]/2) ranges were 24-75, 76-129, and 130-404 mg/dL. A positive bias for all three glucose ranges was observed: 38 +/- 17 mg/dL for the high glucose group compared to 24 +/- 9 mg/dL and 22 +/- 10 mg/dL for the middle and low groups, respectively. In the high glucose group 90% of the values were within 10% (R = 0.97) of the laboratory reference values compared to 81% and 55% in the normal and low glucose groups, respectively. HC glucose measurements were generally within two SD from the laboratory plasma reference. HC consistently yielded lower whole blood glucose measurements than plasma with the largest differences seen in the low glucose range (29%). HC measured more consistently at the higher glucose concentrations and was 16% lower than plasma, although the mean absolute error was highest for that range. No significant effects in the bias could be attributed to disease while possible effects from instrument modifications by the manufacturer remain uncertain.     

Clinical evaluation of a portable lactate meter in type I glycogen storage disease

Summary High lactate concentrations occur in type I glycogen storage disease (GSD) whenever glycogenolysis occurs. Not only does hyperlactataemia cause acute clinical deterioration, but chronic lactate elevations have also been associated with many of the long-term complications in GSD. A portable finger-stick blood lactate meter has recently been marketed as a training tool for high-performance athletes, but it has not been tested as a clinical diagnostic tool. This study was performed to assess the accuracy of the portable lactate meter in subjects with GSD I who are predisposed to high lactate concentrations. A total of 166 intravenous and 39 capillary samples from 13 subjects were tested concomitantly on three different lactate meters. The meter readings were compared with the lactate concentration determined by the laboratory gold-standard enzymatic colorimetric assay. Almost no inter-meter variability was found. The lactate meter values had outstanding correlation with the laboratory lactate determination, although the meters were found to run 0.5 mmol/L higher than the laboratory assay. The meter deviation was independent of lactate concentration. More variability was noted with finger-stick capillary lactate determinations, but monitoring of trends with capillary samples should prove valuable as a method for determining long-term control or acute deterioration. The portable lactate meter is a highly accurate tool for monitoring lactate concentrations, and should prove valuable for monitoring metabolic control in patients with GSD type I and other disorders associated with hyperlactataemia.     

Accuracy and precision of the Axis-Shield Afinion hemoglobin A1c measurement device

Background

The Afinion HbA1c (Axis-Shield) is a newer point-of-care device for measurement of hemoglobin A1c (A1C) using a boronate affinity method unlike the more commonly used DCA immunoassay method (Siemens Medical Solutions Diagnostics). The Afinion’s accuracy and precision, when compared with high-performance liquid chromatography (HPLC) and DCA methods, have not been established in pediatric practice settings.

Methods

Capillary blood was collected from 700 subjects with diabetes mellitus at seven Pediatric Diabetes Consortium sites. Each subject’s A1C was measured locally using Afinion and DCA devices, and by a central laboratory (University of Minnesota) using a Tosoh HPLC method. In addition, repeated measurements on six whole blood samples provided by the National Glycohemoglobin Standardization Program (NGSP) were taken at three clinical centers using the Afinion and DCA methods and centrally using the Tosoh HPLC method to assess the precision of each device.

Results

The coefficient of variation for measurements of whole blood samples for precision analysis was 2% for Afinion, 3% for DCA, and 1% for HPLC. In the patient samples measured at the seven clinic sites, the Afinion generated higher A1C results than the HPLC (mean difference = +0.15; p < 0.001), while the DCA produced lower values (mean difference = -0.19; p < 0.001). The absolute differences with HPLC were similar for the Afinion and DCA (median 0.2%) with a slight advantage for the Afinion when compared with DCA (p < 0.001 by rank test). The DCA tended to read lower than HPLC, particularly at high A1C levels (p < 0.001), while the Afinion’s accuracy did not vary by A1C.

Conclusions

When compared to the central laboratory HPLC method, the differences between the results of the Afinion and DCA devices are clinically insignificant, and the Afinion and DCA have similar accuracy and precision when used in pediatric practice settings.     

Spirometry and flow-volume curves in healthy, normal Pakistanis

Previous studies have indicated that lung volumes in healthy, normal Pakistani adults are smaller than measurements reported in comparable healthy European populations; in order to confirm these findings and to examine the relationship of maximal expiratory flow rates to lung volumes, we studied 250 non-smoking healthy subjects (116 men and 114 women) between the ages of 18 and 65 years. The population sample was drawn from urban and rural areas of Pakistan, with low levels of air pollution. The results indicate that the forced vital capacity (FVC) and forced expired volume in 1 second (FEV1) were lower in the Pakistani population compared to European populations and North American populations of European descent. These data are in conformity with previous studies; however, in Pakistani men the effects of age on FVC and FEV1 were slight so that, after the fourth decade, the FVC and FEV1 values are very comparable between the European and Pakistani populations. Amongst Pakistani women, on the other hand, FVC and FEV1 remained lower than in their European counterparts throughout adult life. Maximal expiratory flow rates amongst the men did not correlate with age, and these values were very similar to those reported in age-matched European populations. In women, however, there was a significant correlation of maximal flow rates with age and height, and the maximal expiratory flows were decreased compared to European populations. These data indicate that in Pakistani men pulmonary mechanics may be different to their European counterparts, allowing for higher maximal expiratory flows at any given lung volume.     

Accuracy and precision of hemoglobin point-of-care testing during major pediatric surgery

Introduction: The aim of the study was to compare accuracy and reproducibility of four point‐of‐care testing (POCT) devices (GEM^® Premier 3000, ABL 800 flex, GEM^®OPL^?, HemoCue^® B‐Hemoglobin) for hemoglobin (Hb) analyzes as compared with the reference laboratory method (Sysmex XE 2100) in children undergoing major surgery. Methods: Pediatric patients undergoing craniofacial, spine, hip, or cancer surgery were included. Blood samples for Hb testing were taken at several intraoperative time points and generally withdrawn from the arterial catheter, if accessible. Results: A total of 256 blood samples were taken intraoperatively from 71 pediatric patients. All POCT devices showed very small bias (maximum ?0.46 g/dL) to reference method as well as very good reproducibility (maximum coefficient of variation of 0.99%). However, in two cases (HemoCue), potential clinical relevant differences were observed beyond a range of 2 g/dL. Conclusion: All POCT devices tested and operated by trained staff for hemoglobinometry showed reliable test results. They all allow for simple, fast, and precise bedside determination of hemoglobin concentration in the intraoperative setting.