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[Reproducibility of the effectiveness of defibrillation for terminating induced ventricular fibrillation using intraoperatively measured defibrillation threshold energy in patients with implanted cardioverter-defibrillator].

The aim of the present study was to assess the long-term reproducibility of the defibrillation efficacy of energies set at the intraoperatively measured defibrillation threshold using a modified testing protocol. Between December 1993 and January 1996, 83 patients receiving an implantable cardioverter-defibrillator (ICD) in combination with a non-thoracotomy lead system and having an intraoperatively measured defibrillation threshold (DFT) < or = 15 J were enrolled in a substudy of a prospective, randomized multicenter trial ("Low Energy Endotak Trial" (LEET)). Step-down DFT testing was performed intraoperatively (15, 10, 8, 5 J). It was mandatory to reproduce a successful conversion of ventricular fibrillation at the DFT energy during implantation (DFT+). At the end of implantation, at predischarge, and after one year, assessment of the defibrillation efficacy of DFT+ energy was repeated (first shock: DFT+, second shock: 2 x DFT+). Mean DFT+ at implant was 9.6 + 3.3 J. Immediately after implantation, successful conversion of induced ventricular fibrillation was achieved in 70/79 (89%) patients using DFT+ energies. In 7/8 (89%) patients only the second shock set at 2 x DFT+ and in one patient only the third shock set at maximum energy (34 J) was successful. At predischarge, defibrillation efficacy of DFT+ was reproducible in 61/77 (79%) patients. The remaining 16 patients were successfully converted using a second shock set at 2 x DFT+. One year after implantation, conversion of ventricular fibrillation was achieved at energies set at DFT+ in 52/62 (84%) patients and in the remaining 10 patients at energies set at 2 x DFT+. A total of 183/218 (84%) episodes of induced ventricular fibrillation were terminated successfully using DFT+ energies. There was no correlation between the intraoperatively determined DFT+ or the underlying cardiac disease and the defibrillation efficacy. These results demonstrate that the defibrillation efficacy for termination of induced ventricular fibrillation using DFT+ energies is reproducible at implantation, at predischarge, and one year after ICD insertion. Energies set at twice DFT+ seems to allow for reliable defibrillation within the first year after ICD implantation.

Adult↗

High sensitivity and reproducibility of immunohistochemistry with microagitation.

We examined the practicability, reproducibility and analytical sensitivity of classical immunohistochemistry (IHC) and IHC with microagitation. Two monoclonal antibodies, Ki-67 (proliferation marker) and p53 (tumor suppressor marker), were used. Consecutive paraffin sections of biopsies of suspicious lesions of patients with non-melanoma skin cancer were used in the study. Reproducibility was examined using specimens from four patients in three independent experiments with antibodies against Ki-67 and p53. Analytical sensitivity of the two methods was determined using serial dilutions in two independent experiments. IHC with microagitation could be carried out without destroying the tissue. The new technique was consistent and reproducible, and no background staining was observed. The primary antibodies Ki-67 and p53 could be used at higher dilutions (four to ten times) with microagitation compared with classical IHC. Microagitation can be used for immunohistochemistry; it was reproducible, highly sensitive, and antibodies could be used at higher dilutions. Further analyses with other antibodies using this technique are warranted.

Biopsy↗

Reproducibility of scanning laser polarimetry (GDx) of peripapillary retinal nerve fiber layer thickness in normal subjects.

PURPOSE: To assess the reproducibility of measurement of retinal nerve fiber layer (RNFL) thickness among subjects using the GDx Nerve Fiber Analyzer (NFA). METHODS: One eye of each of five young and healthy volunteers was imaged by three newly trained technicians (R.-H.P, K.-R.K., and S.-T.K.). Each volunteer was scanned six consecutive times for five independent times within a 1-month period. One composite image was selected out of three best images per session. Intra- and interoperator reproducibilities were calculated and the influence of placement of measurement ellipse by a single operator on interobserver reproducibility was also investigated. RESULTS: Mean coefficients of variation for total integral value of RNFL were 3.67 +/- 1.47%, 3.86 +/- 2.13%, and 4.16 +/- 1.97%, respectively for the three technicians. Interoperator variability was not statistically significant (P = 0.075), and the difference was even less if a single ellipse drawn by one operator was used in all measurements (P = 0.1528) by repeated-measures analysis of variance (ANOVA). CONCLUSIONS: The results suggest that GDx NFA may provide acceptable intraoperator as well as interoperator reproducibility among Asian eyes.

Adult↗

Reproducibility of the heart rate variability responses to graded lower body negative pressure.

The reproducibility of heart rate variability (HRV) measures during graded lower body negative pressure (LBNP) have not been studied in sufficient detail. Active college age men (n=14) underwent an orientation exposure and two trials of graded LBNP to presyncope or -100 mmHg, separated by 1 week. Heart rate, stroke volume (impedance cardiography), blood pressure (Finapres), and forearm blood flow were assessed, as was HRV in both time and frequency domains. The trial-to-trial responses to LBNP common to all subjects (LBNP< or =-60 mmHg and at test termination) showed parallel changes, suggesting similar responses between both trials. Good reproducibility estimates were found for the resting HRV data (lowest: R=0.62 for low frequency/high frequency ratio; highest: R=0.94 for standard deviation of normal R-R intervals). During LBNP, reproducibility estimates varied but were generally similar to that seen at rest. At test termination, they were unacceptably low (R<0.41) for the HRV data assessed in the frequency domain and expressed in absolute units. LBNP tolerance was lower in the first trial [LBNP tolerance index: 404 (21) versus 437 (15) mmHg min(-1); P<0.05] but the intraclass correlation coefficient was high (R=0.87). These data suggest that (1) HRV responses to submaximal LBNP up to -60 mmHg are consistent across trials, (2) the considerable variability seen in the HRV parameters at maximal LBNP can be reduced by expressing these data in either the time domain or using normalized units in the frequency domain, and (3) cardiovascular responses to sub- and maximal LBNP are reproducible. Data are presented as mean (SEM) unless otherwise stated.

Adaptation, Physiological↗

The reproducibility of tolerance to lower-body negative pressure and its quantification.

The reproducibility of tolerance to lower-body negative pressure (LBNP) has not been assessed sufficiently. Furthermore, there has been confusion concerning the most appropriate index by which LBNP tolerance can be quantified. The purpose of this study was to assess the degree of reproducibility in presyncopal-symptom-limited LBNP (LBNPtol), using an LBNP chamber. Twenty physically active subjects [median age (range) 21 (18-27) years] underwent three successive LBNPtol tests with 72-120 h between each test. LBNPtol was quantified using the LBNP tolerance index (LTI; delta mmHg.min), cumulative stress index (CSI; mmHg.min), duration of negative pressure (DNP) and maximum magnitude of negative pressure (MNP). Heart rate (fc), systolic (SBP) and diastolic (DBP) blood pressures from the three repeated tests were compared during a control period. The changes from control to maximum response (fc, SBP, DBP) during LBNP were also compared, and percentage changes in estimated blood volume were measured. There were no statistical differences between any of these comparisons (P > 0.05). LTI and CSI were greater in the third test when compared to the first two tests (P < 0.05). The values for DNP and MNP were not statistically different between tests (P > 0.05). Measures of LTI and CSI showed an acceptable level of reproducibility for the first two repeated tests. However, there was an increase in LBNPtol on the third successive exposure to LBNP. These findings have shown that it is possible to achieve reproducible measures of tolerance to LBNP when using a custom-built chamber. This only applies to a test-retest procedure. Furthermore, these data also suggest that DNP and MNP do not adequately reflect the differences shown in LBNP tolerance when using LTI and CSI as measures.

Adult↗

Inter- and intraindividual reproducibility of anorectal manometry.

BACKGROUND: This study investigates the inter- and intraindividual variability of normal values and, thus, the reproducibility of anorectal manometry. MATERIALS AND METHODS: Following a standardized protocol, three anorectal manometries were performed 4 h apart on 2 days of investigation, with an interval of 4 weeks, in ten healthy volunteers. Measured parameters in all 60 manometries were: sphincter length (SL), resting pressure (RP), maximum squeeze pressure (MSP), relaxation of the internal anal sphincter (RIAS), and rectal compliance (RC). Interindividual variability was expressed as standard deviation from calculated mean values and intraindividual variability was tested with Wilcoxon's test for tied samples and Spearman's rank correlation test. RESULTS: A large interindividual variability was found for all measured parameters, except for SL, reflecting the extensive absolute range of measured values. Median intraindividual variability among the six individual measurements and between both measurement days revealed that MSP, RIAS and RC are parameters which were not reproducible in this volunteer study. A significant correlation between the results of the repetitive measurements and, thus, a good reproducibility was only found for the parameters SL and RP. CONCLUSIONS: Anorectal manometry has only limited diagnostic value; although rather exact quantifications of individual parameters can be achieved, the impact of these measurements should be regarded rather critically, since only SL and RP appeared to be reproducible parameters.

Adult↗

Reproducibility of swallowing over time in healthy elderly adults.

The purpose of this study was to evaluate the reproducibility of aspects of swallowing assessed over time by the Exeter Dysphagia Assessment Technique. Fourteen healthy elderly adults were assessed during the morning on four consecutive days. During day 1, the assessment was repeated ten times. During days 2, 3, and 4 the assessment was carried out once and at the same time of the day. This allowed the reproducibility of the data to be examined between sessions and between days. The results show that the reproducibility of data between sessions was moderate to very good for all of the items evaluated (median kappas = 0.56-0.82, ICCs = 0.7-0.8). Between-day reproducibility was also moderate to very good for nine of the variables measured (median kappas = 0.58-0.96, ICCs = 0.53-0.84) and poor for one (ICC = 0.15). We conclude that the majority of variables examined by the Exeter Dysphagia Assessment Technique are reliable when swallowing is assessed repeatedly and on different days.

Aged↗

Isometric strength measurement for muscle weakness in cancer patients: reproducibility of isometric muscle strength measurements with a hand-held pull-gauge dynamometer in cancer patients.

Our aim was to determine several indexes of reproducibility for strength measurements with a hand-held pull-gauge dynamometer (MFB50K) in cancer patients. Two independent testers performed repeated measurements of maximal isometric elbow and knee strength. The measurements were gathered in a convenience sample of 40 patients (27 men, age 20-72 years) with various types and stages of cancer. These patients were recruited from the medical oncology clinic of a university hospital. The Pearson product moment correlation coefficient, the intraclass correlation coefficient (ICC), the standard error of measurement (SEM) and its associated 95% confidence interval, the smallest detectable difference (SDD) and the limits of agreement were determined as outcome measures for reproducibility. The results for the Pearson product moment correlation and the ICC were 0.90 for elbow and 0.96 for knee extension strength. The results in terms of the SDDs were 29.4 newton (N) for elbow and 54.8 N for knee strength. The limits of agreement for elbow strength were -21.7 N and 38.5 N (mean 8.4 N). For knee strength the limits of agreement were -49.8 N and 59.8 N (mean 5 N). The Pearson product moment correlation and the ICC suggested good reproducibility. However, the more informative indices of reproducibility, i.e. the SEM and the SDD, showed relatively large measurement error between the testers. Therefore, the current use of the MFB50K for the measurement of muscle strength is not supported in cancer patients.

Adult↗

Reproducibility of a low back pain questionnaire in Tunisian adolescents.

The objective of this study was to evaluate the reproducibility of a 28-item survey questionnaire for back problems in Tunisian adolescents. A test-retest design was used to investigate the reproducibility of the results obtained using the said 28-item survey questionnaire. Participants were recruited from two schools in Monastir. Seventy-two adolescents from the seventh, eighth, and the ninth grade participated in the inquiry. They have a mean age of 14.01 years (SD 1.67, range 11-19). High levels of reproducibility were found for items that evaluated perceived characteristics of back problems and functional limitation (kappa coefficient=0.71-1.00). The results suggest that the questionnaire used in the present study provided reproducible information and can be used as a survey tool for the investigation of low back problems in adolescents.

Activities of Daily Living↗

Assessment of intercentre reproducibility and epidemiological concordance of Legionella pneumophila serogroup 1 genotyping by amplified fragment length polymorphism analysis.

The aims of this work were to assess (i) the intercentre reproducibility and epidemiological concordance of amplified fragment length polymorphism analysis for epidemiological typing of Legionella pneumophila serogroup 1, and (ii) the suitability of the method for standardisation and implementation by members of the European Working Group on Legionella Infections. Fifty coded isolates comprising two panels of well-characterised strains, a "reproducibility" panel (n=20) and an "epidemiologically related" panel (n=30), were sent to 13 centres in 12 European countries. Analysis was undertaken in each centre following a previously determined standard protocol. Results were analysed by the participants, using gel analysis software where available, and submitted to the coordinating centre. The coordinating centre reanalysed all results visually and selected data-sets with gel analysis software. Data analysis by participants yielded reproducibility (R) values of 0.20-1.00 and epidemiological concordance (E) values of 0.11-1.00, with 6 to 34 types. Following visual analysis by the coordinating centre, R=0.78-1.00, and E=0.67-1.00, with 10-20 types. Analysis of three data-sets by the coordinating centre using gel analysis software yielded R=1.00 and E=1.00, with 12, 13 or 14 types. This method can be used as a simple, rapid screening tool for epidemiological typing of isolates of Legionella pneumophila serogroup 1. Results demonstrate that the method can be highly reproducible (R=1.00) and epidemiologically concordant (E=1.00), with good discrimination. The electropherograms generated are amenable to computer-aided analysis, but strict adherence to a previously defined laboratory protocol is required. Following designation of representative type strains and patterns, this method will be adopted by the European Working Group on Legionella Infections as the first internationally standardised typing method for use in the investigation of travel-associated Legionella infections.

DNA, Bacterial↗

Reproducibility of heart rate and blood pressure variability in patients with chronic obstructive pulmonary disease.

Wide variations in respiratory rate and hypoxic stimulation of chemoreceptors may produce unreliable autonomic results in patients with COPD. We studied the reproducibility of two consecutive measurements of heart rate variability (HRV) and blood pressure variability (BPV) by time frequency analysis in patients with COPD while controlling respiratory rate and oxygen hemoglobin saturation (SaO(2)). Reproducibility was assessed by paired t-tests and correlation analyses between repeated measures. Correlation analyses of the log transformed low (LF) and high frequency (HF) HRV were x 11.5 +/- 1.1 in measurement A and x 11.5 +/- 1.0 in measurement B (r = 0.89, p < 0.0001), and x 10.5 +/- 1.1 in measurement A and x 10.6 +/- 1.1 in measurement B (r = 0.89, p < 0.0001) respectively. The log transformed LF and HF BPV were x 4.9 +/- 1.3 in measurement A and x 5.3 +/- 0.9 in measurement B (r = 0.70, p < 0.0002), and x 6.4 +/- 1.3 in measurement A and 6.6 +/- 1.2 in measurement B (R = 0.71 p < 0.0001) respectively. In conclusion, time frequency analysis of HRV and BPV is reproducible and reliable in patients with COPD while controlling their respiratory rate and oxygen hemoglobin saturation. Reproducibility of these measurements may allow for a non-invasive evaluation of autonomic tone in response to treatments in COPD patients.

Aged↗

Routine breath-hold gradient echo MRI-derived right ventricular mass, volumes and function: accuracy, reproducibility and coherence study.

Right ventricular (RV) dysfunction is a predictor of poor outcome in patients with heart disease. Conventional imaging modalities fail to assess RV volumes accurately. We sought to assess the accuracy and reproducibility of routine breath-hold gradient echo magnetic resonance imaging (MRI)-derived RV mass, volumes and function. We assessed: (1) The accuracy of in vivo MRI-derived RV mass in comparison to the RV weight in 9 minipigs. (2) Intra- and inter-observer reproducibility of RV mass, end-diastolic (EDV) and end-systolic (ESV) volumes and ejection fraction (EF) in 15 normal volunteers and 10 patients with heart disease. (3) Inter-study reproducibility of the former parameters in 25 coronary artery disease patients. (4) The correlation between right and left ventricular stroke volumes in the total population. Strong statistically significant correlations were found between: (1) MRI-derived RV mass and RV weight (r = 0.98, bias = 2.5 g), (2) Intra-observer measurements of RV mass (r = 0.96, bias = 0.5 g), EDV (r = 0.99, bias = -1.5 ml), ESV (r = 0.98, bias = 0.1 ml) and EF (r = 0.92, bias = -1.4%), (3) Inter-observer measurements of RV mass (r = 0.95, bias = 1.1 g), EDV (r = 0.98, bias = -1.1 ml), ESV (r = 0.98, bias = 1.2 ml) and EF (r = 0.87, bias = -1.9%), (4) Inter-study measurements of RV mass (r = 0.91, bias = -0.1 g), EDV (r = 0.96, bias = 3.8 ml), ESV (r = 0.98, bias = 0.3 ml) and EF (r = 0.90, bias = 0.9%), (5) MRI-derived right and left ventricular stroke volumes (r = 0.87). The assessment of the RV mass, volumes and function by routine breath-hold gradient echo MRI is accurate and highly reproducible. The correlation between left and RV MRI-derived stroke volumes indicates excellent coherence of simultaneous bi-ventricular volume measurements.

Adult↗

Reproducibility of a comprehensive diet history in the Diabetes Control and Complications Trial. The DCCT Research Group.

OBJECTIVE: To evaluate the reproducibility of a modified Burke-type diet history within the context of a long-term, randomized, 29-center clinical diabetes study. DESIGN: Diet histories were collected by trained interviewers at the end of years 1 and 2 after subjects were randomly assigned to the intensive treatment group or the conventional treatment group. Mean daily intakes of energy, protein, carbohydrate, total fat, saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, cholesterol, and dietary fiber were calculated for each treatment group at each time period. SUBJECTS: The study population consisted of 139 subjects in the intensive treatment group and 128 subjects in the conventional treatment group. Ages ranged from 13 to 39 years; groups included men and women. Distribution by age, sex, race, proportion of smokers, weight reported as percent ideal body weight, and duration of IDDM were similar in both groups. STATISTICAL METHODS: Differences in nutrient intake between the conventional and intensive treatment groups at each time period were tested for significance using the Wilcoxon rank-sum test. The Wilcoxon paired differences test was used to assess changes between time periods within treatment groups. Linear agreement between repeated administrations of the diet history was evaluated using Pearson's correlation coefficient, and the extent of within-subject reproducibility was assessed by intraclass correlation. RESULTS: No statistically significant differences in energy and nutrient intakes were observed between the two groups at either year 1 or year 2. Within each treatment group, energy and nutrient intake differences between times were not statistically significant. Correlation coefficients between years 1 and 2 ranged from .51 for dietary fiber to .72 for dietary cholesterol; within-subject reproducibility was slightly higher. APPLICATIONS: These results demonstrate long-term reproducibility for the meal-based diet history in the DCCT population.

Adolescent↗

Reproducibility of programmed electrical stimulation responses in patients with ventricular tachycardia or fibrillation associated with coronary artery disease.

Invasive electrophysiologic studies were performed in 102 patients with sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) using an aggressive programmed electrical stimulation (PES) protocol. The study was repeated after 2.0 +/- 2.9 days in all patients with no intercurrent changes in antiarrhythmic therapy. Patients with coronary artery disease (n = 72) were identified and PES results of these patients were analyzed and compared with results of patients without coronary artery disease. Multiple clinical and electrophysiologic factors were analyzed to determine any association with concordance of PES responses. No significant difference in concordance of PES responses was found in the 2 groups of patients. PES responses were groups into 3 categories: (1) noninducible, (2) nonsustained VT, and (3) sustained VT. Kappa values of PES responses of noninducible and sustained VT in both groups were higher and therefore the PES responses were more reproducible than nonsustained VT. The induction of sustained monomorphic VT was more reproducible than a PES response of nonsustained or sustained polymorphic VT. Inducible sustained VT with a rate of greater than or equal to 250 beats/min was less reproducible than induction of sustained VT with a rate less than 250 beats/min. Induction of VT by 3 extrastimuli was less reproducible than with any other mode. This short-term variability may account for false negatives associated with PES-directed antiarrhythmic therapy. Because of these findings, it is recommended that nonsustained VT and sustained polymorphic or rapid polymorphic VT should not be used as PES end points to guide antiarrhythmic therapy.

Anti-Arrhythmia Agents↗

Reproducibility of stress redistribution thallium-201 SPECT quantitative indexes of hypoperfused myocardium secondary to coronary artery disease.

To determine the reproducibility of quantitative indexes of hypoperfused myocardium by exercise thallium-201 single-photon emission computed tomography, duplicate studies were performed in 16 stable patients within 1 month. Twenty-three other patients, with intervals up to 13 months between studies, were retrospectively identified from medical records. Symptoms, weight, heart rate achieved and peak systolic blood pressure during the 2 studies were similar. Maximal counts circumferential profiles' polar maps were generated and divided into 3 vascular territories. The hypoperfused myocardium was defined as the percent stress profile points below the normal level. The observed values were compared between the 2 studies for each patient. Defect size ranged from 0 to 73%. The concordance correlation coefficient (a measure of the closeness of the data points to the line of identity) and mean absolute deviation were 0.94 and 4.5%, respectively, when all patients were considered together, 0.93 and 3.2%, respectively in the reproducibility group, and 0.94 and 5.1%, respectively, in the retrospective group. Inter- and intraobserver reproducibility were also very high. For individual vessels, the concordance correlation coefficients were all > or = 0.89 and the mean absolute deviations between 3.7 and 9%. Thus, in stable patients with repeat thallium studies within a year, the percent hypoperfused myocardium is highly reproducible.

Adult↗

Prospective evaluation of day-to-day reproducibility of upright tilt-table testing in unexplained syncope.

To evaluate the day-to-day reproducibility of upright tilt-table testing, 109 patients with unexplained syncope prospectively underwent testing on 2 consecutive days using a uniform protocol. Results of testing on 2 separate days were concordant in 69 of 109 patients (63%), and discordant in 40 of 109 patients (37%). Thirty-six of 109 patients (33%) had vasodepressor syncope on 1 or both days of testing. Nineteen of 30 patients (63%) with vasodepressor responses on the first day did not reproduce this response during the second day of testing. An additional 6 patients with an initial negative tilt test had a vasodepressor response on the second day. Only 11 of 36 patients (31%) had reproducible vasodepressor responses on both days of testing. Patients with reproducible vasodepressor responses had a significantly higher mean number of preceding clinical syncopal events than patients with 2 normal tests (p < 0.02) or nonreproducible results (p < 0.04). In addition, these patients had a significantly longer duration of clinical symptoms relative to patients with 2 tests that yielded negative results (p < 0.008) and nonreproducible results (p < 0.01). The elapsed time between the most recent clinical event and the performance of tilt-table testing was not significantly different among the 3 groups, and did not appear to influence the outcome of testing. These data show that vasodepressor responses elicited by upright tilt-table testing show day-to-day variability in many patients, a finding that may limit the interpretation of initial and follow-up test results.

Adult↗

Reproducibility of long-term ambulatory esophageal combined pH/manometry.

Long-term ambulatory esophageal manometry is used increasingly, but normal values and data on the reproducibility of the method are not available. Thus, studies were conducted using paired 24-hour recordings, separated by 1-4 weeks, in 24 healthy volunteers (aged 19-50). Computerized analysis of each two-channel pressure recording (5 and 15 cm above lower esophageal sphincter) determined mean contraction amplitude, duration, area under the curve, contractility and propagation velocity, and the proportion of propagated contractions during day and night periods. A combined glass pH electrode (5 cm above lower esophageal sphincter) was used to register acid reflux. Visual analysis of the 24-hour contractility patterns showed marked intraindividual reproducibility but, although most subjects showed similar meal-associated increases and sleep-associated decreases in contraction frequency and amplitude, considerable interindividual variation was observed. This was confirmed by comparing the variation between subjects in the first and second recordings with the variation between recordings in the same subject; for all pH and manometry variables, the coefficient of variation was two to three times greater between subjects than between recordings in the same subject. The recordings were highly reproducible within subjects (nighttime contraction duration, P less than 0.05; all other variables, P less than 0.01). Thus, computerized ambulatory pH manometry is reproducible and because healthy volunteers have a characteristic individual pattern of esophageal motility, the method is perfectly suitable for repeated-measure design physiological and pharmacological studies. However, generally applicable normal values are difficult to define.

Adult↗

Reproducibility of one-stage, two-stage and chromogenic assays of factor VIII activity: a multi-center study.

This study was aimed at assessing the reproducibility of Factor VIII assays between different laboratories using the same reagents. A total of 176 post-dose plasma samples were obtained from 8 Italian subjects with hemophilia-A treated with a single dose of Factor VIII concentrates. Three laboratories (in FRG, Italy, and Sweden) participated in the study. Frozen aliquots of each sample were dispatched to each of the laboratories, where the aliquots were assayed using the same one-stage, two-stage and chromogenic methods. The one-stage and the chromogenic methods were well reproducible between the three centers: pairwise correlation analyses yielded r-values ranging from 0.88 to 0.91 for the one-stage method and from 0.91 to 0.96 for the chromogenic method. The agreement between these two assays was less evident in samples with activity below 200 IU/L in which the one-stage gave, on average, higher Factor VIII concentrations than those provided by the chromogenic method. The two-stage method was not well reproducible, and the pairwise r-values ranged from 0.48 to 0.73. Our study emphasises the need to develop multi-center quality control programs to verify the reproducibility of Factor VIII assays.

Adolescent↗