Prospects for automated differential leucocyte counting in the routine laboratory.
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Automation↗
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Results for “Automation, Laboratory”
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An integrated system for the automation of the clinical chemistry laboratory.
A user programmable microcomputer-based integrated system for automatic analysis in the clinical chemistry laboratory is presented. Friendly user-instrument interaction helps the operator when defining tests and analytical conditions or entering sample data and test requests. Quality control data are retained for the automatic production of various statistical lists and graphs. Routine operator intervention is limited to reagent preparation, sample loading onto the autosampler plate, definition of the tests to be performed on each of the samples and data validation before the generation of reports. Finally, connection with an existing laboratory management system is provided by means of a standard serial interface.
Automation↗
Comparison of five automated serum and whole blood folate assays.
Serum and whole blood folate measurements are used to establish folate deficiency. Most methods used in clinical laboratories are automated, nonistopic methods that use folate-binding protein. Linearity, imprecision, and method comparison studies, including serum and whole blood hemolysates, were performed with the Access, Advia Centaur, ARCHITECT i2000, Elecsys 2010, and IMMULITE 2000 methods. The QuantaPhase II radioassay served as the comparison method. (Proprietary information is given in the text.) The Access and IMMULITE 2000 methods had higher systematic errors in linearity studies than the other 3 methods. The imprecision of all methods was acceptable (coefficient of variation, < 10%) even at low folate concentrations with the exception of the Elecsys 2010 (coefficient of variation, 16%). Method comparison studies using serum samples revealed calibration differences between the Access and Elecsys 2010 methods and the comparison method. Method comparison studies using whole blood samples showed poorer agreement between each of the automated methods and the comparison method than was seen with serum samples. The ARCHITECT i2000 folate assay demonstrated the best analytic performance. The poor agreement seen with whole blood hemolysates likely is due to calibration differences and differences in hemolysate preparation conditions.
Blood Chemical Analysis↗
[Laboratory evaluation for urine identification card in the automated microbial system (author's transl)].
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Automation↗
Three assays for glycohemoglobin compared.
Using 123 specimens, we compared the concordance of three different methods for determining glycohemoglobin (GHb): the Diamat (Bio-Rad Laboratories), an automated analyzer measuring HbA1c by cation-exchange chromatography; an assay with the IMx analyzer (Abbott Laboratories), based on boronate affinity binding; and an HPLC method measuring HbA1c by cation-exchange chromatography on a PolyCAT A column (PolyLC Inc.). The Pearson's correlation coefficient between PolyCAT A and Diamat was 0.900 +/- 0.038 (mean +/- 2 SD) and between PolyCAT A and IMx, 0.857 +/- 0.042. However, up to twofold differences were seen in some samples. The proportion of GHb was consistently lower with the PolyCAT A method than with the other two assays, apparently because of better separation of HbA1c from nonglycated coeluting forms of Hb. The difference in glycation percentage between the PolyCAT A and Diamat methods is 2-3% over the whole concentration range. These results point to the limitations of Diamat as a reference method to be used to calibrate other methods for determining HbA1c. Further, a switch from one method to another is likely to cause considerable problems in the clinical follow-up of certain patients.
Autoanalysis↗
Use of the Terumo SteriCell for the processing of bone marrow and peripheral blood stem cells.
The SteriCell cell processing instrument is a good choice for a stem cell processing laboratory that is of sufficient size that they cannot share an apheresis machine with the blood bank. It is a laboratory instrument, with no facility for patient connection. Because of its minimal size and weight, it is easily stored in a cramped laboratory. Its automated programs are appropriate for processing of bone marrow and peripheral blood stem cells, and it is quite easy to learn how to use (in our laboratory, most individuals have been completely facile with the SteriCell after fewer than six processings). Based on reported results from other instruments, the SteriCell provides cell yields that are comparable to competing instruments. Service (provided by Haemonetics) has been satisfactory, and support from Terumo has been excellent. We can recommend this instrument to any other laboratory.
Automation↗
Automation in the blood transfusion laboratory. 3. Use of the autoanalyzer in a prenatal consultation program.
A Technicon AutoAnalyzer hemagglutination system was used to test sera from 1388 prenatal patients. This automated approach to antibody screening was slightly more successful than careful hand tests. Estimates of anti-D concentration on the AutoAnalyzer correlated well with antiglobulin titres and compared favourably with hand titres in indicating those cases requiring examination of amniotic fluid. Once other large-scale studies establish what levels of anti-D are clinically significant, apparatus of the type described should be of considerable practical value in routine prenatal work.
Amniotic Fluid↗
[Idea and practice with the systematization of clinical laboratory in the Central Laboratory, Osaka University Hospital].
On 1 September 1993, we left our old hospital and moved to our brand new establishment, and at that time we adopted the order-entry and reporting system. In this paper we report on our new laboratory computer system that has been developed to manage a lot of information and to analyze rapidly many test tubes (4000 samples per day) and to elevate the service for our patients. We developed the automated clinical laboratory system and this new system was named as the Clinical Laboratory Supervised System (CLASSY). We used the NEC system 3500 Model 10, NEC N5200 Model 03 sx and NEC PC9821 Ae as a laboratory host computer, an interface unit and a terminal for routine work, respectively. CLASSY covers the automated analysis not only for clinical chemistry, but also for hematology, urinalysis and microbiology. As the ordering and reporting system is applied to the hospital information system, order information for clinical test is transferred to our laboratory host computer when the bar-code label is printed out from the automatic bar-code labeller. Then it is transferred from the laboratory host computer to some subsystems or automatically to an analyzer through the interface units or modems.
Clinical Laboratory Information Systems↗
E-health, phase two: the imperative to integrate process automation with communication automation for large clinical reference laboratories.
The initial efforts of e-health have fallen far short of expectations. They were buoyed by the hype and excitement of the Internet craze but limited by their lack of understanding of important market and environmental factors. E-health now recognizes that legacy systems and processes are important, that there is a technology adoption process that needs to be followed, and that demonstrable value drives adoption. Initial e-health transaction solutions have targeted mostly low-cost problems. These solutions invariably are difficult to integrate into existing systems, typically requiring manual interfacing to supported processes. This limitation in particular makes them unworkable for large volume providers. To meet the needs of these providers, e-health companies must rethink their approaches, appropriately applying technology to seamlessly integrate all steps into existing business functions. E-automation is a transaction technology that automates steps, integration of steps, and information communication demands, resulting in comprehensive automation of entire business functions. We applied e-automation to create a billing management solution for clinical reference laboratories. Large volume, onerous regulations, small margins, and only indirect access to patients challenge large laboratories' billing departments. Couple these problems with outmoded, largely manual systems and it becomes apparent why most laboratory billing departments are in crisis. Our approach has been to focus on the most significant and costly problems in billing: errors, compliance, and system maintenance and management. The core of the design relies on conditional processing, a "universal" communications interface, and ASP technologies. The result is comprehensive automation of all routine processes, driving out errors and costs. Additionally, compliance management and billing system support and management costs are dramatically reduced. The implications of e-automated processes can extend beyond the specific transaction problems they are designed to solve. The ready access and communication of process details required by e-automation can apply to many other business functions.
Accounts Payable and Receivable↗
Sample preparation for the HPLC analysis of drugs in biological fluids.
Sample preparation for the analysis of drugs in biological fluids consists of a number of unit operations that are used for (i) release of the drug from a conjugate or biological matrix; (ii) removal of endogenous compounds that could interfere with the assay; and (iii) techniques for liquid handling. The trends in sample preparation that have occurred over the past 10 years in the authors' laboratory are discussed. In general, there has been a move from the traditional liquid-liquid extraction to methods using bonded-silica which permit rapid throughput and efficient extraction. Automation of sample preparation has seen further gains in productivity; however, the present generation of equipment lack the control and communication systems that are essential for the development of the automated integrated laboratory of the future.
Automation↗
Evaluation of a community-based automated blood pressure measuring device.
BACKGROUND: Automated devices are widely available in the community for people to measure their blood pressure. We assessed the accuracy and reproducibility of a brand of community-based automated device against the standard mercury sphygmomanometer. METHODS: Same-arm pairs of blood pressure readings were obtained with the Vita-Stat 90550 automated device, a sphygmomanometer and the Omron HEM-705CP automated device in random order on volunteers in 3 community pharmacies using a modified protocol for evaluating blood pressure devices. Comparison of readings between the Omron device and the sphygmomanometer served as a positive control of how well a laboratory-validated automated device could perform in the community. Both the Association for the Advancement of Medical Instrumentation (AAMI) and British Hypertension Society (BHS) criteria were used to assess the accuracy and reproducibility of readings. RESULTS: The mean blood pressure reading and standard error (SE) of the mean for the 108 volunteers (66 women and 42 men) was 133/77 (SE 2/1) mm Hg with the Vita-Stat device, 131/77 (SE 2/1) mm Hg with the Omron device and 129/76 (SE 2/1) mm Hg with the sphygmomanometer. The mean difference in readings was 4.4/1.0 (standard deviation [SD] 9.4/6.2) mm Hg between the Vita-Stat device and the sphygmomanometer and 1.6/0.6 (SD 9.3/6.4) mm Hg between the Omron device and the sphygmomanometer. Neither automated device met the AAMI accuracy criteria for the systolic readings. The BHS grades were C/A (systolic unacceptable/diastolic acceptable) for each automated device. According to the BHS analytical criterion, all devices achieved acceptable reproducibility grades. INTERPRETATION: Neither automated device met the AAMI or BHS criteria for accuracy while in use in the community, and neither performed as well in the community as in the laboratory.
Adult↗
Laboratory evaluation of a fully automated chemiluminescence immunoassay for rapid detection of HBsAg, antibodies to HBsAg, and antibodies to hepatitis C virus.
The performance of a fully automated, random access, enhanced chemiluminescence immunoassay (Ortho/ECi) for the detection of antibody to hepatitis C virus (HCV) (anti-HCV), HBsAg, and antibody to HBsAg (anti-HBsAg), in human serum was compared to a Abbott second-generation enzyme immunoassay (EIA 2.0). The Ortho/ECi assays employ an immunometric technique with enhanced chemiluminescence for optimal assay performance. With regard to the study of clinical laboratory performance, six groups of sera prescreened with Abbott EIAs were assayed: anti-HCV-negative samples (n = 318), anti-HCV-positive samples (n = 177), anti-HBsAg-negative samples (n = 241), anti-HBsAg-positive samples (n = 239), HBsAg-positive samples (n = 158), and HBsAg-negative samples (n = 312). Sera with discrepant results in the two serological assays were resolved by confirmatory tests. Sera with indeterminate results by one or more confirmatory tests were evaluated by reviewing medical records. The overall concordance between the Ortho/ECi assay and the Abbott EIA were 97.78, 93.54, and 97.66% for anti-HCV antibodies, anti-HBsAg antibodies, and HBsAg, respectively. After resolving the discrepancies, the specificities of the new assay for anti-HCV and anti-HBsAg antibodies and HBsAg were 98.1, 92.8, and 100%, respectively. The sensitivities of the new assay for anti-HCV, anti-HBsAg, and HBsAg were 100, 98.8, and 97.4%, respectively. In conclusion, The Ortho/ECi assays for diagnosis of HCV and hepatitis B virus (HBV) infections are highly specific and sensitive assays. The rapid turnaround time, random access, full automation, and high throughput make it an effective assay system for clinical laboratory diagnosis of HCV and HBV infections.
Automation↗
[Prospects for automating the basic groups of physiochemical laboratory research methods].
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Automation↗
Evaluation of a covalent mix-enzyme linked immunosorbent assay for screening of Salmonella antibodies in pig serum.
In this study, a commercial Salmonella covalent mix-enzyme linked immunosorbent assay (ELISA) for serological detection of Salmonella infection in swine was evaluated by comparing it with the conventional fecal culture method and inter-laboratory proficiency testing, using a panel of sera tested in 5 laboratories from Europe and North America. Comparison with culture results showed that 88.5% of 26 culture-positive animals were ELISA positive, as were 55% of 60 animals from 2 culture-positive pig herds. Of 90 animals from 2 high health farms with no clinical symptoms of salmonellosis, 98.9% tested negative. The interlaboratory comparison study found a kappa value of 0.9 between our laboratory (using an automated system) and the manufacturer laboratory (using the manual method). Comparison of ELISA results from all 5 participating laboratories showed very good to excellent agreement, between 85% and 97.5%. We found this assay to be useful for the screening of antibodies against Salmonella present in swine serum. It agrees well with bacterial cultures, is reproducible, sensitive, specific, repeatable, and suitable for automation.
Animals↗
Automation in the blood transfusion laboratory. II. ABO grouping, Rh and Kell typing, antibody screening, and VD testing of blood donations in the autoanalyzer.
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ABO Blood-Group System↗
Comparison of the Abbott IMx and a high-performance liquid chromatography method for measuring total plasma homocysteine.
The determination of the total concentration of plasma homocysteine is of interest in a variety of clinical circumstances, especially, in the evaluation of the risk of cardiovascular disease. However, most of the methods available to date, many of them chromatographic, are not well suited for the majority of clinical laboratories. Several automated methods are now or will be, shortly, commercially available. We have compared one of them, the fluorescence polarization immunoassay (FPIA) adapted to the IMx analyzer (Abbott Laboratories), with the high-performance liquid chromatography (HPLC) method with fluorescent detection currently used in our laboratory. The results show that the FPIA-IMx method is less imprecise and slightly more sensitive than the HPLC. The comparison of 67 clinical plasma specimens indicated that there is a proportional error disagreement between FPIA-IMx and HPLC (FPIA=1.19 HPLC + 0.92; confidence region for slope and y-intercept were, respectively, from 1.06 to 1.31 and from -0.06 to 2.32). The nature of this error is not explained by the experiments performed to study the inaccuracy of both methods, which included the investigation of dilution parallelism, analytical recovery and cross-reactivity. The different results of homocysteine concentration obtained with FPIA-IMx and HPLC must be taken into account when a change of methodology is under consideration.
Chromatography, High Pressure Liquid↗
A comparative analysis of physiological responses at submaximal workloads during different laboratory simulations of field cycling.
The purpose of this study was to evaluate the relationships between heart rate (fc), oxygen consumption (VO2), peak force and average force developed at the crank in response to submaximal exercise employing a racing bicycle which was attached to an ergometer (RE), ridden on a treadmill (TC) and ridden on a 400-m track (FC). Eight male trained competitive cyclists rode at three pre-determined work intensities set at a proportion of their maximal oxygen consumption (VO2max): (1) below lactate threshold [work load that produces a VO2 which is 10% less than the lactate threshold VO2 (sub-LT)], (2) lactate threshold VO2 (LT), and (3) above lactate threshold [workload that produces a VO2 which is 10% greater than lactate threshold VO2 (supra-LT)], and equated across exercise modes on the basis of fc. Voltage signals from the crank arm were recorded as FM signals for subsequent representation of peak and average force. Open circuit VO2 measurements were done in the field by Douglas bag gas collection and in the laboratory by automated gas collection and analysis. fc was recorded with a telemeter (Polar Electro Sport Tester, PE3000). Significant differences (P < 0.05) were observed: (1) in VO2 between FC and both laboratory conditions at sub-LT intensity and LT intensities, (2) in peak force between FC and TC at sub-LT intensity, (3) in average force between FC and RE at sub-LT. No significant differences were demonstrated at supra-LT intensity for VO2. Similarly no significant differences were observed in peak and average force for either LT or supra-LT intensities. These data indicate that equating work intensities on the basis of fc measured in laboratory conditions would overestimate the VO2 which would be generated in the field and conversely, that using fc measured in the laboratory to establish field work intensity would underestimate mechanical workload experienced in the field.
Adult↗
Measurement of apolipoprotein B-containing lipoproteins for routine clinical laboratory use in cardiovascular disease.
Although research studies, using complex methods, have shown apolipoprotein B level to be a better marker for coronary artery disease than cholesterol level, it is unclear whether apolipoprotein B level can perform as well when measured by automated clinical laboratory kit methods. The purpose of this study was to determine whether apolipoprotein B level assayed by a kit method is a better marker for coronary artery disease than low-density lipoprotein and total cholesterol levels in patients presenting for angiography. The subjects were two groups of male patients, 44 to 70 years old: 139 with disease and 41 without. Apolipoprotein B level differentiated more than 20-fold better than total or low-density lipoprotein cholesterol levels between the medians of the two groups and showed better diagnostic sensitivity and better diagnostic specificity than total and low-density lipoprotein cholesterol levels. Triglyceride levels were highly significant but showed poorer diagnostic sensitivity than apolipoprotein B level. We conclude that apolipoprotein B level is a more effective marker for coronary artery disease than low-density lipoprotein or total cholesterol levels.
Adult↗