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PubMedDate not supplied

Microcomputer applications in biomedical research.

Microprocessors and microcomputers are assuming an increasingly important role in clinical and biomedical research. They are applied to the development of new devices for monitoring patients, replacing lost physiologic or sensory function, or performing therapeutic procedures. In research laboratories, microprocessors help to automate instrumentation for measurement and control and to control data collection and analysis functions. Several applications from the National Institutes of Health described by the author illustrate some of these uses.

Computers↗
PubMed1989

[Increasing effectiveness of the use of laboratory data in the therapeutic-diagnostic process through automatization].

Introduction of the complex computer-aided mechanization and automatization into the laboratory process and their integration with other automated information hospital systems significantly raise efficacy of laboratory data application in treatment and diagnosis, thus reducing work losses of the medical staff. The structure of biochemical research for clinical therapeutic and surgical departments is presented along with the main biochemical diagnostic programmes for some diseases.

Diagnosis, Computer-Assisted↗
PubMed2005

Evaluation of the BD Phoenix SMIC/ID, a new streptococci identification and antimicrobial susceptibility panel, for potential routine use in a university-based clinical microbiology laboratory.

We evaluated the new BD Phoenix automated microbiology system (Becton Dickinson Diagnostic Systems, Sparks, MD) SMIC/ID-4 panel for routine identification (ID) and antimicrobial susceptibility testing (AST) of streptococci in a university-based laboratory. Clinical isolates of Streptococcus pneumoniae (n = 92), Streptococcus pyogenes (n = 24), and Streptococcus agalactiae (n = 10) were collected, and comparisons were made with the routine manual methods used in our microbiology laboratory for ID and susceptibility testing. ID concordance with manual methods was 85.9%, 95.8%, and 90.0% for S. pneumoniae, S. pyogenes, and S. agalactiae, respectively. With respect to AST concordance for S. pneumoniae and beta-hemolytic streptococci (S. pyogenes and S. agalactiae) using Phoenix and standard broth microdilution panels, overall essential agreement was 93.0% and 97.5%, respectively, whereas overall category agreement was 92.4% and 98.9%, respectively. Major and minor error rates for S. pneumoniae and beta-hemolytic streptococci were 0.5% and 0.3%, and 7.1% and 0.8%, respectively. Very major errors were not observed in this study. Mean time for ID and AST test completion was 13.6 +/- 1.6, 10.7 +/- 2.4, and 11.2 +/- 2.3 h for S. pneumoniae, S. pyogenes, and S. agalactiae, respectively. We have demonstrated that Phoenix ID results show high agreement with manual ID and that AST performance was equivalent to standard broth microdilution in less time.

Anti-Bacterial Agents↗
PubMed1991

Chromogenic peptide substrate assays and their clinical applications.

Chromogenic peptide substrates were first introduced into research laboratories in the early 1970s and were quickly utilised to develop assays for the determination of enzymes, proenzymes and inhibitors of the coagulation system. These assays were gradually introduced into coagulation and clinical chemistry laboratories as laboratory tools in the diagnosis and treatment of coagulation disorders. From the knowledge of the structures of the natural substrates attacked by enzymes other than those of the coagulation system or by synthesis and random screening, substrates for enzymes of the fibrinolytic, plasma and glandular kallikrein and complement systems were produced. These allowed various research groups to develop assays for components of these systems and subsequently led to the use of these assays in studies on various clinical conditions. Substrates for activated protein C ensured that assays for this enzyme and its inhibitors could be developed and introduced into the haematological routine. With the introduction of substrates for limulus lysate not only were assays for endotoxins in clinical samples produced but the control of all disposable products and injectables for endotoxin contamination can now be effected. Initially high costs and time-consuming manual assays were a hinderence to the general acceptance of the use of chromogenic peptide substrate assays and they were only used routinely in a few specialised laboratories. With the introduction of automated and microtitre plate methods however, these assays are are now available in most hospital laboratories. Since the first chromogenic peptide substrate was described thousands of articles have been published on the use of chromogenic substrate assays to measure proenzymes, enzyme activators, enzyme cofactors and inhibitors in blood and other body fluids in normal subjects and clinical material. We have endeavoured to cover as many of these as possible in this review.

Blood Chemical Analysis↗
PubMed1993

Method comparison of EMIT II and online with RIA for drug screening.

The newest formulation of the EMIT assay for drugs of abuse, EMIT II, and a new immunoassay, OnLine, using the kinetic interaction of microparticles in solution methodology, were evaluated for marijuana, cocaine, opiates, barbiturates, and phencyclidine. Both types of immunoassays were performed on an Hitachi 717 analyzer. Calibration curves, the degree of separation between negative and cutoff calibrators, precision, probability of carryover from positive to negative samples, and overall ease and speed of analysis were evaluated. EMIT II and OnLine were compared with RIA tests for the five drugs to determine each assay's ability to detect samples which confirm positive by GC/MS. The RIA and OnLine marijuana tests detected > 99% of confirmed positive samples while EMIT II detected about 90%. All three immunoassays performed equivalently for cocaine and opiates, each assay detecting at least 98% of positives. Barbiturates showed the greatest disparity with OnLine detecting 96%, EMIT II 85%, and RIA 79% of confirmed positive samples. Too few phencyclidine positive samples were detected for a method comparison study. The fully automated EMIT II and OnLine assays are preferable for a variety of reasons to our laboratory's current semi-automated RIA tests for large volume urine testing. The immunoassays offer comparable performance for some drugs but not for others.

Calibration↗
PubMedDate not supplied

Bayesian analysis: an objective, scientific approach to better decisions.

An important responsibility for managers is to see that good decisions are made, which includes training other decision makers in how to make them. In our rapidly changing health-care environment, it is important that the best decisions be made based on cost-effectiveness (tests we perform or outsource), productivity (employees we hire), service quality (how we organize services), technology (equipment and methods we purchase), and outcomes (what we accomplish for patients). A decision analysis method is described that uses an objective, scientific approach to decision making. Bayesian analysis is a statistical method that allows researchers (decision makers) to take into account data as well as prior beliefs to calculate the probability that an alternative (decision, treatment) is superior. Developing criteria, prior rating, of options, and calculating assessments and final assessment are included in the analysis. An example is provided to show how our laboratory compared routine hematology automation alternatives (automated cell counter, automated microscope, and automated flow cytometry cell counter) using the Bayesian analytical technique. Discussion follows related to how the technique is effective in managing team decisions by allowing different opinions, past experiences, and beliefs to be expressed and evaluated.

Bayes Theorem↗
PubMed1982

Prevalence of hyperlipidemia in a large sample population.

In recent times, increasing attention has been focused on serum lipid levels as a risk factor for coronary heart disease. With an extremely large data base available at Metpath clinical laboratory--more than 3 million cholesterol and triglyceride determinations, and over 500,000 high-density lipoprotein (HDL) cholesterol analyses performed yearly on ambulatory asymptomatic and symptomatic individuals seen by primary care office-based physicians in the United States--an investigation was undertaken to provide a clear indication of the actual prevalence of hyperlipidemia in this country. All lipid measurements were performed routinely by standard automated procedures at one laboratory site, and the test results were analyzed statistically. Computer analysis clearly shows that hyperlipidemia is the most prevalent disorder detected in samples sent to this laboratory. According to the American Heart Association's criterion for elevated cholesterol levels (260 mg/dl and above), our figures show that 41.6 percent of females and 34.2 percent of males tested in the United States are hypercholesterolemic. Cholesterol levels were observed to rise steadily after the age of 20 and to decline after age 60 in men and age 70 in women. Similar analysis for HDL cholesterol shows that 12.2 percent of men and 4.2 percent of women over 49 years of age have HDL cholesterol levels below 35 mg/dl, which, according to the guidelines from the Framingham Heart Study, would be classified as being at high risk for coronary heart disease. The mean HDL cholesterol level was about 10 mg/dl higher in women of all ages than in men of all ages. Diagnostic approaches to hyperlipidemia and clinical implications are discussed, and a guide for predicting the risk of coronary heart disease is provided.

Adolescent↗
PubMedDate not supplied

Hospital clinical laboratories are in a constant state of change.

In response to the accelerating changes in the health-care field, there has been a great deal of attention devoted to creating flexible designs and furnishings in hospital-based clinical laboratories. Even so, the hypothesis that hospital laboratories require a high degree of flexibility has been essentially untested. The aim of this study is to confirm or negate this need for flexible designs and furnishings as well as provide guidance for addressing flexibility in future hospital laboratory constructions and renovations. To explore the nature and rate of change in clinical laboratories, a multi-methodological approach employing both survey research and case study research was used to triangulate conclusions. Findings are organized into three areas: specific activities, technological processes, and the physical environment. The physical environment is further divided into three physical layers: infrastructure systems, space plan, and contents in the laboratory. This research supports the premise of planning and designing clinical laboratory environments that are flexible and versatile to support multiple laboratory applications. The goal of this study is to contribute to a body of knowledge that will help reduce the recurring problem of obsolescence in health-care buildings by understanding the relationship between activities, the technological processes, and the physical environment.

Automation↗
PubMedDate not supplied

Automated methods in urinalysis.

Automation has been an integral part of clinical laboratory testing for many years. In most moderate, or large laboratory settings, it is common to have a piece of equipment available to automate at least some, if not all portions of the urinalysis (UA). Examples range from the simple hand-held refractometer for the measurement of specific gravity, to a very sophisticated floor model instrument that performs the entire assay.

Automation↗
PubMed2004

Impact of the new Beckman Coulter Cytomics FC 500 5-color flow cytometer on a regional flow cytometry clinical laboratory service.

Calgary Laboratory Services (CLS) in Alberta, Canada, is the regional reference laboratory providing flow cytometry services for southern Alberta and southeastern British Columbia. As a busy reference flow laboratory we provide flow cytometry immunophenotyping for investigation and diagnosis of acute and chronic leukemias, lymphomas, immunodeficiencies, neuroblastoma, platelet disorders, and interstitial lung disease (ILD). Because of increasing workload and the continual effort to improve the service to our health care providers, CLS invested in the new Beckman Coulter Cytomics FC 500 5-color flow cytometer. In addition to time and labor savings due to reduced maintenance and operating system design, this new flow cytometer automates many of the previous manual steps involved in quality control and flow cytometric analysis. It also incorporates 2 lasers and is capable of measuring 5-color antibody combinations in a single tube, enabling us to reduce the number of tubes and overall costs, giving us better gating options for minimal residual disease analysis. We present the first published evaluation, an assessment of the overall productivity and cost impact of the new state-of-the-art Cytomics FC 500 flow cytometer. Implementation of the Cytomics FC 500 has resulted in a 20% reduction in reagent costs and shorter turnaround time for analysis and diagnosis. This instrument has allowed us to reduce our acute leukemia panel from 17 to 13 tubes, our lymphoma panel from 13 to 7 tubes, and our ILD panel from 4 to 2 tubes. The availability of 2 lasers provides more flexibility in choosing antibodies and conjugates to customize immunophenotyping panels. It also allows us to use the DRAQ5 dye and simultaneously analyze the immunophenotype and DNA content of cells with very little compensation. Many of the arduous, time-consuming flow operator tasks often associated with previous generation flow cytometry instruments, such as color compensation, list mode analysis, sample repeats, and interpretations, have been substantially reduced with the Cytomics FC 500 5-color flow cytometer. In conclusion the Cytomics FC 500 5-color flow cytometer is a major advance in flow cytometry instrumentation and has reduced our overall reagent costs by 20%, provided better information and speedier turnaround time to our health care professionals. It is an ideal flow cytometer for any busy clinical or research flow cytometry service.

Automation↗
PubMed1993

An automatic approach for DNA sequencing.

Automation is perfectly suited to DNA sequencing, which requires many repetitive steps and the handling of many samples. It increases not only processing capability but also accuracy and reproducibility. We present an approach to automation of DNA sequencing that was developed at the level of a research laboratory, and describe several improvements to DNA sequencing methodology.

Automation↗
PubMed2001

The essential role of information management in point-of-care/critical care testing.

Laboratory medicine is undergoing tremendous change in recent years driven primarily by technology, regulations, reimbursement, and market forces. In this paradigm shift, the laboratory is under tremendous pressure to adapt to new requirements for critical care testing. Indeed, laboratories have entered the information age where chemical data is being extracted from specimens in totally automated fashion. In the past, laboratory data has played a more historical role in the care of critically ill patients, arriving at the bedside too late to be of significant use in the active, ongoing care of the patient. However, today's physicians taking care of critically ill patients now require that laboratory results are made available in real-time and, if possible, at the patient's point-of-care. Many new testing point-of-care testing (POCT) devices have been developed to address this need however often laboratories implement such distributed devices with little or no attention to the information technology requirements. In fact, as little as 10% of point-of-care testing is actually managed by the central laboratory computer hence critically importance results are not found on the patient's electronic medical record. In addition, the billing and management data for point-of-care testing is often handled manually with no plans to interface point-of-care devices to the laboratory billing and management systems. Because of recent improvements of information handling and interface capability, such shortcomings in data management are no longer acceptable. Indeed, the demands for laboratories to utilize information technology are such that those laboratories with no overall plan for data management of critical care testing will probably not survive this market-driven paradigm. We present a discussion of the various approaches to computerization of point-of-care testing including the advantages and the disadvantages of each approach.

Critical Care↗
PubMed1992

In vitro and in vivo evaluation of cotton wool filtration of platelet concentrates obtained by automated and manual apheresis.

The effect of cotton wool filtration of apheresis platelet concentrates (PCs) on platelet viability and complement activation was evaluated by two laboratories. PCs were prepared by automated (Lab A, n = 5) or manual (Lab B, n = 5) apheresis. After storage for 1 day, the PC was filtered through cotton wool before transfusion on one occasion and, on the other occasion, filtered through a standard screen filter before transfusion to the same donor. Five paired studies were performed by each laboratory. Except for a small, but significant reduction in mean platelet size, from 7.3 +/- 1.1 to 6.6 +/- 0.9 microns 3, after cotton wool filtration, no effect of filtration on various tests of in vitro platelet function and morphologic integrity was found. As demonstrated by autologous radiolabeled studies, no effect of cotton wool filtration on platelet viability was found by Laboratory B, while Laboratory A found a slight increase in the percentage of recovery from 59 +/- 4 to 68 +/- 13 percent, and a small reduction in survival, from 8.2 +/- 0.9 to 7.7 +/- 0.5 days after cotton wool filtration (p less than 0.05). Cotton wool filtration was associated with a slight increase in C3a levels found in manual apheresis PCs. Neither laboratory found any effect of cotton wool filtration per se on the recipients' white cell (WBC) counts or C3a and C5a levels after transfusion.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed2006

Automated chemiluminescence-immunoassay for aldosterone during dynamic testing: comparison to radioimmunoassays with and without extraction steps.

BACKGROUND: Measurements of aldosterone have become more common since the recognition that primary aldosteronism is a more frequent cause of hypertension than previously believed. Our aim was to compare concentrations reported by 4 assays for samples obtained after saline infusion during dynamic testing. METHODS: We tested 104 participants (27 with primary aldosteronism, 30 with essential hypertension, and 47 healthy controls) with the intravenous saline infusion test (2.0 L isotonic saline over 4 h), with repetitive sampling. In all blood samples, aldosterone concentration was measured by an in-house RIA after extraction and chromatography, by 2 commercially available RIAs without extraction (Aldosterone Maia, Adaltis; Active Aldosterone, Diagnostics Systems Laboratories) and by an automated CLIA (Advantage, Nichols Institute Diagnostics). RESULTS: Correlation coefficients for results of pairs of assays ranged from 0.74 to 0.98. Agreement between commercial assays and in-house RIA was best at the low to intermediate concentrations after saline infusion. Mean (SD) Adaltis and DSL RIA results were 2- to 3-times higher [healthy participants: 78 (25) ng/L and 56 (18) ng/L, respectively] than those obtained by Nichols CLIA [17 (8) ng/L] and in-house RIA [23 (18) ng/L]. Aldosterone concentrations measured by the Nichols CLIA were below the limit of detection (limit of the blank) in 27 of 47 healthy participants. CONCLUSIONS: Aldosterone concentrations reported by the Adaltis and DSL nonextraction RIAs were consistently higher than those produced by the Nichols CLIA and the in-house RIA. The convenient Nichols CLIA showed better agreement with the in-house RIA, but the concentrations in healthy participants were frequently undetectable by this method. Uncritical application of cutoff values from the literature must be avoided.

Adult↗
PubMed1996

DNA-based carrier screening in primary healthcare: screening for aspartylglucosaminuria mutations in maternity health offices.

Large-scale genetic screening programs are complex enterprises in which ethical, technical, medical, and socioeconomic aspects have to be handled with professional expertise. Establishment of automated, relatively robust, and inexpensive laboratory techniques is one step of this path. Here a pilot carrier-screening program for the mutations causing aspartylglucosaminuria was carried out for pregnant women in primary care maternity health offices. Women (1975) were tested before their 12th week of pregnancy, and 31 heterozygotes were detected. The sampling was based on dried blood strips, facilitating convenient handling and inexpensive mailing to the laboratory. The mutation detection technique, solid-phase mini-sequencing simplified by the use of scintillation microplates and automated equipment, proved to be rapid, simple, inexpensive, and reliable, with a low repeat rate (2.5%). In conclusion, we found that good collaboration between the primary healthcare unit, the laboratory, and counseling experts, combined with modern laboratory technology, facilitate reliable low-cost genetic testing.

Acetylglucosamine↗
PubMed2000

Determining clinical laboratory science curriculum for the 21st century.

OBJECTIVE: To conduct a study to show possible differences in clinical laboratory science (CLS) education in relation to knowledge and skill levels deemed most important to job performance success of entry bench level CLS practitioners as determined by laboratory supervisors. Information gained from the study may indicate areas of program curriculum needing revision, or the incorporation of subject areas not presently offered. DESIGN: Survey. PARTICIPANTS: CLS educators from 100 different hospital-based and university-based CLS programs, and medical laboratory departmental supervisors from 209 different hospital laboratories. OUTCOME MEASURES: An analysis of the data from the survey consisted of individual item percentages generated by both surveys and a comparison of tasks deemed highly important by supervisors with class time estimates devoted to those tasks. RESULTS: The study indicated differences between what supervisors viewed as important knowledge and skills of entry bench level CLSs and the amount of class time devoted to those subjects by CLS educators. CONCLUSIONS: To ensure continuing professional credibility, additional study will be needed regarding the education and practice of CLSs as automation, emerging technologies, and laboratory restructuring will continue to change the laboratory environment.

Curriculum↗