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Cell processing: current status and future directions.

Specialized clinical cell processing began in the Department of Transfusion Medicine at the National Institutes of Health in 1984. The number and complexity of procedures performed increased quickly and in 1997 a highly specialized cell processing laboratory was opened. The laboratory has approximately 3,000 square feet, specialized air handing, a highly trained staff, and written laboratory procedures. In addition to standard laboratory equipment, the laboratory has numerous cell isolation instruments, flow cytometers, and automated cell counting instruments. The laboratory supports blood and bone marrow transplant protocols by isolating CD34+ stem cells, removing T lymphocytes, culturing lymphocytes to eliminate donor lymphocytes that are reactive with recipient alloantigens, and stimulating lymphocytes to induce Th2 type cells to reduce graft versus host disease. The laboratory has also been preparing dendritic cells to support protocols using immune therapy to treat cancer. In addition, pancreatic islet cells are isolated from organ donors for transplantation to treat type I diabetes mellitus.

Antigens, CD34↗

[The assessment of quick turnaround service in clinical laboratories].

The quick turnaround service of laboratory data has been a basic and fundamental service of clinical laboratories. To realize this service, there are three basic requirements in the hospital and laboratory information systems. The first is cooperation with the hospital information system providing bar-coded label sampling system and test requisition from the information system terminal. The second is real time quality assurance system fully supported from the laboratory information system. The third is random and sequential automated analyzer supported by the bar-code system. In 1994, we set up an automated system in our clinical laboratories. The effect of the quick turnaround service of reporting was analyzed and is discussed herein. Employing this system, the quick turnaround service system was established for 31 items of biochemistry, glucose, Thrombo test and complete cell counting of hematology. Furthermore, these items were available within 30 minutes before medical consultation. Effective sample conveying system, quick sample preparation without clotting and arrival information system of laboratory data as a mailing system are further requirements for this quick turnaround service system.

Clinical Laboratory Information Systems↗

Evaluation of the automated phoenix system for potential routine use in the clinical microbiology laboratory.

A comparative study was designed to evaluate the identification (ID) and antimicrobial susceptibility testing (AST) performances of the BD Phoenix Automated Microbiology System (Becton Dickinson Diagnostic Systems [BD], Pont de Claix, France). A total of 305 single clinical isolates were collected, and comparisons were made with routine manual methods in use in our microbiology laboratories. The percentages of correct IDs were 93.3, 89.4, 91.8, and 85.7% for enterobacteria, nonfermenting gram-negative bacilli, staphylococci, and streptococci-enterococci, respectively. The median ID time was 3 h, and the median time for AST was 10 h 30 min. AST results showed variable percentages of errors for the different antibiotics. None of the enterobacteria and 0.3% of Pseudomonas aeruginosa isolates showed a very major error (VME). Only one strain of Staphylococcus aureus showed a VME with oxacillin. We demonstrate here the efficiency of the Phoenix system, which can be used for the majority of strains encountered in a university-based laboratory, for ID and AST.

Anti-Bacterial Agents↗

Quality control validation in veterinary laboratories.

Quality control (QC) validation is used to determine: 1) whether statistical QC procedures are appropriate for detecting medically important errors; and 2) the equality of performance required by different laboratory tests. QC validation is well documented in the medical literature, but we are unaware of studies addressing its application, problems or unique differences in veterinary laboratories. We applied QC validation to automated hematology and biochemistry analyses in our laboratories, with goals of >/= 90% probability of error detection and </= 5% probability of false rejection. Analytical quality requirements in the form of total allowable error were defined using regulatory criteria for human proficiency testing; these were later modified based on clinician and pathologist feedback. Initial QC goals were not met for 14 of 49 (28.6%) analyte-control combinations. Subsequent modifications in methodology, analytical quality requirements and technician training achieved QC goals for all but one analyte. For this analyte (platelet count, low control), nonstatistical QC procedures were emphasized. QC validation was beneficial for clarifying statistical QC performance, and for assessing the need and justification for changes in methods and personnel training. The validation exercise allowed simplification of QC rules, enabled machine flagging of abnormal results, and decreased time and expense associated with QC recording, analysis, problem-solving and reruns. QC validation is recommended for all veterinary laboratories as a useful tool in total quality management.

Journal Article↗

Computers in clinical laboratory management in Singapore.

In 1974, an off-line mini-computer system was introduced in the Clinical Biochemistry Laboratories of the Government Department of Pathology in Singapore. With the resiting of the 24-hour emergency biochemistry laboratory on the same floor as the Haematology Department within the new Singapore General Hospital, an on-line computer system was installed in 1983 to serve both the emergency biochemistry and haematology laboratories. An almost identical on-line system was also purchased in 1984 to replace the aged off-line system at the Department of Pathology. A description of the new computer systems based on Eclipse S/140 computers and Medical Information Technology (Meditech) software using Meditech Interpretive Information System (MIIS) language will be given. The specific features required and the selection criteria for the on-line systems are also discussed. The systems are used for the acquisition and processing of all patient and test data of the laboratories, direct capture of data from automated instruments, generation of work schedules and laboratory reports, compilation of work done, workload and revenue statistics and a variety of other reports. Patient cumulative records and quality control statistics are available on a real-time basis, thus greatly facilitating enquiries on patient results and monitoring of analytical performance. Prior experience with an off-line system and careful planning have been helpful in greatly shortening the preparatory period required for the smooth implementation of the on-line systems. Use of the systems has significantly improved laboratory management and has resulted in improved quality, and higher efficiency and productivity.

Chemistry, Clinical↗

Changes in the American health care system: crisis in the clinical laboratory.

American medicine is undergoing unprecedented changes, and the resulting distortions are affecting the economics, organization and operations of all clinical laboratories. Professionals who work in these laboratories are facing administrative and economic pressures to reduce costs, to increase productivity, and to comply with proliferating new statutes and regulations. The medical 'cottage industry' in which the patient was the focus of the medical professionals' attention and endeavours is being replaced by the corporate management of many health care activities in which financial profits are being given first priority. Medical facilities, including clinical laboratories, are being bought and sold, being consolidated, or simply being closed. The clinical laboratories may be at the vortex of the maelstrom affecting American medicine. Cost pressures are encouraging further automation and retraining of laboratory staffs. If the leaders in laboratory medicine are unable to accomplish the necessary tasks to meet the new challenges, there inevitably is a non-medical, non-scientific financial manager at hand who is willing to define the changes and the desired outcome. Because of the rapidity of the changes taking place, it is not possible to predict with any confidence the modifications that will achieve a permanent status or the degree to which medical professionals will remain masters of their fates. The evolving health care system will become less costly, more technologically advanced, and a more challenging system in which to work.

Autoanalysis↗

Quantitative measurement of serum and plasma lysozyme: an automated method.

The demand for laboratory testing of blood lysozyme levels is increasing markedly. Although of limited value in the initial diagnosis of leukaemia, the importance of lysozyme levels in leukaemia management is rapidly being realised. An established manual method was examined in a successful attempt to develop an improved automated method using a centrifugal analyser. In comparison of serum and plasma the results showed no significant difference, indicating that the method described could use either material. The automated method was quicker, easier, more economical and more precise than the manual method it replaced.

Autoanalysis↗

Evaluation of a new automated, rapid, colorimetric culture system using solid medium for laboratory diagnosis of tuberculosis and determination of anti-tuberculosis drug susceptibility.

SETTING: Department of Microbiology and Clinical Microbiology, Gulhane Military Medical Academy, Ankara, Turkey, a tertiary referral hospital in a region endemic for tuberculosis. OBJECTIVE: To evaluate the performance of the Dio-TK Culture System (CS), a new, rapid, automated colorimetric culture system. DESIGN: Dio-TK CS results were compared with routinely used Löwenstein Jensen (LJ) medium and Bactec 460 TB. RESULTS: In this study, 449 specimens, mostly sputum samples obtained from 348 patients, were evaluated. Mycobacteria were isolated from 31 (6.9%), 23 (5.1%), 18 (4.0%) and 21 (4.7%) of the specimens using Bactec 12B, LJ, Dio-TK Medium and Dio-TK SLC (selective), respectively. The mean time to detection of growth of 13 isolates by Bactec 12B, Dio-TK Medium, Dio-TK SLC and LJ medium was respectively 8.9, 15.1, 17.0 and 26.1 days. CONCLUSION: Dio-TK may be a practical and rapid culture system for daily use. However, the manufacturer should improve the system to minimise the effects of manipulation errors. Comparative studies with a larger number of isolates are needed to standardise drug concentrations used in anti-tuberculosis drug susceptibility testing.

Antitubercular Agents↗

Evaluation of a prototype Trypanosoma cruzi antibody assay with recombinant antigens on a fully automated chemiluminescence analyzer for blood donor screening.

BACKGROUND: Chagas disease is caused by Trypanosoma cruzi, a protozoan parasite that can be transmitted by transfusion. The diagnosis of chronic T. cruzi infection is generally made by detecting specific antibodies that bind to parasite antigens. The aim of this study was to assess the sensitivity and specificity of a new serologic assay for antibodies to T. cruzi on a fully automated analyzer (PRISM, Abbott Laboratories). STUDY DESIGN AND METHODS: A prototype chemiluminescent immunoassay based on chimeric recombinant antigens and run on the automated PRISM system was developed for detecting antibodies to T. cruzi in human serum and plasma. Assay specificity was evaluated by testing samples from random blood donors and from a diverse group of specimens from persons with diseases or conditions often associated with false-positive reactions in T. cruzi assays. Sensitivity was determined by testing 377 geographically diverse T. cruzi antibody-positive specimens. RESULTS: Six of 7911 samples (0.08%) from random donors were repeatedly reactive in the prototype PRISM Chagas assay. One of these was reactive in three other tests, including the radioimmune precipitation assay and was presumed to be a true positive. Hence, the specificity was 99.94 percent (7905/7910) in the negative donor group studied. All 377 T. cruzi antibody-positive specimens were positive in the prototype assay and thus the sensitivity was 100 percent. CONCLUSION: The results obtained to date, in terms of sensitivity as well as specificity, strongly suggest that the PRISM Chagas assay should function well as a tool for screening blood for serologic evidence of T. cruzi infection.

Animals↗

Laboratory reengineering facilitates cost management.

In 1993, The Medical University of South Carolina (MUSC) in Charleston undertook a change management initiative to achieve a more cost-competitive position in its market and become a more attractive partner for a possible future affiliation with another provider organization. A key element of this change process was a reorganization of the medical center's laboratory department. Through consolidation of MUSC's separate laboratories and the introduction of a new, more efficient chemistry analyzer system, the medical center realized annual laboratory savings of approximately $1.3 million.

Automation↗

Magnetically tagged subsets of human lymphocytes for assays with laboratory robotics.

We demonstrate the possibility of automation of whole-cell functionality assays, e.g., mitogen-activated DNA synthesis, DNA repair synthesis, and assessment of drug-metabolizing enzymes, by use of magnetic separation technology. We have attached antibody-coupled magnetic microspheres to the surface of human T-lymphocytes before performing various assays. Evaluating the biological functions of T-cells estimated by the DNA-synthesis assays showed that the presence of antibody-coupled magnetic microspheres did not affect the results (P greater than 0.05). The concentration of adenosine diphosphate ribosyltransferase (EC 2.4.2.30) was shown to be influenced by the magnetic microspheres. However, the amount of enzyme activity induced by oxidative stress was not significantly altered. The results from assays of the phase II drug-metabolizing enzymes glutathione transferase (EC 2.5.1.18) and epoxide hydrolase (EC 3.3.2.3) as well as evaluation of the proliferative response of polyclonal activators (phytohemagglutinin, staphylococcal enterotoxin A, and pokeweed mitogen) support our conclusion that assays can be performed on viable magnetized cells. The use of magnetized cells holds promise for further applications in automated genotoxic and immunological cell assays of mononuclear leukocyte subsets. Laboratory robotics will be essential in bringing these assays into routine use.

Antibodies, Monoclonal↗

Problems in laboratories of developing countries: the Korean experience.

The problems of managing clinical biochemical laboratories are varied. They range from deficiencies in communication and fragmentation of services to misconceptions of the use of automation. The common symptoms of inadequate management are outlined and solutions proposed against the background of the Korean experience.

Automation↗

Activated partial thromboplastin time for automated techniques: a comparison of two commonly used reagents.

In a comparison between two widely used activated partial thromboplastin time reagents (Instrumentation Laboratories, Manchester low-opacity), using one popular instrument (Automated Coagulation Laboratory, model 300R), a wide range of defects and 40 normals were tested. There was generally good agreement between methods, although for samples from patients on high heparin dosages the agreement was poor. The manufacturer's recommendation for the therapeutic range for heparin for the Instrumentation Laboratory reagent was lower than the range in current general use. The Manchester reagent was more sensitive to the lupus anticoagulant.

Heparin↗