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Hematology laboratory standardization: a plan for harmonization in Asia.

Hematology laboratory is generally required in the hospital. At the macroscale, hematology laboratories have served a large number of population. In Asia, more than 3,000 million people are potentially to use the hematology laboratory service, particularly the complete blood count. Since 1970s, automated technology has been introduced to Asia and as years passed by, technology diversity is increasing. However, there are considerable number of hematology laboratories that have no automated machine. They are still relied on manual technology which is still variable in spectrophotometer for hemoglobin determination, centrifuge for hematocrit and diluting pipet for cell counting. In particular, blood smear preparation and interpretation are very difficult to control for standardization from person to person and laboratory to laboratory. Different methodology and a large population in the huge geographical area in Asia, the agreement of standard criteria is greatly important. This report has shown strategy and action plan to reach the goal of hematology laboratory standardization in Asia.

Asia↗

[Liposomal immunoassay as a method for detecting microorganism antigens and their antibodies].

The paper presents experimental data on the use of the liposomal immunoassay (LIA) with a fluorescence marker to detect lipopolysaccharide antigens (LPS-AG) of the causative agents of infectious diseases (S. typhimurium, S. typhi, F. tularensis) and antibodies to them in the model systems and human serum. The sensitivity of determination of specific antibodies to LPS-AG is shown to be 15-160 times as high as that of RPGA and the sensitivity of determination of LPS-AG is comparable to that of solid-phase enzyme immunoassay. The stability and storage of diagnostic immunoliposomal test systems are dealt with. It is shown that the liposomal diagnostic agents can be stable without losing their properties for years. Whether LIA is of diagnostic value in detecting salmonellosis in children in the clinical setting is discussed and the value of this assay is compared with that of other laboratory methods. The data on how LIA can be automated are presented. Its analytical advantages in using in laboratory diagnosis are discussed.

Antibodies, Bacterial↗

Comparison of the AcT 5 diff autoloader hematology analyzer to the Abbott Cell-Dyn 3200 analyzer at Charlevoix Area Hospital.

The Coulter AcT 5 diff autoloader (AL) hematology analyzer (Beckman Coulter, Fullerton, CA, USA) was evaluated at the Charlevoix Area Hospital, a small rural community hospital. The analyzer was compared to the laboratory's current instrument, a Cell-Dyn 3200 (Abbott Laboratories, Abbott Park, IL, USA). The study included comparisons of precision, efficiency and productivity, and reliability. The 5-part white blood cell differentials on both instruments were compared, and the clinical utility and flagging performance of both analyzers were confirmed by manual differential counts. The AcT 5 diff AL was shown to have excellent precision and accuracy. The addition of the autoloader to the AcT 5 diff provides a low-volume system with the added benefits of a "load and leave" analyzer normally available only to larger laboratories.

Automation↗

[Evaluation of the performance of the Coagulyzer II (Lancer)].

The automation of equipment is essential in laboratories performing a large number of procedures with high precision. An evaluation of performance characteristics of a photoelectric automated coagulation instrument, the Coagulyzer II (Lancer) is reported and compared with performances of the Coag-a-pet 200.

Autoanalysis↗

[The medical chemistry department].

The laboratory of clinical chemistry performs more than 300 different tests in biochemistry, hormone and tumor markers analysis, therapeutic drug monitoring and toxicology. For the most basic tests it has followed the trend of clinical chemistry towards automation and since 2001 the heart of the laboratory is a modular automated system (MODULAR) including a preanalytical platform, unique in Belgium. For more sophisticated tests, the most recent techniques have been implemented, in particular capillary electrophoresis and ICP-MS ("inductively coupled plasma-mass spectrometry). Since 1994, the laboratory has become a reference center in the field of erythrocyte hereditary diseases, combining screening, diagnosis and research. The other research themes are the physiopathology of first trimester pregnancy and the P2Y receptors of extracellular nucleotides.

Belgium↗

Reliability of the MS-2 system in detecting methicillin-resistant Staphylococcus aureus.

The MS-2 system (Abbott Diagnostics, Division of Abbott Laboratories, Dallas, Tex.) is an automated system capable of rapid antimicrobial susceptibility testing. However, the short incubation periods used by the device may adversely affect its ability to detect slowly growing resistant organisms. Shortly after the introduction of the MS-2 system into the University of Mississippi Medical Center clinical microbiology laboratory, we noted discrepancies between the MS-2 and the disk diffusion susceptibility reports when methicillin-resistant Staphylococcus aureus isolates were tested. Subsequently, we determined the susceptibilities of 75 such isolates by the MS-2 and Kirby-Bauer disk diffusion methods and measured the minimum inhibitory concentrations of methicillin, oxacillin, and cephalothin for 33 of the 75 isolates by standardized agar dilution techniques. There was only 47% overall agreement between the MS-2 and disk diffusion methods when methicillin was tested and 15% agreement when cephalothin was the test drug. There was 93% or more overall agreement between the two methods when other antimicrobial agents were tested. The minimum inhibitory concentration of methicillin was greater than or equal to 16 micrograms/ml for all 33 isolates evaluated by the agar dilution method. A comparison of the MS-2 and agar dilution results revealed an overall agreement of 49% when the susceptibilities to methicillin were determined. The MS-2 system reported that multiple methicillin-resistant S. aureus isolates obtained from a single patient were either resistant, intermediate, or sensitive to methicillin. Inconsistent results were also obtained when a single isolate was tested simultaneously in 10 cuvette cartridges. We conclude that the MS-2 system does not reliably detect methicillin and cephalothin resistance among S. aureus.

Cephalothin↗

[The use of programmed microcalculators for automation of leukocyte count].

Soviet programmed microcalculators are recommended to be used for the calculation of the leukocytic formulae when making serial blood analyses at clinical laboratories. The suggested program helps completely automate the process of estimating the leukocyte types, detectable in microscopic examination of the blood smears; the results may be obtained as a per cent ratio of the cells (a form most prevalent nowadays) and as their quantity per microliter of blood. The presence of service elements in the program essentially simplifies the work, making it convenient for an untrained user of the microcalculator. Since commercial Soviet programmed microcalculators somewhat differ in the systems of program steps, two variants of the program are suggested, adapted to the two most prevalent designs.

Computers↗

Knowledge-based automation.

Future technologic advances in microcomputer hardware will allow us to build complex interactive information systems that go far beyond conventional laboratory management functions to address the needs of laboratorians as well as physicians in patient care activities. These systems will use a "local-area network to transmit not only text but also images to workstations throughout a hospital. Unlike current systems driven from a central computer, future systems will decentralize much of the memory and processing to individual workstations." The expansion of software tools for modeling the decision-making process coupled with the development and testing of useful systems in relatively narrow problem domains will help the laboratory construct the necessary knowledge bases for future applications. Such systems will present complex medical data in a useful, informative manner, leading to a more rapid, consistent, and, it is hoped, cost effective decision making process. Utilizing these techniques, laboratory medicine can play a crucial role in fostering the appropriate and logical use of the laboratory.

Artificial Intelligence↗

Automation in blood banking. Machines for clumping, sticking, and gelling.

Hospital transfusion services and blood donor centers have continued to rely on manual hemagglutination methods for pretransfusion compatibility testing. Automation with continuous flow and batch analyzers has been practical only for the largest donor centers. During the last 20 years, other methods of streamlining compatibility testing have evolved. Two of the most successful approaches have used microplates to perform liquid agglutination tests or solid-phase, red cell adherence tests. More recently, a gel test has been developed. On the basis of these technologies, increasing numbers of semiautomated systems for compatibility testing have become commercially available. However, these systems primarily address the needs of large donor centers. New technologies are needed to automate the transfusion services of hospitals and other small laboratories.

Automation↗

Urinalysis and urinary tract infection: update for clinicians.

Dysuria is a common presenting complaint of women and urinalysis is a valuable tool in the initial evaluation of this presentation. Clinicians need to be aware that pyuria is the best determinate of bacteriuria requiring therapy and that values significant for infection differ depending on the method of analysis. A hemocytometer yields a value of > or = 10 WBC/mm3 significant for bacteriuria, while manual microscopy studies show > or = 8 WBC/high-power field reliably predicts a positive urine culture. In cases of uncomplicated symptomatic urinary tract infection, a positive value for nitrites and leukocyte esterase by urine dipstick can be treated without the need for a urine culture. Automated urinalysis used widely in large volume laboratories provides more sensitive detection of leukocytes and bacteria in the urine. With automated microscopy, a value of > 2 WBC/hpf is significant pyuria indicative of inflammation of the urinary tract. In complicated cases such as pregnancy, recurrent infection or renal involvement, further evaluation is necessary including manual microscopy and urine culture with sensitivities.

Female↗

LabLink--the key to multi-computer interfacing.

The growing complexity of computing environments requires creative solutions to prevent the gain in productivity promised by computing advances from being swallowed up by the necessity of moving information from one environment to another. LabLink is an interfacing tool for accomplishing such transfers in a clinical laboratory environment. It handles the automated data transfer among four systems, as well as providing substantial back-up capacity for critical operations when systems are down for saves or maintenance.

Blood Banks↗

Computer assisted laboratory diagnosis: a ten-year experience.

An automated procedure to help general practitioners in clinical diagnosis and decision making is presented. The computer-based program is conceived to process results from laboratory tests performed on outpatients, providing general practitioners with possible causes of abnormal results. When only one or two abnormal tests are observed, a series of suggestions pertinent to each abnormality is printed. When there are more abnormal test results, the program performs a more complex procedure ending with the output of some diagnostic hypotheses. Messages are also printed to focus the physician's attention to particular aspects of patient pathology that were sometimes missed or disregarded and to suggest new investigations the laboratory can perform to improve diagnostic efficiency. Moreover some advice is supplied to allow a better evaluation of particular risk conditions, as those associated with the development of coronary heart disease. The program has been recently extended with the calculation of intraindividual reference intervals. The system described has been working since 1976 and appears particularly useful when the general practitioner is faced with a number of pathological results of difficult interpretation.

Adolescent↗

The clinical chemistry laboratory: current status, problems and diagnostic prospects.

Although increased automation, advanced analytical techniques and sophisticated information technology have greatly improved the performance and quality in medical laboratory testing, several studies show that significant amounts of errors occur. Detailed analysis revealed that most of the errors occur in the preanalytical phase, while fewer errors occur in the intra- and post-analytical phase. The majority of errors are caused by wrong sampling or occur during transport to the laboratory. This review focuses on the analytical procedures in a large central laboratory. Possible problems are described by following samples from the patient to the laboratory and back. Finally, the advantages and disadvantages of point-of-care testing versus central laboratory are compared.

Calibration↗

New tools for laboratory design and management.

The clinical laboratory is changing from a place of activity based on sample analysis to an in vitro diagnostic network. To convince our team, partners, and administrators, we need new comprehensive tools to define a strategy with limited risk of failure or conflicts. Specific quality goals should be established before choosing automated tools for sample handling, analytical systems, laboratory information systems, communication systems, or advanced technologies. A system approach maps and simplifies the process, based more on a functional study than on classical disciplines. A customer-supplier approach establishes the requirements between partners either inside or outside the laboratory. The quality system must be a management tool, linking samples, tasks, information, and documents. Quantitative simulation modeling explores different automation alternatives and their impact on laboratory workflow. Finally, integration of results in interactive semirealistic simulation tools for laboratory design or reengineering can be used as communications tools to involve laboratory professionals in the change of their practice.

Chemistry, Clinical↗

The Vitek analyser for routine bacterial identification and susceptibility testing: protocols, problems, and pitfalls.

Automated and semiautomated technology in microbiology has seen great advances in recent years. The choice of automated equipment for the identification and susceptibility testing of bacteria in a routine diagnostic laboratory depends on speed, accuracy, ease of use, and cost factors. The Vitek analyser (bioMerieux, UK) was installed in a busy diagnostic teaching hospital laboratory in London. This report describes one year's experience. Changes to work practice as a result of incorporating the equipment into the laboratory, and the advantages and disadvantages of automation in key areas are described in detail, together with possible solutions to problems. The Vitek analyser was found to be valuable for the speed and accuracy with which results were available for the common bacterial pathogens. Results of susceptibility testing were standardised according to NCCLS guidelines and used breakpoint MICs to ascertain susceptibility and resistance; they were an improvement on disc testing. This equipment is not a reference facility for difficult to identify organisms and many manual techniques, including some disc susceptibility testing, will have to be retained by the laboratory.

Bacterial Typing Techniques↗

Organizational innovation and the laboratory information system.

There is an urgent need for more innovation in health care and in clinical laboratories. Innovation can be divided into five separate categories: core products, components of the core products, production processes, uses of products, and the organization of production. Organizational innovation is an important as technological advances in increasing the quality and efficiency of clinical laboratories. The use of a laboratory information system (LIS) can stimulate organizational innovation such as the assignment of computer-oriented tasks to personnel within individual clinical laboratories. The authors refer to such LIS support personnel as "hidden personnel" and suggest that such a shift of responsibility empowers laboratory professionals and makes them stakeholders in automated information processing.

Clinical Laboratory Information Systems↗

Elevated concentrations of C-reactive protein in subjects with type 2 diabetes mellitus are moderately influenced by glycemic control.

The aim of this study was to establish whether glycemic control results in decrease of C-reactive protein (CRP) in Type 2 diabetic subjects. Newly diagnosed Type 2 diabetic subjects were recruited and followed-up by 6-month intensive medical management. All the participants were carefully interviewed, clinically examined, and laboratory tested to exclude conditions likely to provoke an inflammatory response, which was an exclusion criterium. CRP was measured by automated microparticle enzyme immunoassay (IMx, Abbott Laboratories, USA). Two-hundred and forty-eight patients were included in the analysis of data. At baseline, average CRP levels were of 9.6 +/- 6.2 mg/l. Only 14 (5.7%) patients showed a fasting glucose equal or lower than 6.1 mmo/l (5.6 +/- 0.4 mmo/l); of them, 6 (42.8%) had elevated CRP levels (8.8 +/- 6.7 mg/l). The fasting glucose in the 234 (94.3%) non-controlled subjects was 13.1 +/- 4.8 mmol/l; of them 179 (76.5%) subjects showed elevated CRP levels (10.9 +/- 6.5 mg/I). At the end of the 6-month follow-up, the average fasting glucose and HbA1c in the overall group decreased from 12.5 +/- 5.0 to 9.0 +/- 1.6 mmol/l, p < 0.00001, and 13.0 +/- 4.9 to 8.9 +/- 2.9%, p < 0.00001, which resulted in a significant reduction of CRP levels (9.6 +/- 6.2 to 6.3 +/- 3.0 mg/l, p < 0.00001). Seventy-one (28.6%) patients reached glycemic control; however, only 29 (40.8%) of them reduced the CRP levels to 3 mg/l or less (1.3 +/- 1.9 mg/l), and the remaining 42 controlled patients maintained high CRP concentration (4.2 +/- 1.2 mg/I), p < 0.00001. Concentration of CRP is moderately influenced by glycemic control in the Type 2 diabetic subjects.

Adult↗