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An automated system for the handling, diluting, and dispensing of formaldehyde.

Automation can be applied to the repetitive and mechanical handling, mixing, and dispensing of formaldehyde, the most common tissue fixative in routine clinical laboratory use. A closed automated system is described that aspirates 37% formaldehyde from large, commercial sized 490 pound drums at a remote location, and delivers 10% formalin in ready-to-use form at a special faucet in the histology laboratory without human intervention. In addition to economy from a decrease in personnel handling time and from purchasing formaldehyde in bulk, it decreases the exposure of laboratory personnel to formaldehyde fumes.

Fixatives↗

Impact of new technology on employment prospects in clinical pathology.

Technological advances have changed the face of the clinical pathology laboratory. The introduction of automated instrumentation, computerisation and commercially prepared reagents has had a significant impact on the role, skills and employment prospect of laboratory scientists. The present study assessed the impact that technology has had amongst laboratory scientists employed in hospital biochemistry departments in N.S.W. The study showed that many traditional skills had been lost due to technological change. Very little growth is expected in the workforce over the next few years. New graduates should have difficulties in finding employment, especially in the routine areas of testing.

Clinical Competence↗

Evaluation of an indigenously manufactured rapid immunochromatographic test for detection of HBsAg.

A 'rapid' one step immunochromatographic, visually read, antigen capture assay--the "HEPACARD" (J Mitra & Co. Ltd., New Delhi, India) used for rapid screening of HBsAg was evaluated. Thousand consecutive sera sent to our laboratory for the purpose of HBsAg screening were tested by this device and by a third generation enzyme immunoassay (EIA) (Auszyme Monoclonal, Abbott Laboratories, Chicago, Illinois) or an automated Axsym microparticle enzyme immunoassay (MEIA) (Axsym HBsAg V2, Abbott Laboratories, Abbott Park, Chicago, Illinois, ISA). Hepacard showed a sensitivity of 79% (CU: 57.3-92%) and specificity of 98.9% (CI: 97.9-99.4%) when compared to the findings by the third generation EIA assays. This study suggested that this particular rapid HBsAg test results have to be confirmed by either an EIA or MEIA where the facility exists. The test may be used only in a small hospital setting where the facilities for enzyme immuno assays do not exist.

Antibodies, Monoclonal↗

Thromboplastin standardisation: calibrated lyophilised plasmas and coagulometer-specific international sensitivity indices.

The introduction of international reference preparations (IRP) of thromboplastins was an important step forward in the standardisation of laboratory monitoring of coumarin therapy for the treatment and prevention of thrombosis. In more recent years, the standard manual technique for prothrombin time (PT), which was used to monitor coumarin therapy, has been replaced gradually by a variety of different automated techniques in the laboratory. The international sensitivity index (ISI), assigned to a working thromboplastin by comparison to the IRP, is invalidated by the use of automated techniques, and is not necessarily consistent among analysers of the same type. Consequently, current recommendations are that individual laboratories should standardise their own thromboplastin with their routine method, using calibrated lyophilised plasmas which have international normalised ratios (INR) assigned to them.

Anticoagulants↗

Automated computer result reporting for haemoglobinopathy screening.

The anticipated introduction of universal antenatal screening can be expected to increase the workload of haemoglobinopathy laboratories throughout the country. We have devised a rule-based system to process those results that does not require skilled interpretation, thereby freeing staff time for more specialized work. The system relies on a calculated test to create a total haemoglobin peak value, which incorporates the values for HbA, HbA2 and HbF, the MCV and MCH from the full blood count. Each parameter has a series of defined ranges which, when subjected to an interpretation process within the laboratory computer system, generates an automated result text for the sample. During a 6-month verification period, the automated result interpretation system in conjunction with laboratory information systems (LIS) validation reduced the number of samples requiring manual review by 60%. The system was found to be 100% sensitive and 61.8% specific. We feel that the current specificity is acceptable in order to maintain a safe system. The ability to concentrate on potentially abnormal results will allow laboratories and health care workers more time to develop appropriate and timely frameworks to deal with abnormal results.

Clinical Laboratory Information Systems↗

On the selection of systems for automated cytogenetic analysis.

Impressive technological advances in systems for automated metaphase location and cytogenetic analysis have resulted in a proliferation of commercially available systems offering a variety of performance and price options. Based on the numbers of systems sold, it appears as if automation is becoming an accepted component of cytogenetic laboratories. To address the question of whether automation is useful and, if so, to identify the advantages and disadvantages of some of the systems, we have supplemented our own laboratory experience using the Magiscan routinely for clinical cytogenetic analysis, with information obtained during an on-site survey of other clinical cytogenetic facilities using automated systems (Genetiscan, Karyotype Image Editor, Metachrome, Cytoscan). Some systems provide both metaphase-locating and karyotyping capabilities--some only the latter. The basic structure of all systems is similar: microscope with camera, image processor, mechanism for operator interaction with the computer, hard copy printer. Metaphases are digitized, analyzed, and converted to permanent images. Metaphase-locating systems (Cytoscan, Magiscan, Metachrome) require, in addition, motorized slide-scanning stages. The biggest time savings resulting from use of automation is in the karyotyping steps, especially the production of a hard copy. Consequently, laboratories making many karyotypes will benefit most from such systems. The optimum choice of system will depend on specific laboratory parameters: number and type of specimens processed; operational preferences, e.g., number of bands per metaphase; number of metaphases counted; and karyotypes prepared per case. Laboratories processing chorionic villus specimens and/or bone marrows, where much slide area must be searched, will benefit from fast metaphase locators with multislide stages.(ABSTRACT TRUNCATED AT 250 WORDS)

Computers↗

Rapid screening test for primary hyperaldosteronism: ratio of plasma aldosterone to renin concentration determined by fully automated chemiluminescence immunoassays.

BACKGROUND: The ratio of plasma aldosterone concentration to plasma renin activity (PAC/PRA) is the most common screening test for primary hyperaldosteronism (PHA), but it is not standardized among laboratories. We evaluated new automated assays for the simultaneous measurement of PAC and plasma renin concentration (PRC). METHODS: We studied 76 healthy normotensive volunteers and 28 patients with confirmed PHA. PAC and PRC were measured immunochemically in EDTA plasma on the Nichols Advantage chemiluminescence analyzer, and PRA was determined by an activity assay. RESULTS: In volunteers, PAC varied from 33.3 to 1930 pmol/L, PRA from 1.13 to 19.7 ng.mL(-1).h(-1) (0.215 ng.mL(-1).h(-1) = 1 pmol.L(-1).s(-1)), and PRC from 5.70 to 116 mU/L. PAC/PRA ratios ranged from 4.35 to 494 (pmol/L)/(ng.mL(-1).h(-1)) and PAC/PRC ratios from 0.69 to 71.0 pmol/mU. In PHA patients, PAC ranged from 158 to 5012 pmol/L, PRA from 0.40 to 1.70 ng.mL(-1).h(-1), and PRC from 0.80 to 11.7 mU/L. PAC/PRA ratios were between 298 and 6756 (pmol/L)/(ng.mL(-1).h(-1)) and PAC/PRC ratios between 105 and 2328 pmol/mU. Whereas PAC or PRC showed broad overlap between PHA patients and volunteers, the PAC/PRC ratio indicated distinct discrimination of these two groups at a cutoff of 71 pmol/mU. CONCLUSION: The PAC/PRC ratio offers several practical advantages compared with the PAC/PRA screening method. The present study offers preliminary evidence that it may be a useful screening test for PHA. Further studies are required to validate these results, especially in hypertensive cohorts.

Adolescent↗

Multilevel lab networks: PC-mini blend with a twist.

Today's clinical laboratory is a partially automated, transaction-intensive environment. The advent of what Dr. Perry Seamonds calls "multilevel" networks puts sophisticated, efficient processing within reach of laboratories that may have been relying on less powerful networking systems.

Clinical Laboratory Information Systems↗

Accuracy of urine dipstick to predict urinary tract infections in an emergency department.

BACKGROUND: Urine dipstick is a useful and commonly used test in the Emergency Department because of its rapidity and low cost; however its diagnostic accuracy is debatable. Our objective was to compare the urine dipstick and urinalysis for Urinary Tract Infection in a developing country, where there are significant cost considerations. METHODS: This was an observational study of adults' patients presenting to Section of Emergency section (SEM) of the Aga Khan University Hospital, from March to May 1998. The patient's urine sample was tested immediately, using the Multistix 10SG. The sample was sent within one hour to the hospital laboratory for analysis, while the urinary specimen was sent for culture, where appropriate. The dipstick results were compared with the results of automated urinalysis in the laboratory, leukocyte counts on microscopy and urine culture. Sensitivity, Specificity, and predictive values were also calculated. RESULTS: We evaluated 984 samples of urine during the study period. The sensitivity of nitrite test was 81% and that of leukocyte esterase 77% for positive cultures. However, the sensitivity for combined nitrite and leukocyte esterase test was 94%. Nitrite test was more specific (87%) than leukocyte esterase test (54%) or both tests taken together (50%). The predictive value of nitrite and leukocyte esterase together for a negative urine culture was 95%. Leukocyte esterase test sensitivity increased as the number of white blood cells on microscopy increased. Similarly the predictive value of leukocytes on microscopy for a positive culture increased as the number of leukocytes increased. CONCLUSION: Dipstick alone cannot accurately predict urinary tract infection in emergency department.

Carboxylic Ester Hydrolases↗

Description and first clinical use of a new system for combined mammography and automated clinical amplitude/velocity reconstructive imaging breast sonography.

RATIONALE AND OBJECTIVES: The authors tested a new automated system for clinical amplitude/velocity reconstructive imaging (CARI) breast sonography and compared the results with those of a manual laboratory model of this imaging modality, conventional sonography, and mammography. METHODS: Fifty-one patients with breast lesions were examined by mammography, conventional breast sonography, a laboratory version of a mammography-like breast compression device for breast sonography, and an automated system that allows sonography while in compression and reconstructs an image of the whole breast. The automated device allows reconstruction of one image per breast from an automatically acquired sonographic data set and simultaneous performance of mammography. The results of mammography and all modes of sonography were compared with histopathology in 36 surgically treated lesions of which 20 were benign and 16 malignant. In addition, 17 lesions confirmed to be benign by different imaging modalities were examined with the three different sonographic devices. RESULTS: All 16 histopathologically proven malignant lesions were identified correctly by compression sonography (laboratory and automated device) compared with 14 by conventional sonography. Of the 20 benign lesions, 16 were interpreted correctly by conventional sonography, 19 with the laboratory version, and 18 with the automated device, whereas mammography identified 12 benign lesions correctly and missed 1 malignant lesion. Only 16 of 17 lesions diagnosed to be benign by outpatient imaging could be examined with all three modes of study sonography and were found to be benign with all three modes in all cases. CONCLUSIONS: Compared with the laboratory version, the automated device facilitates acquisition and evaluation of compression breast sonography and is similar in lesion detection and differentiation. It should be tested in a larger number of patients.

Adult↗

Comparison of the E-test method with an automated bacterial identification and antimicrobial susceptibility detection system for screening extended-spectrum beta-lactamase producers.

Some automated systems used in clinical microbiology laboratories are able to detect products responsible for antimicrobial resistance. In this study, 626 isolates (436 Escherichia coli, 134 Klebsiella pneumoniae and 56 Klebsiella oxytoca strains) were examined for the presumptive detection of extended-spectrum beta-lactamase (ESBL) production by 2 methods: the Sceptor system (BD, Sparks, MD, USA) and the E-test. ESBL production was detected in 26 E. coli strains (5.96%), 60 K. pneumoniae strains (44.77%) and 15 K. oxytoca strains (26.78%) by ceftazidime/ceftazidime-clavulanate E-test. Using the E-test, ESBL production was detected in 25 of 201 E. coli strains (12.43%), 55 of 75 K. pneumoniae (73.33%) and 14 of 27 K. oxytoca strains (51.85%) that were alerted as ESBL-producing strains by the Sceptor system. ESBL positivity was detected in 1 E. coli, 5 K. pneumoniae and 1 K. oxytoca strains, that were not warned as being ESBL producers by the Sceptor system. These data suggest that clinical microbiology laboratories should not only rely on these rapid automated systems but also use another method for screening ESBL producers, such as the E-test. The rates of these ESBL-producing isolates in this study were lower than those in other studies reported from other parts of Turkey, but higher than those reported from the USA and Europe.

Automation↗

Automation in blood banking.

During the past decade, automation took a major place in blood transfusion laboratories. Now many centers have purchased automated equipment and subsequently undertaken the computerization of their activities. The aim of this paper is to review the state of the art in the field of automation and to try to estimate future tendencies.

Automation↗

[Highly advanced microbiological test system for the 21st century].

One of the most serious problems in microbiological tests performed in clinical laboratories is that more than 3 days are required for doctors to obtain a full report, so effective treatment cannot be performed quickly. Furthermore, Japanese medical students are generally not well-educated on clinical microbiology so that only a few doctors can interpret the test results correctly and determine proper treatment. Therefore, a highly advanced laboratory system is needed in clinical microbiology. We developed a highly automated and well-organized laboratory system, by which bacterial identification tests and susceptibility tests can be completed within 6 and 4 hours, respectively. In addition, full-colored pictures (e.g., Gram stained specimens) are attached to the reports to improve the doctor's comprehension. Furthermore, we devised a quick medical reference system to support antimicrobial chemotherapy. This is a unique system in Japan that will help doctors to provide effective therapy.

Forecasting↗

Spuriously elevated automated platelet count in severe burns--a report of two cases.

Increasing use of automated analyzers in the hematology laboratory has resulted in enhanced accuracy of results. However, operators of automated analyzers and the end users utilizing the automated data need to be aware of factitious results which might be reported at times by these instruments. Case summaries of two patients with severe burns showing spuriously elevated automated platelet count are presented here.

Adolescent↗

A multicenter study on amidolytic factor X evaluation in oral anticoagulant therapy.

For laboratory control of oral anticoagulation, amidolytic factor X (F X) determination may offer an alternative to standardization difficulties of prothrombin time (PT). In order to validate this amidolytic assay on a large scale, a multicenter study was undertaken in 6 French laboratories using the same chromogenic substrate (Stachrom X Stago) and different automated instruments. Intra and between laboratory reproducibility of factor X was estimated on fresh and lyophilized patients plasmas and was found to be highly satisfactory. Standardization of the method did not seem to depend on the chromogenic substrate used, as investigated in two different centers. Results of PT and factor X were compared in over 500 patients on a long-term stabilized oral anticoagulant treatment: there was a strong positive correlation between the 2 tests in each center. The therapeutic range for factor X was evaluated from therapeutic PT values reported by Duckert and Marbet for the different thromboplastin reagents: the estimated mean range was 21 to 32%. Pooling the results of the six different centers a concordant information for prothrombin time and factor X amidolytic assay was found in 76% of patients and a fully discordant response was present in 0.6%. The results suggest that amidolytic factor X may be suitable for monitoring long-term anticoagulation. However, prospective trials are needed to evaluate its usefulness as compared to conventional methods.

Administration, Oral↗

Robotics in the clinical laboratory.

We are beginning to see the potential of robotics in the clinical laboratory through integration with automated analyzers and computer systems. However, there is a need for training programs that will prepare technologists to design and implement robotic systems for clinical laboratories. What will the robot laboratory of the future look like? We will see hospital laboratories begin to be located some distance away from the main facility because the labor component of staffing satellite laboratories will have been greatly reduced. Instrument manufacturers will see the need for analyzers that are robot-friendly and allow for simplified interfacing, both electronic and mechanical. Robots will become more versatile even to the point of performing complete instrument repair. Laboratories will be equipped with many task-oriented robotic stations, including, for example, accessioning and processing robots that prepare samples for transport by robotic carts. Analysis will be performed by a combination of robot and dedicated analyzer. Laboratory results will be reviewed by algorithms in the larger laboratory computer, which will alert the laboratory worker to unusual results. A large variety of analyses will be available to the patient with rapid turnaround. The end result will be more efficient health care delivery at reduced cost.

Computer Communication Networks↗