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PubMedDate not supplied

Contributions to the development of laboratory equipment.

The author's most important original constructive achievements over a period of about 25 years are reviewed within the framework of the three modern trends in the field of laboratory equipment: miniaturization, automation, and computerization. Mention is made of more than 20 devices, pieces of apparatus and installations, designed in order to solve some problems raised by the physico-chemical investigation of biological systems, which can likewise be used for paraclinical diagnosis in biochemistry and virology laboratories.

Biochemistry↗
PubMed1977

The evolution of a functional real-time laboratory records retrieval and archival system.

The vast flood of information resulting from medical record keeping in a clinical laboratory must be cataloged and archived. To deal with this problem we designed an approach employing automated report generation by a laboratory computer, data base management of patient laboratory results, and automated microform generation via computer output microform (COM). This paper documents the steps that led to the system we are currently employing. The system described maintains the availability of current patient laboratory data, creates a microform archive and an on-line index, and serves as the data base for research inquiries. In addition, we have experienced a cost savings over manual procedures and now possess the capability of expansion without the costly addition of personnel.

Archives↗
PubMed1988

The Abbott IMx automated benchtop immunochemistry analyzer system.

We describe a new clinical laboratory instrument, the IMx, used to automate immunoassay testing in the clinical laboratory. The IMx incorporates a novel technology called Microparticle capture Enzyme ImmunoAssay (MEIA) for assays of high-molecular-mass analytes, and fluorescence polarization immunoassay (FPIA) for hapten assays. A front-surface fluorometer is used to quantify the enzymatic generation of fluorescent product at a rate proportional to the concentration of the analyte in an MEIA, and a fluorescence polarization optical system is used to quantify results in an FPIA. The microprocessor-based instrument uses a robotic arm with two degrees of freedom and a rotating carousel to process the samples for assay. One assay can be done on each of 24 patients' specimens in 30 to 40 min with "walk-away" automation. Calibration curves are stable for at least two weeks. Instrument control involves software-labeled "command keys," a numeric keypad, and an interactive display. Results are output to a thermal printer or computer interface.

Autoanalysis↗
PubMed2005

Optimal bedside urinalysis for the detection of proteinuria in hypertensive pregnancy: a study of diagnostic accuracy.

OBJECTIVE: To compare semi-quantitative visual and automated methods of urine testing with fully quantitative point of care urinalysis for the detection of significant proteinuria (0.3 g/24 hours) in pregnancy complicated by hypertension. DESIGN: A prospective comparative study. SETTING: A large teaching maternity hospital. SAMPLE: One hundred and seventy-one pregnant women referred to the obstetric day-care unit for assessment of newly arisen hypertension. METHODS: Early morning urine specimens were tested with four dipstick techniques (Multistix 8SG visual and automated and microalbumin/creatinine ratio visual and automated; Bayer, Elkhart, USA) as well as a fully quantitative measure of the microalbumin creatinine ratio with the DCA 2000 (a point of care assay for albumin; Bayer). These results were compared to a 24-hour urine protein measurement and measures of diagnostic accuracy/prediction are reported. MAIN OUTCOME MEASURES: Significant proteinuria (> or =0.3 g/24 hours) measured by laboratory assay. RESULTS: Automated dipstick urinalysis using the Clinitek 50 has significantly better predictive values for significant proteinuria (LR(+) 4.27, 95% CI 2.78 to 6.56; LR(-) 0.225, 95% CI 0.14 to 0.37) than conventional visual dipstick urinalysis (LR(+) 2.27, 95% CI 1.47 to 3.51; LR(-) 0.635, 95% CI 0.49 to 0.82). Dipstick microalbumin/creatinine ratio testing did not improve overall detection rates with automated or visual testing. Fully quantitative point of care measurement of albumin/creatinine ratio (ACR) was significantly better than any dipstick technique (LR(+) 14.6, 95% CI 6.74 to 31.8; LR(-) 0.069, 95% CI 0.030 to 0.16). CONCLUSIONS: This study confirms that in pregnancy automated dipstick urinalysis is a more accurate screening test for the detection of proteinuria than visual testing. ACR testing can offer a significant improvement over conventional urinalysis if a fully quantitative method of detection is employed that uses pregnancy-specific thresholds. Dipstick assessment of ACR does not improve the detection rate of significant proteinuria.

Adult↗
PubMed1998

Replacement of cinefilm with a digital archive and review network.

The replacement of cinefilm with digital cardiac angiography has accelerated significantly in recent years with the development and widespread adoption of the DICOM standard for interchange of procedure image data. While the acceptance of the Compact Disk-Recordable (CD-R) media has provided the opportunity for numerous laboratories to eliminate cinefilm in all its functions, the task is more complex for larger catheterization laboratories which require the use of high speed networks and automated libraries. The Cardiac Laboratory at the Mayo Clinic has implemented the final stages of a large-scale network and archive which meets a large institution's demanding requirements for access, speed, and storage for high volumes of digital cardiac angiographic images. Initial experience with the system demonstrates that this approach will be a successful one for the elimination of cinefilm and the employment of digital imaging and networking technology. In addition, direct access to digital image records will also facilitate the integration of image data with other clinical information acquired and stored in a digital format.

Cardiac Catheterization↗
PubMed2005

Laboratory screening of connective tissue diseases by a new automated ENA screening assay (EliA Symphony) in clinically defined patients.

BACKGROUND: The measurement of antinuclear antibodies (ANA) is used in the autoimmune laboratory for the screening of connective tissue diseases (CTD). ANA measurements are mainly performed by indirect immunofluorescence (IIF) on HEp-2 cells or by enzyme immunoassay (EIA). The objective of this study was to clinically evaluate an automated EIA for extractable nuclear antigens (ENA) which lacks anti-dsDNA for the screening of CTD. METHODS: The study involved a total of 170 serum samples, 54 from patients with CTD, 26 from patients with other autoimmune diseases, and 90 from patients with non-autoimmune diseases. For all sera, ANA detection was performed by IIF and by EliA Symphony (Pharmacia Diagnostics, Freiburg, Germany), an ENA screening which detects the following autoantibodies: SSA/Ro, SSB/La, U1RNP (70 kDa, A, C), Scl-70, JO-1, centromere B and Sm. Also, anti-dsDNA (EliA dsDNA, Pharmacia Diagnostics, Freiburg, Germany) was measured on all samples. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), efficiency, positive likelihood ratio (PLR), and negative likelihood ratio (NLR) were calculated. RESULTS: Diagnostic efficiency was similar for IIF (82.6%) and EliA Symphony (82.3%), as well as PLR (6.5 for IIF, and 7.3 for Eli Symphony), and NLR (0.35 for IIF, and 0.41 for EliA Symphony). The combined measurement of EliA Symphony and dsDNA increased sensitivity but not PLR. Area under receiver operator characteristic (ROC) curve was similar for IIF (0.847) and EliA Symphony (0.823). CONCLUSIONS: The results of the study demonstrate that EliA Symphony solely or combined with anti-dsDNA detection has an efficiency similar to HEp-2 cells IIF with a cut-off of 1:160 for the diagnosis of CTD.

Antibodies, Antinuclear↗
PubMed2001

Automated serological compatibility testing using a solid-phase test and standard laboratory equipment.

BACKGROUND AND OBJECTIVES: To prove the feasibility of a semi-automated cross-match procedure using a commercially available solid-phase microplate test and standard laboratory equipment. MATERIAL AND METHODS: The new procedure was evaluated against the conventional spin tube technique and the gel centrifugation system. RESULTS: The sensitivity of the method and the rate of non-specific reactions were equal to those for the other test systems. The samples taken from the red cell concentrates for cross-matching remained stable for the shelf-life of the product. CONCLUSION: The semi-automated cross-match was successfully introduced in our routine laboratory as a means to process large numbers of tests.

Blood Grouping and Crossmatching↗
PubMed1991

Intralaboratory performance and laboratorians' expectations for stat turnaround times. A College of American Pathologists Q-Probes study of four cerebrospinal fluid determinations.

More than 400 laboratories participated in the module of the College of American Pathologists' quality assurance program, Q-Probes, which measured intralaboratory turnaround time (TAT) of stat cerebrospinal fluid tests. Four determinations encompassing more than 14,000 specimens were monitored and intralaboratory TATs were compared with participants' TAT goals. The median TATs were as follows: cell count, 32 minutes; glucose, 34 minutes; protein, 37 minutes; and Gram's stain, 45 minutes. Between 14% and 21% of participants (test dependent) met their goals 100% of the time, with 72% of the determinations completed within the time laboratorians required. Standard statistical stepwise regression analysis was used to model influence of up to eight factors on TAT. Correlations were test and bed-size dependent, but ranged from a high of .23 to a low of .02. Only computerized reporting and instrumentation measuring protein and glucose had a consistent effect, delaying TAT, whereas use of a stat laboratory, one workstation, automation, computerized order entry, and centralized processing gave variable results. We conclude that laboratorian goals for cerebrospinal fluid test TAT are met most of the time, and that a stepwise regression analysis poorly explains factors that statistically influence TAT.

Cerebrospinal Fluid↗
PubMed1987

Evaluation and assessment of new disposable strip for determination of plasma potassium concentration.

Overall laboratory reproducibility for the Ames Seralyzer and plasma potassium test strips was less than 4% within the plasma reference range; and linearity extended from 2.1 to 10.2 mmol/l. Neither bilirubin nor lipaemia interfered in the analysis and selectivity for potassium over sodium was 450:1. Laboratory comparison with automated flame photometry and an indirect ion selective electrode showed a Seralyzer bias of +0.10 (+/- 25D 0.26) and +0.11 (0.27) mmol/l. Against flame photometry, comparison of analyses by six doctors from a coronary care unit and four nurses from a renal dialysis unit showed smaller positive biases (0.06 and 0.02 mmol/l) but substantially larger error ranges (0.43 and 0.55 mmol/l, respectively). Some 49% of the nurses' and 37% of the doctors' results differed from laboratory values by more than 0.2 mmol/l. Potassium test strip results proved acceptably comparable and reproducible when produced by an experienced analyst, but greater variability in clinical hands rendered the system unsuitable for precise monitoring of potassium concentration.

Humans↗
PubMed1999

Quality control, quality assessment of laboratory tests, lipid profile.

The first external quality control survey implemented by the Japan Medical Association was performed in 1967, and now. 2.400 or more laboratories are participating in this survey. The survey for total cholesterol was performed from the first survey, triglyceride survey was started in 1973, and survey of HDL-cholesterol was started in 1981. CVs of results for above items in the surveys were greatly improved after the 1980's. CVs in the 1970's were 8 to 10 per cent. but from the middle of the 1980's they were about 3 per cent or less. The main reason for this improvement is the introduction of automated analyzers in laboratories. An additional reason for this improvement is the requirement for accuracy of cholesterol determination by physicians, because the Japan Society of Atherosclerosis decided the consensus value of cholesterol for the initiation of treatment in 1987. Supply of standard material for cholesterol since 1995 is also a reason for this improvement. In 1995. CVs of cholesterol assays by were less than 3% when using most determination kits. Two determination kits, however, were found to give very high CVs. Both of them used dry chemistry, and the reason for these discrepancies was matrix effects of the survey material.

Automation↗
PubMed1996

Documenting data delivery: design, deployment, and decision.

Developing and deploying informatics solutions which are useful and acceptable to busy physicians are challenging tasks. We describe the design, deployment, and evaluation process by which the delivery of routine clinical laboratory reports is automated using electronic mail. Data from TMR, an operational computer-based patient record (CPR), are presented to providers using an individualized, modern interface. This system is compared to the existing, paper-based system for delivery of data from the same CPR. Differences between the two systems of data delivery are analyzed, with emphases on 1) electronic documentation of data delivery and receipt, 2) electronic and/or paper documentation of clinical action taken as a result of laboratory reports, 3) timeliness of report availability, 4) costs, 5) workflow compatibility, and 6) physician satisfaction. The new delivery system employs inexpensive, commercially available software applications and entails only trivial changes to the proprietary CPR. Built into the new system are features which allow quantitative measurements of its performance for analysis along with survey-based user satisfaction data. The open systems design is deliberately non-proprietary, inexpensive, and generalizable. Accordingly, it offers practical possibilities for settings in which clinical information systems are just being planned, as well as for those in which such systems are already established.

Clinical Laboratory Information Systems↗
PubMed1988

Automated sequence reading and analysis.

We report on a system developed by Bio-Rad Laboratories, Inc. which combines automated reading of DNA sequencing autoradiograms with comprehensive software for shotgun overlapping of the readings, analysis of the sequences derived and searching of databases. Reading is accomplished using a high speed optical scanner and pattern recognition software operating on a personal computer. Overlapping, analysis and database searching software each incorporate significant advances over prior systems.

Algorithms↗
PubMed1993

Comparison of an ELISA system for the quantification of hepatitis B antibody with an automated and a semi-automated system.

In order to manage the increased workload resulting from post vaccination hepatitis antibody testing of health care workers, the anti-hepatitis B ELISA assay ETI-AB-AUK (Sorin Biomedica), adapted for quantification using standards available as an addition to the qualitative kit assay (ABAU-STD-SET, (Sorin Biomedica)) and a sample pre-dilution step, was compared with a fully automated microparticle enzyme immunoassay IMX AUSAB (Abbott Laboratories), and a semi-automated enhanced luminescence system (Amerlite Amersham, now Kodak). Seventy-eight samples were concurrently tested and analysed statistically using a Regression Coefficient computer package (Apple Mackintosh Cricket). Good quantitative agreement was observed with ELISA vs IMX giving a linear correlation coefficient (r = 0.96). The linear correlation coefficient for ELISA vs Amerlite was r = 0.77. This study validates the use of the automated IMX system and allows the comparison of IMX results with previous 'semi-quantitative' ELISA results when longitudinally assessing patients response to a recombinant hepatitis B vaccine.

Autoanalysis↗