[The development of the work of the medical technician assistant in increasing automatization].
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Twelve Lipid Research Clinic laboratories performed automated fluorometric triglyceride analyses on four control serum pools of known concentration by a modified Hantzsch reaction. The analyses were done during a two-year period, with use of common standards, methodology, and quality-control procedures. Estimates of analytical bias, variability, and short- and long-term trends for each instrument and for the entire group of LRC instruments are presented. High accuracy, precision, and interlaboratory comparability were achieved through rigorous standardization and control of the entire analytical procedure. Individual instrument biases varied from an average of 4.9% below to 1.0% above reference values. Between-run variability was often less than within-run variability and interlaboratory variation was substantially less than intralaboratory variation. The total standard deviation for all instruments ranged from 37 to 63 mg/liter. Only 5 to 14% of this variation was due to differences among instruments. The among-instruments standard deviation ranged from 12 to 17 mg/liter; the between-run, within-instrument standard deviation ranged from 29 to 46 mg/liter, and within-run standard deviation from 27 to 40 mg/liter. The significance of the results for long-term collaborative studies is discussed.
The long-term prereconstitution stability of sodium and potassium in large pools of lyophilized quality control serum used in Regional Quality Control Programs, conducted between 1977 and 1980 is reviewed. In approximately one third of 27 pools studied, minimal but significant increases in sodium concentration were detected, these increases averaged less than 0.50 per year and confirmed our previously reported results from pools analyzed between 1973 and 1976. Results relating to potassium stability have been inconsistent. The previously reported tendency for potassium to increase in some pools was again suggested by data obtained from laboratories using automated flame-emission photometry procedures. This was not confirmed, however, by the data reflecting manual/semi-automated flame-emission photometry procedures or automated electrode methods. It is postulated, that the source of sodium causing the increases in concentration is the glass containers in which control materials are stored between the time of manufacture and reconstitution. Regression analysis against time of monthly interlaboratory means, from participants in Regional Quality Control Programs, is a useful tool for evaluating postmanufacture stability of analytes in pools used for daily internal quality control procedures.
Follicular lymphomas comprise almost two thirds of the US adult non-Hodgkin's lymphomas (NHL) and are the most common malignancy of B-lineage lymphocytes. Polymerase chain reaction (PCR) protocols have been developed to detect the t(14;18) translocation, which juxtaposes the bcl-2 proto-oncogene to the Ig heavy-chain (IgH) gene in 85% of follicular lymphomas and monoclonal rearrangements of the IgH gene in B-cell NHL that lack bcl-2 rearrangements. We used PCR to amplify bcl-2 and IgH rearrangements in DNA from patients with lymphoproliferative disorders and analyzed the products in parallel by gel electrophoresis and flow cytometry, which detected PCR products incorporating fluoresceinated oligonucleotide primers by sequence-specific capture to oligonucleotide-coated magnetic beads. Overall, flow cytometry was superior to electrophoresis of ethidium-bromide-stained agarose gels for detection of products of nested PCR to detect intergenic rearrangements involving bcl-2 and single primer-pair amplification of clonal rearrangement of IgH. Flow cytometric analysis detected bcl-2 translocations in 12 of 13 CD10+ B-cell lymphomas and clonal IgH rearrangements in 14 of 17 monoclonal B-cell populations. In contrast, analysis by gel electrophoresis detected bcl-2 translocations in only 10 of 13 CD10+ and clonal IgH gene rearrangements in only 9 of 17 monoclonal B-cell populations. Flow cytometric analysis was more sensitive than gel electrophoresis and could detect a 16-fold greater dilution of a bcl-2-amplified product than gel electrophoresis. Similarly, flow cytometry could detect an amplification product when template DNA was diluted 10,000-fold, whereas gel electrophoresis only detected amplification products when template was subjected to dilution between 100- and 1,000-fold. This shows the utility of flow cytometry for the analysis of DNA amplification products incorporating fluorochrome-labeled primers as a rapid, objective alternative to conventional strategies. Because current-generation clinical laboratories emphasize automation, flow cytometric analysis of PCR-amplified products shows increased analytic sensitivity and offers a vehicle for automation of DNA amplification tests.
Computer-aided sperm analysis (CASA) technology is 7 years old. Over 120 papers have been written that verify the technology or apply it in basic and clinical studies. Most of the technical problems with CASA, such as the dependence of velocity on video frame rate, inaccuracy of count and percent motility for low- and high-concentration specimens, parameter dependence on the number of frames analyzed, sensitivity of the subjective threshold setting, confusion over the presence of debris, and different implementations of algorithms across instruments, still persist. A critical review of the literature reveals that no standard practices are followed within or across instruments. Moreover, no standards have been embraced or recommended by professional societies. Despite its potential to provide objective measurements of specimen and individual sperm parameters, and to automate the laboratory semen analysis, the promise of CASA has not been fulfilled. Unless laboratory medicine defines instrument performance and laboratory standards and co-operates with industry to achieve these goals, CASA technology may remain a research curiosity. This outcome is especially worrisome in the context of increasing requirements for laboratory accuracy, precision, standardization, and accreditation under the Clinical Laboratory Improvement Act of 1988.
Recently developed automated blood cell counters provide accurate and precise data on complete blood count (CBC). The results of nationwide surveys obtained using them are usually better than those obtained by biochemical tests. The precision of CBC counting has been improved owing to the efforts of laboratories and manufacturers. As for hemoglobinometry, the cyanmethemoglobin and oxyhemoglobin methods used in blood cell counters gave different results for fresh and artificial blood in control surveys. Now instead of the oxyhemoglobin method, the sodium lauryl sulfate-hemoglobin method is used to minimize the variation among different counters. The biggest problem at present is the lack of control blood which can be used for any blood cell counter. Another problem is the laboratory report sent to clinicians, which gives only numerical data. However, other comments and normal reference values should also be presented. Sufficient care may not be taken for normal reference values; they vary considerably among different laboratories. Also, most laboratories and manufacturers now use various conventional units for CBC, but the SI unit should be used for comparison of the data. In conclusion, nationwide unification of CBC values should be established in the near future with cooperative efforts by laboratories and manufacturers.
As the clinical laboratory advances toward total automation, the marketplace is now demanding more-efficient sample-handling systems. These demands have arisen over a relatively short period of time, in part because of heightened concern over laboratory safety and the resulting manpower shortages. Adding sample-handling capabilities to existing instrumentation is often a challenge, because usually mechanical or system constraints are present that interfere. This challenge has been overcome in the DuPont Sample Management System (SMS), a second-generation general chemistry analyzer that incorporates the latest barcode and computer-interfacing technology. The development of the SMS system relies heavily on recent advances in technology, e.g., software modeling and computer-aided design. The SMS system includes a barcode scanner based on "charge-coupled device" technology, a random-access sample wheel, and new software that oversees the various functions.
Our laboratory has developed an automated real-time quantitative PCR assay for detecting human DNA. The assay utilizes an in-house, custom-designed TaqMan-MGB sequence-specific probe (CFS-HumRT) and the ABD 7900HT SDS platform. Developmental validation has followed TWGDAM (1) guidelines and demonstrates that the assay is primate specific, is highly sensitive, yields consistent results, and works with human DNA extracted from a variety of body fluid stains. When operating within the dynamic range of the system using high-quality DNA samples. the technique yields similar quantification results to our current QuantiBlot assay with the added benefit of time saving through automation. Furthermore, the QPCR assay identifies how much amplifiable DNA is in a sample and thus has the potential to predict PCR success in downstream applications such as STR analysis.
PURPOSE: To compare neonatal laboratory results from capillary blood samples drawn using the Tenderfoot automated capillary sampling device with those drawn through arterial catheters. DESIGN: Prospective, paired comparisons of laboratory results from capillary and arterial blood. SAMPLE: Twenty-one infants being cared for in an NICU and having indwelling arterial catheters through which a variety of predominantly glucose-containing fluids were being administered. MAIN OUTCOME VARIABLES: Statistical comparisons of paired capillary and arterial results of pH, PO2, PCO2, lactate, sodium, potassium, ionized calcium, and hematocrit. RESULTS: No capillary-arterial differences were observed for pH, PCO2, lactate, or sodium. Although capillary results were slightly, but significantly (p < .01), higher for potassium (+0.4 mEq/liter), ionized calcium (+0.47 mg/dl), and hematocrit (+4 percent), these differences fell within acceptable Clinical Laboratories Improvement Act (CLIA) performance criteria. Markedly lower PO2 (-30.2 mmHg) and glucose (-61 mg/dl) values were observed with capillary sampling. With the exception of results for PaO2 and plasma glucose, capillary blood drawn using the Tenderfoot automated device yields laboratory results comparable to those from blood drawn from arterial catheters as assessed by CLIA performance criteria.
Diagnosis of antiphospholipid antibody syndrome includes laboratory testing for lupus anticoagulants (LAs). Guidelines for testing have been published, but approaches vary, often incorporating multiple tests. We evaluated the performance of the activated partial thromboplastin time using 2 reagents, a dilute Russell viper venom time, and a hexagonal phospholipid assay for detecting LAs in 105 adults. Of the patients, 26 were taking anticoagulants at the time of testing. Based on findings, an algorithm was derived for optimal detection of LAs using 2 easily performed, automated, integrated test systems. Of 105 patient samples, 30 (28.6%) were positive for LAs, using the algorithm interpretive criteria. Of these 30 positive results, 10 were detected in the 26 patients taking anticoagulants. Analysis by chi2 showed no difference in performance of the integrated tests between samples from patients taking and not taking anticoagulants. The algorithm is offered as a means for standardization of laboratory testing for LAs.
This study assessed the inter-laboratory imprecision associated with the measurement of the endogenous thrombin potential (ETP). The initial studies used techniques that had evolved in each of the participating laboratories. Samples from normal healthy subjects (n = 10), two patients receiving coumarin therapy [International Normalized Ratio approximately 2.0 and approximately 4.0] and a further two subjects receiving treatment with unfractionated heparin (anti-Xa 0.07 i.u./ml and 0.31 i.u./ml) were assayed relative to a lyophilized normal plasma that had arbitrarily been assigned a potency of 100%. Considerable variation in potency estimates was observed between the centres, although individual laboratories using fully automated techniques achieved acceptable levels of imprecision as assessed by the coefficient of variation (CV) (intra-assay CV < 9.5%, inter-assay CV < 12.5%). A second study to assess a similar range of samples, using a standardized assay protocol and incorporating appraisal of two chromogenic substrates, CBS.0068 or Pefachrom TG, demonstrated markedly improved agreement in potency estimates between centres and good correlation (r > 0.96) between the chromogenic substrates. Our data demonstrates that an automated ETP method can be standardized between laboratories and suitable levels of imprecision achieved, using different analysers (COBAS Mira at two centres and an ACL-300R) and two thrombin substrates. This indicates that more widespread use of ETP measurements in clinical laboratories is feasible.
Recent automation in clinical laboratories affords healthcare providers with numerous options in terms of physiological tests. However, the role of the clinical laboratory in the field of equilibrium functional tests is not clearly defined. Therefore, we conducted a questionnaire survey to define the role of clinical laboratories in general hospitals. We present the results of our investigation and the approach employed by the clinical laboratory of our hospital. Rates of healthcare providers desiring the conduct of equilibrium functional tests by clinical laboratories were 78% and 70% in otolaryngology and neurosurgery departments, respectively; moreover, 92% of technologists from clinical laboratories responded that an equilibrium functional test can be performed upon request. Furthermore, 84% of clinical laboratory staff members and 77% of staff from neurosurgery departments agreed that implementation of a system allowing each department to request equilibrium functional tests from the clinical laboratories is necessary. This finding was indicative of the high demand for equilibrium functional tests by clinical laboratories. Therefore, equilibrium functional tests offered by clinical laboratories not only reduce the workload of the otolaryngology department, but also result in a major contribution with respect to management of the entire hospital in terms of high quality examination findings and allocation of healthcare providers in other departments.
This paper briefly describes the history of laboratory systems and discusses some of the recent concepts. The third generation of laboratory systems, which appeared around 1990, encompasses most of the pre-analytical, analytical and post-analytical procedural steps of the laboratory workflow, thus eliminating much of the so-called "3 D tasks" (dull, dirty, dangerous). These automation systems enable humans to focus on work of higher value such as result validation or development of tests in emerging areas. The new development started in Japan in 1981 and reached the Western hemisphere around 1995. Currently there are between 800 and 900 installations world-wide that meet the above criteria. The majority of them automate hematology, whereas systems that automate more complex areas such as clinical chemistry, immunochemistry, coagulation and urinalysis, represent only about one third. More than 60% of the world-wide system base has been installed in Japan. Future growth in the West and high market saturation in Japan are likely to decrease this percentage during the next few years. The two key concepts of third generation systems are "consolidation" and "integration". The following definitions are suggested: * Consolidation: Combining different analytical technologies or strategies on one instrument or on one group of connected instruments. * Integration: Linking analytical instruments or groups of instruments with pre- and post-analytical devices. Examples for the technical realization of both concepts and practical aspects of how to apply them in an individual laboratory are given. Components, which are specifically new in the context of laboratory automation, are conveyor belts, stationary and floor-running robots, and software for process control. The most attractive options to be considered when automating a laboratory are primary tube sorting and the use of secondary samples to increase speed and to avoid sample carryover. Other applications include automatic centrifugation (esp. for hospital laboratories), decapping (esp. for clinical chemistry), automatic loading and unloading of analyzers (esp. for large laboratories), automatic rerun and reflex testing as well as computer-based sample retrieval, result validation, and interpretation. Specific recommendations for automation planning include the need to see and discuss working installations either during site visits or via video documentations, and to conduct computer simulation experiments on the basis of a "virtual laboratory" model.
BACKGROUND: Hemoglobin estimation is the most frequent laboratory investigation requested. Different methods include acid haematin, photometric cyanmethemoglobin estimation and automated estimation with the help of counters. Aims and objectives of the current study were to compare photometric cyanmethemoglobin method with hemoglobin estimation by Medonic automated counter. METHODS: One hundred and ten adult cases were included through convenience sampling. Samples with hemolysis were excluded from the study. Blood was drawn in CP bottles. Sample was thoroughly mixed and hemoglobin estimation was done by Medonic counter as well by photometer 4010. Commercial controls were run with each batch. RESULTS: By manual methods, results revealed mean 0.85% increase compared to automated counter. Commercial control results showed 2.3% and 2.7% coefficient of variation by Medonic counter and photometer 4010 respectively. CONCLUSIONS: It was concluded that both methods are accurate and precise, with reference range 2.61% more in manual method. It is recommended that with small samples and with parameters like hemoglobin or hemoglobin with erythrocyte sedimentation rate, manual method is cost effective and feasible. However with multiple parameters like absolute values and with very large batches, like in tertiary laboratory, automated method is time effective and feasible, provided the laboratory can bear the cost.
Demand for accurate high-throughput detection and characterisation of medically important bacteria has increased dramatically within research and clinical laboratories. Liquid-handling robots have been developed to achieve high levels of accuracy and reproducibility. Assay automation can play a key role in the modern diagnostic laboratory and the data presented here shows that automated PCR is comparable with manual methods. Importantly, automation is preferred when high-quality results cannot be guaranteed using manual methods. This is particularly important when results are required quickly for public health management.