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ABSTRACT: From October 1995 to March 1997, we evaluated five instruments for immunohistochemistry automation: The Techmate 500 (Dako), the Ventana 320/ES (Ventana), the Optimax Plus (Biogenex, Menarini), the Cadenza (Shandon), and the Immunostainer (Coulter-Immunotech). The aim of the evaluation was to compare the different instruments to the manual method in our laboratory which performs about 17 500 immunohistochemistries per year. PRINCIPLE: Three instruments use flat immunohistolabelling, the others use capillarity immunohistolabelling. ANALYTICAL FLEXIBILITY: we compared the number of protocols per run, the multitask capability, and the ability to adapt manual protocols to the different instruments. To compare the management of the workcell, we used the level of selfchecking, reagent and slides preparation time, and waste management. We measured the duration of the different steps of the process, the throughput in slides/h, and the operator working time per slide. Compared to the manual method, the total cost for reagents and consumables was found to be multiplied by 3 for the Ventana which is a closed system, by 2 for the Techmate, by 1.5 for the Optimax and Cadenza, and identical for the Immunostainer. CONCLUSION: Automation of immunohistochemistry is now possible; the Optimax is still in development, small laboratories will appreciate the Cadenza, laboratories requiring a high flexibility with many protocols will use the Immunostainer open system, laboratories with few technicians will prefer the Ventana closed instrument, now available as the Nexes modular system.
Clinica Chimica Acta 01/1999; 278(2):185-92. · 2.54 Impact Factor
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ABSTRACT: To face the rapid evolution of the clinical laboratory activity from sample analysis towards an in-vitro diagnostic network, a Total Quality Management system must be implemented by laboratory professionals. Technological advances make it possible to introduce new tools and techniques for many issues surrounding the analytical process, as has happened for analysis automation and laboratory management. Preanalytical steps should benefit from extended traceability, using new identification devices such as electronic labels. This may promote the improvement of sample handling in this phase, such as during transportation or centrifugation. Another field is the expansion of metrology. Many factors can now easily be controlled in the clinical laboratory. New reliable automated systems are available to evaluate the performance of pipetting devices. Autonomous miniaturized recorders and probes connected to monitoring softwares allow traceable temperature monitoring. In this paper, some examples are presented to illustrate how technical solutions can support the implementation of Quality Assurance in the clinical laboratory.
Clinica Chimica Acta 01/1999; 278(2):103-10. · 2.54 Impact Factor
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ABSTRACT: The introduction of immunochemical techniques into the routine pathology laboratory has significantly expanded the capabilities of the pathologist in diagnostic procedures. Immunostaining represents a powerful diagnostic tool in the identification and localization of cellular antigens, in paraffin sections, frozen tissues and cell preparations. The labeled-streptavidin-biotin method provides excellent sensitivity and performance. This multistep procedure includes: incubation of the slide with primary antibody, reaction with the biotinylated secondary antibody, binding with an enzyme conjugated streptavidin and revelation with chromogen substrate. Evaluation of the finished product is directly dependent on the quality of the technique. The main critical steps of this manual method are reagents application, incubation times and rinsing. These steps could be accessible to automation. Automation in immunohistochemistry could guarantee a continuous quality of labelling in improving standardisation, optimization and traceability of operations. The required qualifications are analytical flexibility, low cost, walkaway operation, user-friendly interface and biosafety.
Clinica Chimica Acta 01/1999; 278(2):177-84. · 2.54 Impact Factor
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ABSTRACT: All cancer staging systems seek to identify clinical and pathological features that can predict outcome or guide therapy. In particular, a non-invasive method for the early detection of disseminating disease would be of great interest. We investigated the use of cytokeratin genes expression to detect blood metastases from colorectal tumors. Epithelial tumor cells were isolated from whole blood using the monoclonal antibody (MAb) BerEP4 and magnetic beads, and detected by reverse transcription-polymerase chain reaction using oligonucleotides derived from the cDNA sequences of cytokeratins 8, 19 and 20. The sensitivity of this assay was determined by spiking SW620 colon carcinoma cells in normal blood. Using cytokeratin 19 expression we were able to detect 1 epithelial tumor cell in 1 ml of whole blood. The clinical applicability of this technique was explored by evaluating patients with a colorectal carcinoma. Epithelial cells were detected in the blood of 12 out of 23 patients, 2 (20%) of 10 with Astler-Coller stage A or B, and 10 (77%) of 13 with stage C or D cancer. In conclusion, this test is a non-invasive, sensitive, and specific assay for detecting circulating epithelial cells in blood. It may be useful for the early diagnosis of disseminating disease, to determine whether the presence of micrometastatic cells at the time of surgery is correlated with an early relapse and for monitoring adjuvant therapeutic trials.
International Journal of Cancer 11/1997; 74(5):540-4. · 5.44 Impact Factor
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ABSTRACT: 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.
Clinical Chemistry 10/1997; 43(9):1709-15. · 7.91 Impact Factor
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Clinical Biochemistry 05/1996; 29(2):171-3. · 2.08 Impact Factor
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ABSTRACT: Practice of Point of Care Testing in medical care centre is very unequal in France despite official guidelines of governmental agencies and laboratory professionals. Last years, a lot of advances in devices technology have been performed particularly in term of connectivity, quality control and traceability with apparition of new global solutions. These possibilities open new perspectives in point of care testing organization in France. We suggest an overall view with the introduction of a coordinator of all point of care testing to coordinate the different actors at every step of the project, from decision to installation of the chosen solutions.
ITBM-RBM.
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Annales de biologie clinique 61(2):159-63. · 0.34 Impact Factor
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Annales de biologie clinique 58(4):491-5. · 0.34 Impact Factor
