[Show abstract][Hide abstract] ABSTRACT: The KRYPTOR compact (CEZANNE SAS) is an innovative automated immunoassay system using a homogeneous technology avoiding separation and washing steps. The main innovation of the KRYPTOR compact is the modular design of the instrument including two separable parts: a pipeting module and a reading module. The transportable reagents cassette includes an original cooling system activated when it is on board. The system is selfchecking, reagents are precalibrated with only two points of verification by the user, fast and easy to maintain. A first multisites evaluation of the analytical performances and practicability proved the ability of this system to answer well to laboratories that demand special parameters with a medium or smaller throughput such as urgent requests or highly specialized activities.
Journal of the Association for Laboratory Automation 02/2009; 14(1):41-48. DOI:10.1016/j.jala.2008.04.010 · 1.50 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The aim of this study is to secure clinical trial drugs shipping from a coordinator pharmacy to hospital pharmacies of investigator centers in France. The monitoring of each parcel temperature during shipping using an autonomous temperature logger has been decided. In order to validate this concept, a prior qualification of parts composing the parcel has been realised. Moreover, tests have been realised to design the parcel and the necessary cold environment for good shipping conditions. The result is a parcel able to maintain the temperature between + 3°C and + 24°C during 24 hours at an external temperature of + 50°C. The different parts of the parcel have been qualified and documented with procedures and quality documents. Then, the parcel configuration has been adjusted with the result of temperature loggers because of seasonal temperature variations.
Le Pharmacien Hospitalier 06/2007; 42(169):61–68. DOI:10.1016/S0768-9179(07)90065-6
[Show abstract][Hide abstract] 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.
[Show abstract][Hide abstract] ABSTRACT: A new multicapillary zone electrophoresis instrument, the Capillarys, was recently launched by Sebia Company. We integrated the Capillarys in an automated workcell that is able to pick tubes from a sample transportation system and arrange them in the right position for bar code reading on the racks of the Capillarys. The racks are transported and loaded on the Capillarys by the robot. After analysis, racks are automatically collected and transferred to a stacker, to wait for storage, waste management, or transportation to another instrument. We built a prototype, and to validate the workcell, we performed a Qualification Plan. The various tests did not reveal important errors in the design of the prototype, but some slight defects in safety, materials, and software were identified. The final decision was to validate the Qualification. The method of Qualification was found to be very efficient for evaluation of the prototype and early detection of necessary improvements. As a result, the risk of modifications required in customer laboratories was limited.
Journal of the Association for Laboratory Automation 02/2005; 10(1):54-58. DOI:10.1016/j.jala.2004.11.005 · 1.50 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Robotic laboratory equipment malfunctions may affect the performance of integrated laboratory instruments. Thus, the qualification of robotics is necessary to ensure adequate performance of complete integrated systems. In this JALA Tutorial, we adapt the methods used in production processes to laboratory robotics and propose guidelines for performing the various steps required for qualification (i.e., installation, operational, and performance qualification), while emphasizing specific aspects of laboratory robotics. We think that the application of such guidelines will help in standardizing the acceptance of robotic equipment, facilitate their operation and performance evaluation, and improve traceability with quality assurance documentation.
Journal of the Association for Laboratory Automation 02/2005; 10(1):48-53. DOI:10.1016/j.jala.2004.11.004 · 1.50 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Automated cell culture incubators generally are considered primary components of fully automated cell culture systems, which are able to monitor cell growth without human interaction. This tutorial is focused on automated cell culture incubators. It emphasizes the impact of automation on throughput and environmental controls (temperature, humidity, and CO2) and proposes some basic protocols to check these functions. In addition, it details practical aspects for switching from manual to automated cell culture incubators.
Journal of the Association for Laboratory Automation 12/2003; 8(6):82-86. DOI:10.1016/S1535-5535(03)00018-2 · 1.50 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: We evaluated the benefits of automation on the technical performance of a new automated cell culture incubator, the Autocell 200®, developed by Jouan SA. In addition, we assessed the potential interference of the embedded mechanical parts on cell culture growth. We measured a throughput of 150 plates loaded per hour, and 120 plates unloaded per hour, which is compatible with an external robotic handler. The mean time of robotic gate opening was 7 s. The gate pathway minimized climate disturbances inside the incubator. For CO2, we used a delay between opening events of 1 min. Biological assay results did not demonstrate a significant difference between the automated incubator and a traditional manual incubator, but we concluded that automation using the Autocell 200® could provide meaningful benefits for cell culture.
Journal of the Association for Laboratory Automation 12/2003; 8(6):87-95. DOI:10.1016/S1535-5535(03)00024-8 · 1.50 Impact Factor
[Show abstract][Hide abstract] 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.
[Show abstract][Hide abstract] 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.
[Show abstract][Hide abstract] 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.
[Show abstract][Hide abstract] 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.