Clinical Laboratory Automation: The New Normal

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 Clinical Laboratory Automation: The New Normal

Technology Spotlight

Please see our Liquid Handling Robotics (Automated Systems) and Immunoassay Analyzer sections to find manufacturers that sell these products

Automated production in the manufacturing sector has been the norm for many years, and has led to vastly improved products with far fewer defects, along with considerable positive returns in profit and productivity. Automation is now also required to preserve quality and efficiency in the clinical laboratory.

Automation of Specimen Processing

Preanalytical automation was developed to deal with increased workloads and a workforce reduced because of budget cutbacks. It assists with specimen processing, which includes sorting, decapping, placing sample tubes in racks that may originate from a wide range of manufacturers, aliquoting, centrifuging, and delivery to the correct analytical station in the laboratory. Preanalytical automation provides an additional benefit, in that over half of laboratory errors occur during the front end of the test cycle.

Preanalytical automation is available in two general formats: distinct workcells that perform a limited number of jobs (e.g., tube sorting) and are standalone devices, or systems. Workcells are often designed to be incorporated into systems.

  • Abbott Diagnostics (Abbott Park, IL) offers the ACCELERATOR® Systems, which include the ACCELERATOR p540, a standalone device; the ACCELERATOR Automated Processing system, which offers a configurable track, process decapping, testing and resealing, and interchangeable modules to best fit the immunoassay and clinical chemistry needs of each laboratory; and the next-generation laboratory automation track system, the ACCELERATOR a3600, which can process up to 3600 samples per hour and handle multiple tube sizes and types simultaneously. Because of its modular design, it enables the installation of up to 99 combined analyzers and modules on a single system. The system is designed to automate pre- and postanalytical processing and sample handling.
  • The Tecan Group, Ltd. (Männedorf, Switzerland) offers the FE500pro™, a front-end preanalytical laboratory solution that combines all preanalytical functions on a small-footprint instrument, including presorting, centrifugation, volume check and clot detection, decapping, secondary tube labeling, aliquoting, and destination sorting into analyzer racks. This system handles 500 tubes per hour and is easily reconfigured for a mix of clinical chemistry, immunoassay, hematology, and other specimen tubes.
  • Siemens Healthcare Diagnostics (Deerfield, IL) offers a range of laboratory automation solutions that include preanalytical components such as the ADVIA® Centrifuge Module. It has a capacity of 1–72 tubes per cycle, and can process up to 300 tubes per hour. It can process STAT and routine samples in intermixed tubes and caps with minimal attention or intervention by the operator, and can route tubes based on spin requirements. It is designed to easily integrate with the entire suite of ADVIA automation solutions, ensuring streamlined preanalytical, analytical, and postanalytical workflow.

Automated Test Options Will Include Molecular Analysis

Many clinical labs worldwide are converting to total laboratory automation, based on strong evidence that automation not only heightens profitability but also improves quality, timeliness, and lab flexibility. Over 80% of hematology and routine clinical chemistry can now be completely automatically analyzed. Development of automation is still needed in infectious disease and molecular diagnostics. Because sequence analysis will be increasingly necessary, there is a move to develop automated workcells that perform nucleic acid extraction and analytics, and some are available.

  • The U.S. division of the Japanese conglomerate Olympus, the Olympus Diagnostic Systems Group (Melville, NY) offers the OLA4000™ workcell lab automation system, which is a workcell laboratory automation solution designed for medium- and high-volume hospital and commercial reference laboratories. This system fully automates labor-intensive specimen processing tasks within the chemistry-immunochemistry work area, including sample identification, centrifugation, decapping, and output sorting of specimen tubes. It also integrates two Olympus AU analyzers for automated rack loading and unloading along with centralized data processing. The throughput is 400 tubes per hour for preanalytical processes. The system uses high-speed robotics and Windows NT® operating software. A specimen tracking feature enables quick identification of samples while reducing biohazards for laboratory personnel. The flexible, modular design of the OLA4000 allows it to be fully integrated with any combination of two Olympus AU640™ and AU2700™ chemistry-immuno systems. The workcell solution integrates the analyzers into a single-user interface for the entire sample testing process.
  • Siemens Healthcare Diagnostics (Deerfield, IL) offers a range of analytical automation solutions for chemistry and/or immunoassay automation. ADVIA Automation solutions is a multidiscipline system offering high capacity and increased throughput, and fully integrates with specimen processing management, centrifugation, and decapping. StreamLAB® Automation Solutions allows a streamlined workflow by automating manual steps with highly flexible, compact configurations for efficient space utilization and minimal lab disruption during implementation. Aptio™ Automation is a unified solution developed expressly for the changing workload and expanding needs of the clinical laboratory. It combines peak performance, adaptability, and intelligent technology with maximized automated workflow. The VersaCell® System provides a unique sample management technology that works differently from other systems to increase workflow efficiency for chemistry and/or immunoassay testing.
  • BD Diagnostics (Sparks, MD) offers the BD MAX™ System, which provides fully automated testing for molecular diagnostics. Enabling walk-away and on-demand workflow, the system fully automates cell lysis; nucleic acid extraction; and PCR setup, amplification, and detection. Its features include the ability to perform multiple assays and multiple specimen types simultaneously, run up to 24 samples simultaneously, and provide on-demand capability. BD Diagnostics offers the FDA-cleared MD MAX GBS assay, which is run on the BD MAX and detects Group B Streptococcus DNA in Lim Broth cultures obtained from vaginal/rectal swab specimens from antepartum pregnant women. In addition, the company offers BD MAX Open System Reagents, which consist of multiple-sample-type extraction reagents for DNA and RNA. The BD MAX System is also cleared or approved by the FDA when used with BD MAX IVD assays that have been cleared or approved by the FDA.

Please see our Liquid Handling Robotics (Automated Systems)  and Immunoassay Analyzer sections to find manufacturers that sell these products