CC LEC M3 U5

• Automation of analytical processes in clinical chemistry involves the mechanization of steps in a procedure, with unit operations like specimen identification, delivery, preparation, loading, processing, reagent handling, chemical reactions, measurement approaches, and data handling

  
• In automated analyzers, specimen identification ensures proper monitoring of the sample throughout the test, often using bar code labels for patient demographics and test requests
• Advantages of bar coding in specimen identification include efficient tracking, reducing errors, and enabling quick transfer of identifying information to system software
• Other techniques for automated specimen identification include optical character recognition, magnetic stripe readers, voice identification, radio frequency identification, touch screens, light pens, hand print tablets, optical mark readers, and smart cards
• Specimen delivery methods in laboratories include courier service, pneumatic tube systems, electric track vehicles, and mobile robots, each with its advantages and drawbacks
• Specimen preparation in automated systems can involve primary tube sampling, where the separated serum or plasma sample is directly used for analysis without further transferring
• Specimen measurement and internal delivery in automated analyzers often use circular carousels, quadrant trays, or rectangular racks to hold sample cups or tubes for pipetting into reaction chambers
• Measurement of each aliquot for each test in automated analyzers is done through aspiration of the sample into a probe, with specific depths programmed for optimal sample use
• Reagent handling in automated analyzers varies according to the instrument's capabilities, ensuring precise delivery and mixing of reagents for accurate testing
• Processes in automated analyzers include centrifugal analysis, which uses centrifugation force to transfer and contain liquids in separate cuvettes for measurement, and discrete analysis, where each sample and reagents are separated in separate containers for testing
• Centrifugal analyzers excel in batch analysis, reading reactions in all cuvettes simultaneously, while discrete analyzers can run multiple tests one sample at a time or multiple samples one test at a time
• Discrete analyzers are versatile and have replaced continuous-flow and centrifugal analyzers, requiring uniform quality maintenance in each cuvette to ensure accurate results
• Drawbacks of using courier services for specimen delivery include potential misrouting of carriers, hemolysis risks, and the need for careful design to prevent specimen damage
• The most sophisticated approach in sample identification commonly uses bar code labels on primary collection tubes for efficient tracking and transfer of identifying information to system software
• Automated specimen identification techniques also include optical character recognition, magnetic stripe readers, voice identification, radio frequency identification, touch screens, and more
• Specimen delivery methods in laboratories include courier service, pneumatic tube systems, electric track vehicles, and mobile robots, each with unique advantages and challenges
• Reagent systems and internal delivery:

  • Reagents may be liquid or dry systems
  • Liquid reagents are acquired and delivered to mixing and reaction chambers by pumps or positive-displacement syringe devices
  • Dry reagents are lyophilized powder that requires reconstitution with water or a buffer
  • Some analyzers use multilayered dry chemistry slides for specific technologies like the Vitros analyzer
• To preserve reagents, modern automated instruments may:

  • Keep all reagents refrigerated until needed
  • Provide reagents in a dried, tablet form to reconstitute when the test is run
  • Manufacture reagents in two stable compartments that combine at the moment of reaction
• In the chemical reaction phase:

  • Mixing techniques vary, from coiled tubing in continuous flow analyzers to stirring paddles in wet chemistry analyzers
  • Separation methods differ, with some systems using dialyzers or membranes to filter out interfering substances
  • Incubation involves maintaining the reaction mixture at a constant temperature for color development
  • Reaction time allows the chemical reaction to take place, and the rate of the reaction can be monitored in automated systems
• Factors affecting the chemical reaction phase of automated analytical processes:

  • Rate of transport through the system
  • Timed reagent additions
  • Type of reaction chambers used
• Measurement phase:

  • Quantification of formed products using optical measurement devices like photometers, spectrophotometers, and more
  • Ion-selective electrodes and electrochemical techniques are also widely used
• Signal processing and data handling:

  • Estimation of analyte concentration using a calibration curve stored in the analyzer
  • Functions include signal acquisition, averaging, correction for interferences, and computation of rate reactions
• Sending results to the laboratory information system (LIS):

  • The analyzer communicates results to the LIS, which manages and stores data for clinical laboratories
  • LIS functions include generating orders, monitoring sample status, interfacing with analyzers, archiving results, and more
• Total Laboratory Automation (TLA):

  • The concept of totally automating a clinical laboratory began in Japan in the early 1980s
  • Early designs used robots, conveyor belts, and modifications to existing analyzers to perform pre-analytic and analytic tasks with minimal human intervention
• Total Laboratory Automation (TLA) systems are designed for hospital-based laboratories and automate a large percentage of laboratory work
• TLA labs are considered "Black Box" labs where samples go in at one end and the printed result comes out at the other end
• TLA labs consist of three components: front-end systems for pre-analytic phase/sample processing, analytic "Box" for chemical analyses, and back-end systems for post-analytic phase/data management
• Technical difficulties/challenges to TLA include financial investment, skilled technical personnel, remodeling of laboratory infrastructure, software interfacing, and limitations in processing stat samples
• Automation in clinical laboratories increases test efficiency, minimizes errors, reduces workload, and improves accuracy and reproducibility
• Automation in clinical laboratories can be seen from patient identification to report delivery, with analyzers becoming faster, more precise, and easier to use
• Automation in clinical laboratories is driven by factors like turnaround time demands, specimen integrity, staff shortages, economic factors, and the need for reduced errors
• Automation in clinical laboratories is continually evolving to meet regulatory standards, improve accuracy, and enhance efficiency through innovative technologies and features
• Automation in clinical laboratories is essential for meeting quality standards and demands for faster, more accurate testing with fewer errors
• Automation in clinical laboratories is not expected to eliminate the Medical Laboratory Science profession but rather enhance efficiency and accuracy in testing processes