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Use of laboratory instruments and specimen processing equipment to perform clinical laboratory assays with only minimal involvement of technologist .

Automation in clinical laboratory is a process by which analytical instruments perform many tests with the least involvement of an analyst.

The International Union of Pure and Applied Chemistry (IUPAC) define automation as "The replacement of human manipulative effort and facilities in the performance of a given process by mechanical and instrumental devices that are regulated by feedback of information so that an apparatus is self-monitoring or self adjusting”.

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  1. 1. Automation in Clinical Chemistry Tapeshwar Yadav (Lecturer) BMLT, DNHE, M.Sc. Medical Biochemistry
  2. 2. What is Automation Use of laboratory instruments and specimen processing equipment to perform clinical laboratory assays with only minimal involvement of technologist .  Automation in clinical laboratory is a process by which analytical instruments perform many tests with the least involvement of an analyst.  The International Union of Pure and Applied Chemistry (IUPAC) define automation as "The replacement of human manipulative effort and facilities in the performance of a given process by mechanical and instrumental devices that are regulated by feedback of information so that an apparatus is self-monitoring or self adjusting”.
  3. 3. History  Began-1950  Escalation of Demand for test.  Larger work loads : -Increase in 15 % /Annual -Doubling- 5 Yrs. How to handle ?  Increase in Staff  Improvement in Methods  Use of Automation. Shortage of trained technicians- Work simplification Manual- Machine (Various stages of Analytical Procedures)
  4. 4. Evolution  Fixed Automation-repetitive task by itself  Programmable Automation-Variety of different tasks.  Intelligent Automation-Self monitoring and appropriate response to changing condition. Historical Overview: Incremental – over 50 year Key to success:  Incorporation of  continuous flow  Discrete processing step  Development:  LIS  Robotics  Concept of total and modular automation
  5. 5. Automations Extending:  Processing and transport of specimens  Loading in to analyze  Assessing the results
  6. 6. Processes used in Automation  Continuous flow  Discrete Processing
  7. 7. Continuous flow analysis: By:Leonard skeggs in 1950 • Pioneered device  Single-channel  Continuous flow  Batch analyzer Throughput: 40-60 specimen/hour One result /analyte for each specimen
  8. 8.  Reaction - Tubing (Flow container & Cuvet)  Specimen reagent mixing – roller pump (Assay Specifics)  Volume control –Different internal diameter of pumping tubes  Mixing – Through Coils.  Minimizing Carryover – Injection of air bubbles into specimen stream  Temperature control –water bath  Timing reaction –Distance the stream Travelled.  Provision of Protein free filtrate- Dialyzers  Mainstay – for > 20 years  2nd and 3rd - Generation (Multiple test result on same specimen)
  9. 9. Discrete analysis: (1970) Widely used  Each specimen in a batch – “Separate from every other specimens” Discrete processing is used by-  Centrifugal  Random access Analyzer
  10. 10. Centrifugal Analyzers:  1970 –Norman Anderson  Oak Ridge National laboratory-US
  11. 11. What happens : Discrete aliquots of specimen & Reagent Pipetted Discrete chambers in a Rotor Spinning of rotor Centrifugal force Transfer & mix aliquots specimen/reagent Cuvet (radially located) Rotator motion (Move- Cuvet) Optical path Integration computer system Multiple absorbance reading software Enzyme Activity (Substrate concentration)
  12. 12. Early analyzers:  Analysis of Multiple specimens for single analyte in parallel. Later: (Selection of Different wave length)  Several analysis in parallels at different wave length  Rotor: - Specimens of several tests at same time. -Scheduled of appropriate tests (keyboard entry bar coded label).
  13. 13. Random access analyzer:  Sequential Analysis on Batch of specimens. (Each specimen different tests.)  Measurement of Variable No. and varieties of Analytes in each specimen. (Profiles of Groups of Test)
  14. 14. Tests are defined:  Keyboard  LIS with conjunction with Barcode Selection of Appropriate Reagent Packs Absorbance Measurement- Computer Incorporation- “ Walk away “- Instruments can be left for a brief period.  Software programming. (Single Technician – can operate more than one analyzer at a time.)
  15. 15.  Most current chemistry and Immunoassay analyzers are Random access. Steady Improvement -Mechanical reliability. -Software technology Easy Operation
  16. 16. Types of Automation  Total  Modular Total Laboratory Automation (TLA). Early model 1980 Kochi Medical School.  Nankoku,Japan-Dr Mesahide Sasaki. Samples: Conveyer belts – carriers  Work station.  Automated pipette.  Required lab test.
  17. 17.  Total Lab Automation:  Large lab  Large scale -very expensive. Pre-analytical automation functions.  Centrifugation.  Aspiration of serum.  De-capping of tubes.  Splitting of specimen  Barcode of aliquot tubes.  Sorting of tubes. Transport system.  Conveyor belt Tube recapping machine Storage system.
  18. 18. Modular Automation (1990)  Selected Modules -Analyzers -ISE  Marketed successfully  LAS (Laboratory Automation System).  TLA Require extensive software  Module.
  19. 19. Steps in Analytical Processes  Individual steps – “Unit operations”  Specimen acquisition  Specimen Identification.  Specimen delivery to lab.  Specimen preparation.  Specimen Loading and aspiration.  On – analyzer specimen delivery.  Reagent handling and storage.  Reagent delivery.  Chemical reaction Phase.  Measurement approaches.  Signal processing , data handling and process control.  In most – Sequential.  In some – Combined & Parallel.
  20. 20. Specimen Acquisition.  Sample collection- Automation (In process of Development)  Zivonovic and Davis –Robotic System. -Flat headed probe – location of vein. -Automatic needle withdrawal.
  21. 21. Specimen Identification  Identifying link  Maintained throughout -Transport -Analysis -Reporting.  Technology: Labeling , Bar-coding ,Optical character recognition. Magnetic stripe, Radio frequency identification. Touch screen, Optical Mark Reader, Etc.  Bar-coding – Technology of choice.
  22. 22. Labeling • Test order • Electronic Entry • Generating Unique identity of specimen • Unique lab accession number • Records • Till reporting
  23. 23. • Labeling of tubes • Critical for processing • Log in procedures • Technical handling • Secondary labeling (If needed)
  24. 24. Bar-coding • Major automation of specimen identification • LIS • Bar-coded label • Specimen container • Read-Barcode reader • Identification information (By software)
  25. 25. Advantages • Elimination of work list on the system. • Prevention of mixed-up of tubes placements. • Analysis of specimen in defined sequences. • Avoiding tube mix-up –in case of serum transfer • Auto discrimination • Operator intervention is less. • Ensures- integrity of the specimen identity.
  26. 26. Specimen delivery to lab • Courier • Pneumatic tube system • Electric track vehicles • Mobile robots COURIER: • Human courier • Batch process • Specified timings • Delay in Services • Specimen loss . Etc..
  27. 27. Pneumatic- Tube system • Rapid transport • Reliable • Point to point services • Mechanical problem • Damage of specimen • Limited carrying capacity • Cost effective Electric track vehicle: • Larger capacity • No specimen damages • Larger stations • ?Rapid specimen transport Mobile Robots: • Studies- Establish usefulness • Delays • Batched pick up. etc, • Cost effective
  28. 28. Specimen Preparation • Clotting of blood • Centrifugation (Serum) Time Consuming - Delays • Secondary tube Developments- Note worthing • Use of whole blood 1.Assay system-Analyzer whole blood • Specimen preparation time-Elimination Eg. ISE- with in minutes 2.Application of whole blood to dry reagent films. • Visual • Instrumental observation (Quantitative)
  29. 29. Specimen loading and aspiration Specimen- Serum/ Plasma -Primary collection tubes -Sample cups -Secondary tubes 1.Evaporation of Specimens (Cups- 50 % over 4 hrs) Analytical errors- -Loading zone-covered -Cups-Paraffine film /caps. 2.Thermal /Photo degradation Temperature labile-Refrigeration loading zone Photo labile –Semi opaque containers
  30. 30. Loading Zone- Areas of specimen holding- • Circular tray • Rack/ Series of racks • Serpentine chain No Automatic specimen identification • Loading of Specimens- correct sequence as per loading list Automatic Specimen Identification- Reposition of Specimens Loading- Second run (Separate tray) Optimal Efficiency Provision of Continuous loading. Ideal/ Desirable features: (STAT Mode) • New sample insertion at anytime/ all the times. Ahead of already running sample • Timely analysis -Emergency samples.
  31. 31. Transmission of Infections Disease • Common concern 1.Splatter-Acquisilion by Specimen probes Prevention -Level Sensors -Restriction of Penetration -Smother motion control 2.Aerosols- -Potential for contamination -Specimen Transfer -Spillages • Prevention- Closed Container -Sampling system.
  32. 32. Specimen Delivery Continuous flow Sample probe Continuous reagent stream Discrete analyzer Sample Probe Reaction cup
  33. 33. Discrete Pipetting • Positive –Liquid-Displacement pipette • Specimens/Calibration/Controls Operational Modes: 1. To dispense only aspirates specimen in to reaction receptacle. 2. To flush out specimen together with diluents. 3. Plastic or glass syringe with plunges (Teflon)
  34. 34. Displacement Medium Liquid-(Diluents or reagent) -Highly reproducible measurement. Air: Less accuracy (Viscous fluid) Lipaemia/ Hyper protinemia. Categorization: -Fixed -Variable -Selectable- Predetermined volumes widely used in systems. Inaccuracy/ Imprecision-Not >1 %(Specimen and Reagent) Periodic Verification of Accuracy & reproducibility. Delivery of Specimens- Built -in Conveyor Track or Specimen Carrier (Robotic)
  35. 35. Carry over- ”Unintended transfer of a quantity of analyze or reagent by an analytical system from one reaction into sub sequent one” “ Error in analysis” Protocols to minimize • Adequate flush to specimen ratio-4: 1 (Wash station /Sample probe) . • Choice of sample probe materials . • Surface conditions • Flushing internal/ External surface of sample probe. • Wiping of outside. • Disposable sample probe tips for the Pipetic Systems • Stringent requirement- For Immunoassays. -Additional washes /devices. -Additional rinsing function
  36. 36. Reagent Handling and Storage • Liquid reagents-Plastic/glass containers. • System Packs-No refill • Mostly single reagent • Impregnated slides/Strips • Electrodes Storage • Refrigeration • Reagent storage compartment(40- 100 C) • Stable 2-12 months.
  37. 37. Liquid Reagent system: • Large volume –Adequate for operation • Container- Reagent (Test by Test) • Limited stability- Preparation (fresh) Non-Liquid Reagent System: • No/Very little liquid • Dry systems- Multilayered slides-Reagent emulsions Multilayered film chip-Reagent impregnation. Reusable Reagents -Immobilization in reaction coil or chamber. -Immobilization of enzymes on membrane –Buffer - wash solution
  38. 38. Reagent Identification Labels- Reagent Name • Volume • No. of tests • Expiry Date • Lot No. Barcodes: 1.Facilitation of inventory management 2.Insertion of reagent container in random sequence. 3.Automatically dispense a particular volume of liquid reagent. • In immunoassay system- Key information –Calibrators.
  39. 39. Open Vs Closed Systems Open- Reagent from variety of Suppliers • Flexibility • Ready adaptation • Less expensive • Longer open stability Closed: • Reagent –Unique container • Formats by manufacturer • Hidden cost advantage • Avoidance of variability arising from reconstitution of reagent. • Open variable stability short. Most Immunoassay system -Closed
  40. 40. Reagent Delivery Liquid Reagent Pumps (Through tubes) + ve displacement syringes devises. Mixing and reaction chambers Pumps: • Peristaltic pumps -Compressing and releasing of reagent tubes. -Deliver the fluids. -Determination of the proportion of reagent to specimen. • Syringes Devices- Reagent and Specimen common + ve displacement. Volumes –Programmable. Reproducible ±1 % • Washing and Flushing facility.
  41. 41. Chemical Reaction Phase • Chemical Reaction=Specimen + Reagent Issues of concern in designing Analyzer. 1.Vessel- Reaction occurs, -Cuvet- reaction monitored. 2.Timing of reaction 3.Mixing and transport of reactants . 4.Thermal conditioning of fluids. Types of reaction vessels and cuvet: • Continuous flow systems- Tube- Flow container - Cuvet • Discrete Systems
  42. 42. Discrete System • Each specimen- Separate Physical - Chemical space 1. Individual (Dispensable/Reusable) Reaction vessels. -Transported 2. Stationary reaction chamber Cuvets – Reusable / Disposable -Simplification -Avoid carry over -Superior plastic (Acrylic & polyvinyl chloride)
  43. 43. Requirement • Large scale production • Excellent dimensional tolerance • Must be transparent in spectral range. Reusable reaction Vessels • B &C Synchron • Abott • Olympus Periodic replacement –Composition • 1 month- Plastic • 2 yrs- Std glass • If Physically Damaged–Pyrex glass
  44. 44. Cleaning Cuvets Wash station –Aspiration of reaction mixture • Detergent –Alkaline -acid wash • Repeated Dispension/Aspiration • Rinsing- Deionizer. • Drying –Vacuum , Pressurized Air. Optical Clarity is verified • Unsatisfacting -Flagging - Replacement Reusable Cuvets: Economical Increased complexity Requirement of cleaning liquids Centaur- Individual cuvet 200-1000 can be loaded. Dimensions- Manufacturer by instrument surlyn clear plastic.
  45. 45. Timing of Reaction Rate of Transport-Measurement station • Timed events of reagent additive or activation. Discrete systems • Addition of specimen & reagents at timed sequence. Absorbance at intervals Timings- Defined by Manufacturer Mixing of Reactants • Forceful dispensing • Magnetic stirring • Rotating paddle • Use of ultrasonic energy Mixing –Difficult to automate.
  46. 46. Thermal Regulation 370 C • Controlled –Temperature Environment • Close contract to reaction container • Efficient heat transfer environment- Reaction mixture. • Air Baths • Water Baths • Cooling plate
  47. 47. Measurement Approaches Chemistry Analyzer- - Photometers -Spectrophotometer Alternative Approaches- - Reflectance Photometry -Fluorometry Immunoassay: -Florescence -Chemilluminiscence -Electro chemilluminiscence Electrolytes: • ISE- Electrochemical
  48. 48. Signal Processing, Data Handling and Process Control Computers-Integral Components -Analysis -Reporting Process -Control of Data inputs -Monitoring -Data Reporting • Work Station- Integration Interphasing of individual Analyzer. Acquisition • Processing of Analytical Data • Software (Sophisticated)
  49. 49. 1.Command and Phase the electromechanical operations • Transfer of Solution • Placement of proper filter • Regulation of speed of rotation 2.Operational features: • Calculation of results • Increase Reproducibility 3.Acquire, assess, process and store operational data Communication integrations between analyzer & operator • Replenish reagents • Empty waste container • Warn operating problems • Status of every specimen Flagging • Exceeding of Linearity • Sub strata exhaustion • Absorbance problem 4. Interfacing Facility 5.Computers incorporated into instruments- Special Capability. QC Calibration curves.
  50. 50. Computer Work station • Monitoring & Integration • Accept test order, • Monitoring of testing process • Assisting with process quality • Review and verification of results. • Display of L J Chart. • Troubleshoot monitoring • Auto verification of results.
  51. 51. Questions in our Mind  Increase in our work load ?  Tackling increase work load ?  Quality Result Reporting ?  Error Prevention ?  Complete control ?  Improve TAT ?  Adding new assays ?  Stream lining the processes ?  Improving Services ?  Over coming shortage of trained technicians ? Single Answer is -Automation
  52. 52. Benefits:  Reduction - variability of results -Errors of analysis  Avoidance- -Manual- boredom or inattention Improved reproducibility-Quality improvement  Skill fully designed automated instrument  Good analytical methods  Effective QA program  Cost Effectiveness
  53. 53. Ten Reasons why Automation Fails to Meet Expectations • Incomplete understanding of current environment, processes, cost, customer expectation. • Loss in flexibility because of fixed process and limited throughput • Unrealistic Expectations of system-Cost reduction, throughput returns on investment. • Unplanned and poorly developed “work around” require to interfere automation with manual processes. • Unclear expectation s of system functionality.
  54. 54. • Over build and Unnecessarily complicated system design. • Inadequate technical support • Credible and realistic impact analysis never conducted. • Hidden costs-Labor, supplies, maintenance • Failure to optimize current processes before automation (Never automate a poor process)
  55. 55. “Let us Thank All the Brains Behind Automation “ For Making Our job Easy and Pleasurable and our life Peaceful ……