Miswar Fattah, M.Si Makassar, 6 Juni 1978 Education 1997 : SMAK Depkes Makassar 2002 : Chemistry - University of Hasanuddin 2006 : Clinical Chemistry, Biomedic- University of Hasanuddin Current position Research & Esoteric laboratory Head, Prodia Clinical Laboratory Molecular Diagnostic Scientist, R&D Prodia Clinical Laboratory Scientific division of Molecular Diagnostic , Indonesian Association for Clinical Chemistry International Relationship departemen PATELKI PATELKI Miswar Fattah, Msi TOT Bandung , 27 November 2011 PATELKI Term of automation Concept automation in clinical laboratory medicine : a history Current concept in automation of laboratory medicine Impact automation in medical technologist & Regulation PATELKI Automation is the use of control systems and information technologies to reduce the need for human work in the production of goods and services Laboratory automation is the use of instrument and specimen processing equipment to perform clinical assay with only minimal involvement the technologist PATELKI PATELKI Reduce human error Safety decrease laboratory costs improve turnaround time increase productivity Run more tests Test in fewer sites Operate with fewer instruments. Retain lower operating costs. Employ relatively less skilled labor. Use more automation in a paperless environment PATELKI Lab Test • Faster TOT • Accuracy, Precision, Safety Add information value • Autovalidation • Trending Effecting change using lab results • Lifestyle changes • Selection of Lab Test Autovalidation Trending Life Style Adjustments Appropriate Therapeutics therapeutics PATELKI 7 In the early years of clinical laboratory science--the 1920s, 1930s, and 1940s-tests and assays were performed manually evolution of clinical laboratory automation began in the late 1950s with the development of flame photometry and peripheral blood cell analysis PATELKI PATELKI Clin Chem 1958;4:127– 41 the Coulter Counter in 1957 revolutionized the counting of a variety of peripheral blood cells, including red blood cells and leukocytes PATELKI Wallace H Coulter Technicon Autoanalyzer II (AAII) systemPeristaltic Pump Module AutoAnalyzer is an automated analyzer using a special flow technique named "continuous flow analysis (CFA)" first made by the Technicon Corporation. The instrument was invented 1957 by Leonard Skeggs, PhD and commercialized by Jack Whitehead's Technicon Corporation. The first applications were for clinical analysis, but methods for industrial analysis soon followed. PATELKI The first multichannel analyzer to perform eight determinations simultaneously is described. The analyzer records directly on calibrated paper, providing an “immediately usable form”. One operator can perform 960 individual tests per day, equal to the output expected per person in a month with manual techniques PATELKI ClinChem 1964;10:918 –36 Multichannel analyzers allow 10 simultaneous determinations on 1 mL of serum at a rate of 60 specimens per hour PATELKI Clin Chem 1966;12:120 –36 First fully automated in clinical laboratory implement in Kochi Medical School by Masahide Sasaki (Automation Pioneer ). Modular system PATELKI Robotik / mekanik Fluidic Metode Track Sensor Komputer Software Barcode PATELKI gantry robot The SCARA (Selective Compliance Assembly Robot Arm) PATELKI Continuous Flow Analyzer • Tubing flow of reagents and patients samples Flow Injection Analyzer • Centrifuge force to mix sample and reagents Dialyzer module • Separate testing cuvets for each test and sample • Random and/or irregular access PATELKI CONTINUOUS FLOW In continuous flow analyzers, • samples were aspirated into tubing to introduce samples into a sample holder, • bring in reagent, • create a chemical reaction, • and then pump the chromagen solution into a flow-through cuvette for spectrophotometric analysis. PATELKI • The major drawbacks that contributed to the eventual demise of traditional continuous-flow analyzers in the marketplace were significant carry-over problems and wasteful use of continuously flowing reagents. PATELKI Continuous flow is also used in some spectrophotometric instruments in which the chemical reaction occurs in one reaction channel and then is rinsed out and reused for the next sample, which may be an entirely different chemical reaction. PATELKI PATELKI Discrete aliquots of specimens and reagents are pipetted into discrete chambers in a rotor The specimens are subsequently analyzed in parallel by spinning the rotor and using the resultant centrifugal force to simultaneously transfer and mix aliquots of specimens and reagents into radially located cuvets. The rotary motion is then used to move the cuvets through the optical path of an optical system PATELKI Discrete analysis is the separation of each sample and accompanying reagents in a separate container. Discrete analyzers have the capability of running multiple tests on one sample at a time or multiple samples one test at a time. They are the most popular and versatile analyzers and have almost completely replaced continuous-flow and centrifugal analyzers. PATELKI Sample reactions are kept discrete through the use of separate reaction cuvettes, cells, slides, or wells that are disposed of following chemical analysis. This keeps sample and reaction carryover to a minimum but increases the cost per test due to disposable products. PATELKI PATELKI Fluorescence Detection Technologies • Fluorescence Intensity (FLINT) • Fluorescence Polarization (FP) • Fluorescence Correlation Spectroscopy (FCS) • Fluorescence Resonance Energy Transfer (FRET) • Dissociation-enhanced lanthanide fluoroimmunoassay (DELFIA) • Homogenous Time Resolved Fluorescence (HTRF) • LANCE Ultra™ • Fluorescence Lifetime Analysis (FLA) Luminescence Detection Technologies • Glow Luminescence • Flash Luminescence • AlphaScreen™ • Electrochemiluminescence (ECL) • Bioluminescence Resonance Energy Transfer (BRET) Radiometric Detection Technologies • Filter Binding Assays • Scintillation Proximity Assays (SPA) • FlashPlates® • LEADseeker™ Absorbance Detection Technologies Other Technologies PATELKI Laboratory use • Identification of sample-containing vessels: • Identification of reagent-containing vessels: • Identification of equipment: • Identification of laboratory personnel: • Entry of instructions or data: Technology • bar codes, • Radio Frequency Identification (RFID), • biometrics, • magnetic stripes, • Optical Character Recognition (OCR), • smart cards, and voice recognition. PATELKI Reagent lot numbers are automatically linked to results Bar codes of randomly loaded samples are read Overview Tubes are sampled through pierceable caps PATELKI Pictures and video from Gen-Probe Paramagnetic microparticle capture and detection 28 Sneaker net Mobile robotics Conveyor belt Accelerated conveyor belt PATELKI 29 Mobile Robot Conveyance PATELKI 30 Ball and Socket Closure Device The Lasette (Cell Robotics, Albuquerque) PATELKI 31 Bar coding at the pointof-phlebotomy B-D id 2D vs. 1D bar codes • Reduce the number of computer interfaces • Self directing specimens RFID • Current costs of RFID around 25 cents PATELKI 32 Phlebotomy Tray Preparation BC-ROBO – mini 20 PATELKI Single tray system BC-ROBO – mini 40 Multi-tray system 33 Hematologi Kimia klinik Immunologi Analisa berbasis sel Mikrobiologi Molekular diagnostik dll PATELKI Conveyor Distribution Technologist Distribution Picture of the UVA lab here Sonic Healthcare Sydney Australia PATELKI The University of Virginia Clinical Laboratory Charlottesville, VA 35 Automated work cell A special case of an integrated system. Preconfigured, often available commercially offthe-shelf as a standard system for a given type of or class of sample processing Automated workstation capable of performing a limited set of Laboratory Unit Operations (LUO's) (as few as two) in an automated mode, coordinated by a workstation controlle PATELKI Leonard T. Skeggs PATELKI PATELKI IDS, Japan BIOPHILE,Inc., Charlottesville, VA 38 PATELKI bioMerieux’s PREVI Isola is a system for automating routine agar plate inoculation. It maximizes colony isolation, eliminates risks, and standardizes plate inoculation and results in a fully automated approach PATELKI Genomic Screen for Chronic Disease Data Interpretation Smart House Monitoring Early Warning of Disease Onset Proteomic Assessment Personal Health Improvement Health Intervention PATELKI 41 In vivo Cytometry-A Next Generation Diagnostic Tool. A Real-time health monitoring flow cytometry is a method of counting PATELKI thousands of cells per second PATELKI · AUTO1—Specimen Container/Specimen Carrier contains standards for the design and manufacture of specimen containers and carriers used for collecting and processing samples, such as blood and urine, for testing on laboratory automation systems. · AUTO2—Bar Codes for Specimen Container Identification provides specifications for linear barcodes on specimen containers for use on laboratory automation systems. · AUTO3—Communications with Automated Systems facilitates accurate and timely electronic exchange of data and information among automated instruments, laboratory automation systems, and other information systems. · AUTO4—Systems Operational Requirements, Characteristics, and Informational Elements provides standards of interest to operators for display of system status information such as specimen location, reagent supply, and warnings and alerts to support laboratory automation operations. · AUTO5—Electromechanical Interfaces provides guidance for the standardization of electromechanical interfaces between instruments and/or specimen processing and handling devices and automation systems in the automated laboratory. PATELKI Automation of the main chemistry analyzers, including immunoassay and linking them together with preanalytical and postanalytical automation to give total laboratory automation has given predictability to result availability PATELKI