MTH60-315

Advanced Techniques and Instruments in Medical Technology Laboratory

AUTOMATED CLINICAL CHEMISTRY ANALYZER

AND
FULLY AUTOMATED CLINICAL CHEMISTRY ANALYZER

D r. R u j i ko r n R atta n at h a m

Department of Medical technology

School of Allied Health Sciences
Walailak Unive rs ity
 OUTLINE

❑Principle of automated analyzers

❑ Basic types of automated analyzers

❑ Automated Clinical Chemistry Systems

❑ Quality control and maintenance

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 AUTOMATED CLINICAL CHEMISTRY ANALYZER
▪ Automated Clinical Chemistry Analyzer is an
analytical instrument with computer program and
microprocessor.
▪ Maintenance program
▪ Quality Control program
▪ Analysis program
▪ Connect with laboratory information system (LIS)
and hospital information system (HIS)

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 AUTOMATED CLINICAL CHEMISTRY ANALYZER
Advantages
 Increased number of tests/technologist
• Each technologist can perform more
tests during a period of time
 Minimizes variations in results
• Eliminate errors in pipetting,
calculations
 Small sample size and reagent volumes
Disadvantages
 Methods vary with instrument type
 Cost of equipment, maintenance,
amount of QC
 Techs must be kept knowledgeable &
careful in set-up and operations
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 AUTOMATED ANALYZERS
❑Complete laboratory automation or total laboratory ❑Semi automated system
automation (TLA) • The samples and reagents are mixed and read
• Automation system in pre-analytical, analytical, manually.
post-analytical process • Measure only few parameters
• Integrated work cells
❑Single-channel analysis: single test for all samples
❑Fully integrated automated analyzer
❑Multi-channel analysis: multiple tests per each
• Integrate work cells in analytical process sample
• Measure multiple parameters
❑Fully automated system (work cell)
• Automation in analytical system (no technologists)
• Measure multiple parameters

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 AUTOMATED ANALYZERS
Complete lab automation Fully integrate analyzer

https://www.orthoclinicaldiagnostics.com/en-us/home/vitros-automation https://diagnostics.roche.com/us/en/products/systems/cobas-pro-integrated-solutions.html

https://youtu.be/WN_VGtBAmOM

Fully automate system Semi automate

https://ordamed.com/production/lab/biohim/1466-biohimicheskiy-analizator- https://www.elitechgroup.com/italy/product/microlab-300
au680-beckman-coulter-mishima-kk-yaponiya.html
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 BASIC TYPES OF AUTOMATED ANALYZER
❑ Continuous flow analysis

• The sample flow sequentially and continuously

in tube.

• They are each sequentially mixed with reagent in

the same tube.

❑ Discrete analysis

• Each sample undergoes reaction and

measurement in a separate cuvette or chamber.

• These samples may be analyzed sequentially or in

parallel.
https://www.analyticalsolns.com.au/choosing-a-discrete-analyser.html
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 CONTINUOUS FLOW ANALYSIS
• Reagents are pumped continuously through the system.
• Sample are introduced sequentially at timed intervals and follow each other through
the same network of tubing coils, heating baths and photometer/ other detector.
• While economical for profiles of tests, not good for stats or single order tests.
• All samples get all tests, ordered or not.
• Could not easily interrupt the process once initiated.
• Also prone to “carryover”
• Wasteful of reagents
• Example: “Chem 1” By Technicon (Bayer Diagnostics)
"Chem 1" Chemistry Analyzer
http://www.mann-horton.com/HOF2.html

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 DISCRETE ANALYSIS
• Each sample is contained in a separate reaction vessel.

• Make up the majority of modern chemistry analyzers.

• Run multiple tests one sample at a time or multiple samples one test at a time called
RANDOM sampling

Example:

― Dade Behring Dimension RXL

― Kodak Ektachem

― Alfa Wasserman Ace Alera

Dimension RxL
https://www.bioprom.gr/en/product/dimension-rxl/ 9
 AUTOMATED CLINICAL CHEMISTRY SYSTEMS
Wet reagent systems
• Reagents come ready to use or lyophilized and must be reconstituted.
• System include batch and profile analyzers or stat analyzers.
Example: Beckman coullter, vitros, Roche, Hitachi, etc.

https://www.beckmancoulter.com/products/chemistry/au680 https://www.orthoclinicaldiagnostics.com/en-ca/home/vitros-4600 https://www.dialogd.com/en/equipment-en/biochemistry-

en/cobas-c-501-analyzer-en/

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 AUTOMATED CLINICAL CHEMISTRY SYSTEMS
Dry reagent systems
• Reagents can be tablets or found on cellulose fibers located on strips, cards, or
layered on film.
• Reagents easy to handle, store well, and have fairly long shelf life.
Examples: Vitros, Seralyzer, Kodak Ektachem, ChemPro, Dupont Analyst.

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 AUTOMATED CLINICAL CHEMISTRY: TERMS
➢Throughput
• Maximum samples that can be processed in 1 hour

➢ Dwell time
• Minimum amount of time required to get test result after sampling
✓Varies greatly with instrument
✓Can be important consideration when selecting instrument

➢STAT testing (short turn around time)

• Latin statum = immediate
• Test immediately; urgent requests; emergency
• Stat turn around time - within 1 hour after order entry
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 BASIC MODES OF AUTOMATED ANALYZERS
1. Batch analysis: same test for all samples
• These are convenient to analyze specimen in batches (group) such as sugar, urea or creatinine.

2. Sequential analysis: Any or multiple tests for each sample

→A→B→C→D→E
3. Parallel analysis: All samples are subjected to a series of analytical process at same time in a parallel channel (>1
channels, methods).

A B C D E
4. Random access analysis: Choose the test to be performed for each sample.

5. Single channel (test) analysis: one test for all samples (may be batch analyzer or sequential analyzer)
6. Multiple channel (test) analysis: multiple tests in each sample (may be batch analyzer or random-access analyzer
or parallel analyzer).
7. STAT analysis: sample loaded and added at any time, with option for urgent samples. Any or multiple assay run on
STAT sample. 13
 AUTOMATED ANALYZER SYSTEM

5 4
3 1
2

1. Sampling unit –aspirates sample, calibrator and control to auto-analyzer.

2. Proportioning pump and manifold –introduces (mixes) samples with reagents to effect the proper chemical reaction to
be read by the colorimeter. This pump are connected with reagent chamber at 4-8 oC.

3. Dialyzer –separates interfacing substances from the sample material by permitting selective passage of sample
components through a semipermeable membrane. 14
 AUTOMATED ANALYZER SYSTEM

5 4
3 1
2

4. Heating bath –heat fluids continuously to exact temperature (37oC). Temperature is critical for color development.

5. Colorimeter –monitors the changes in optical density of the fluid stream flowing through tubular flow cell. Color
intensities (optical density) is proportional to substance concentrations, are converted to equivalent electrical voltages.

6. Recorder –convert electrical signal from the colorimeter into a graphic display on a moving chart.
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 FOR THE AUTOMATION ROBOTIC PLATFORM AND REALIZATION PARALLEL PROCESSING..

Choi, Byung June; You, Won Suk; Shin, Seung Hoon; Moon, Hyungpil; Koo, Ja Choon; Chung, Wankyun; Choi, Hyouk Ryeol (2011). 16
QUALITY CONTROL AND MAINTENANCE

Preventive Calibration
maintenance Quality
to ensure accuracy
of test results

Controls

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 QUALITY CONTROL AND MAINTENANCE
Preventive maintenance
• Analyzer maintenance is performed according to the manufacturer’s
instructions

• Involves: Regular check of Aspiration system, Optical system and

Measurement systems

: Replacement of parts undergoing wear and tear

• Follow protocols for Daily, Weekly, Monthly and Yearly maintenance

• Maintain records

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 QUALITY CONTROL AND MAINTENANCE
Calibration
1. Calibration of machines: Done by engineers
Done for
- Measuring parts: Aspiration probes, Temperature
- Optical parts: Photodetectors & Light source
2. Calibration of analytes: Done by technicians
Done for
- All analytes at schedule intervals as decided by
Lab
- During lot change
- Post maintenance & post repair of instrument
- QC failure as part of corrective action
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 QUALITY CONTROL AND MAINTENANCE
Controls
❑ Internal quality control sample; Daily basis
• Before running patient sample
• Following preventive maintenance
• Following repair of machine
• As per QC protocol of lab

❑ External quality control sample; Monthly basis

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 PRE-ANALYTICAL PHASE
• Specimen collection
- Phlebotomists
• Specimen transport
- Right tube for right tests
- Proper patient label
- Correct draw site
- Specimen transport
- Delivery boy (Lab boy)
- Pneumatic-tube system

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 ANALYTICAL PHASE

• Sample handling
– Important to check the specimen for hemolysis, lipemia,
clots or fibrin

– Some analyzers use closed-tube, some open-tube

– Most instruments utilize a level-sensing probe to detect

the amount of serum or plasma in a tube

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 POST-ANALYTICAL PHASE
• Decreases opportunity for error
• Auto-verification
✓ Analytic modules connected to laboratory
information system (LIS) via process controller.
✓ All modules communicate with one PC.
✓ Minimize the burden on the LIS

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SUMMARY OF ANALYZER OPERATIONS
 AU480
ANALYZER

https://www.beckmancoulter.com/products/chemistry/au480

FABRIKAM 25
AU480
HARDWARES
(OUTSIDE)
1. Tank storage area (DI)
2. Reagent Syringe
3. ISE buffer syringe
4. ISE reagents
5. Sample Syringe
6. Operation button
- ON
- EM STOP
- RESET
Ion-Selective Electrode (ISE) FABRIKAM 26
AU480
HARDWARES
(INSIDE)
1. Rack feeder module

2. Sample probe
3. Cuvette wheel
4. Reagent Refrigerator
5. Reagent probe
6. Mix bar component
7. Photometer lamp
8. Wash nozzle component
9. STAT table
10. ISE module
11. Rack collection area

FABRIKAM 27
AU480 HOME MENU

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AU480 SOFTWARE

1. Menu List

2. Menus

3. Submenus

4. Screens

5. Tabs

6. Buttons for corresponding function

keys (F1 –F8 on the keyboard)

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 INTEGRATED AUTOMATED ANALYZERS

❖Continuous processing

• Clinical chemistry

• Immunology

• Hematology

❖Clinical chemistry line

❖Immunology line

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 INTEGRATED AUTOMATED ANALYZERS

Continuous processing
▪ Clinical chemistry
▪ Immunology

Core unit
cobas c 501 module cobas e 601 module
manages the transport of
photometric measuring unit, Electrochemiluminescence (ECL)
samples to each assigned
include ion-selective electrode (ISE) technology measuring unit
analytical module
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 • Bishop, M., Fody, E., & Schoeff, l. (2010). Clinical Chemistry:
Techniques, principles, Correlations. Baltimore: Wolters
Kluwer Lippincott Williams & Wilkins

• Sunheimer, R., & Graves, L. (2010). Clinical Laboratory

REFERENCES
Chemistry. Upper Saddle River: Pearson .

• MLAB 2401: Clinical Chemistry by Keri Brophy-Martinez

• MC hand out
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LAB: PRESENTATION
Group Automated clinical chemistry analyzer
1 Cobas® 8000
2 Beckman coulter DxC 700 AU
3 Vitros® XT3400
4 ARCHITECT c4000
5 DRI-CHEM NX700
6 ADVIA®1800

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 QUIZ

On Friday 9 th December 2022

6.00-7.00 PM
E-learning

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