Transcript Born for clinical analyzers

Water in the Clinical Laboratory
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Water in the Clinical Laboratory
 Role of water in Clinical Diagnostic
 Purification technologies basics
 Delivering water to the clinical analyzers
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Putting it all together
Troubleshooting Your analyzer
Diagnostic instruments
Patient results
Assay development
CLSI New standards
Water purification
Quality system
Diagnostic
Instruments
Water
Quality
Water quality as part
of the quality process
Quality Control
Medical
Technologist
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Patient
Results
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Normal seen Problems
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Frequent Calibrations
High CV%
Fluctuation in quality results over the day/week/month
Interfered assays
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Calcium
ALP
CK
Amylase
LD
Phosphorus
Iron
Magnesium
Triglycerides
Urea
Troponin I
Interfered by rocks, leaves, geology
Interfered by biofilm, detergent, rocks
Interfered by water treatment
Interfered by citrus fruit, detergents, leaves
Interfered by effluent, leaves, H2O2
Interfered by citrus fruit, leaves
Interfered by rocks, leaves, detergents
Interfered by citrus fruit
Interfered by plastics, chemicals
Interfered by citrus fruit, water treatment
Interfered by biofilm
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Water for Clinical Analyzers
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Cuvette washing
Tubing and probe rinsing
Reagent and buffer reconstitution
Dilution
Water Baths
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Clinical Analyzers
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Features and benefits of automation
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Diagnostic
Instruments
Precision optical systems for accuracy in testing
Automatic sampling and dilutions modes
Real time alerts to patient and QC failures
Improved software alerts end user to mechanical failures
Cost benefits
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Workflow efficiency and high speed through put
Instrumentation targeted to reduce operating cost with more efficient
technology
Reduced operator interface
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Assay Development
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Diagnostic
Instruments
Measuring chemical changes in the body for diagnosis, therapy and prognosis
has resulted in new assay development
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Multiple method testing on a single analyzer
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Current research methodologies for infectious disease and tumor marker’s
are moving from research labs in universities to the clinical laboratory
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Complex methodologies are being fully automated for more routine use
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Unique Challenges for Medical Technologist
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Medical
Technologist
Verification of final clinical results to be accurate and precise are determined
by Medical Technologist
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Clinical decisions are not solely made on the test result, but in conjunction
with the patient’s history and symptoms
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Software alerts, QC reviews, calibration must all be within stated limits
before results are released
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Troubleshooting instrument problems result in production delays, are costly
and non-productive activities that must be performed and documented
➙ Try to avoid diagnostic instrument service because it is expensive
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Reviewing Patient Results
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All analytical and pre-analytical factors must be reviewed and
documented
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Medical Technologist must review all test results
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If results are flagged, troubleshooting the cause is necessary
Diagnostic
Instruments
Quality Control
Medical
Technologist
Patient
Results
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Troubleshooting procedures
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Sample handling procedures confirmed
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Quality control must be reviewed
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Reagent issue
Calibrator stability
Mechanical
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Diagnostic
Instruments
Assay
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Shifts and trends
Peer group
Previous data
Quality Control
Medical
Technologist
Instrument malfunction
Error codes
If above solutions do not correct the erroneous result, further
troubleshooting must identify cause before results can be released to
physicians
➙ Delayed patient treatment.
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Patient
Results
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Next Steps
NO
Problem
Assay
Diagnostic
Instruments
YES
NO
Water
Quality
Medical
Technologist
Mechanical
YES
Decontamination
YES
Outside Source
WHY ??
Problem
solved
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Water Quality
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Water Quality
Water
Quality
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Quality results are dependent upon reliable instrumentation and known
water quality
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Analytical factors need to be controlled and optimized to reduce the number
of test failures, failed calibrations, and high blanks that can contribute to
erroneous patient results
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Maintenance of high purity water system is essential to reliable results
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Understanding Water Quality and Methodology
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Water should be considered a bulk reagent on any analyzer
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Water
Quality
The high purity water system is a separate unit, not monitored by
diagnostic software on the clinical analyzer
The unique properties of water if not processed and monitored can
produce subtle changes in assay methods
These changes in water quality can lead to erratic and inconsistent results
The quality of water required or its impact on the testing method is
often not considered until the purchase is complete
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Diagnostic Dilemma
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Smaller sample size and reaction vessel are subjected
Diagnostic
Instruments
Water
Quality
to harsher environment
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Inevitable build-up of biofilm in instruments, manifolds and tubing require
more frequent decontaminations
but
Less and less time available for maintenance of the instruments
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Some sensitive assays can become contaminated with bacteria and ions
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Bacteria release enzymes and ions whose behavior is similar to the enzymes
targeted in the assay method
➙ Increased need to monitor water quality as closely as any other
instrument malfunction
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Biofilm Formation
Diagnostic
Instruments
Water
Quality
Organic
Particles
Surface
Bacteria
Time
Biofilm may shed bacteria, pyrogens etc
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Demonstration of ALP release from bacteria
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Correlation between bacteria concentrations and levels
of ALP in water
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Diagnostic
Instruments
Water
Quality
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Detection methods
Diagnostic
Instruments
Substrate-Phosphate
Water
Quality
ALP
+
Pi
UV-Visible
 pNPP
Fluorescence
 Attophos
 Starbright
 MUP
 ELF
Chemiluminescence
 CDP-Star (dioxetane)
 CSPD (dioxetane)
 Lumigen PPD
 AMPPD
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CLSI Water Quality Standards
Quality Control
Water
Quality
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New Standards released July 2006 (C3-A4 Vol. 26 No. 22)
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Nomenclature Type I,II,III has been replaced with purity types that provide
more meaningful parameters
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CLRW (Clinical Laboratory reagent Water) replaces Type I,II for most applications
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IFW (Instrument Feed Water) allows instrument manufacturers to clarify specifications for
their particular methods
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SRW ( Special Reagent Water) may be specified for specific applications when additional
parameter are needed to insure water quality
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Autoclave and wash water will meet the requirements of previously classified Type III
Complete review of the document should be done when considering new
applications to insure the contaminants found in the source water do not
become an issue
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Water Contaminants
Water: H2O …. and some other things
Presence of contaminants
Particles
Gases
Microorganisms
Ions
Organics
Purification technologies
H
H
H
H
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Protecting the Water Purification Unit:
Pretreatment cartridge
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Due to the difference in water quality around the
world, additional pretreatment cartridges are
required.
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The cartridges provide protection and insure good
performance of the reverse osmosis membrane
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The pretreatment packs include 5 micron filter (1)
to remove particles and activated carbon (2) to
remove chlorine
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2
2
1
1
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What is reverse osmosis?
P
Feed Water
Reject
Permeate
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P
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Deionization
Diagram showing how cations and
anions are exchanged on the resin
Two bed resin is shown on the left and
mixed bed resin in on the right
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Technology Insight: Electro-Deionization
EDI module
- Ion selective membranes
- Ion exchange resins
- Continuous current
Reverse Osmosis Water
10 - 20 mS/cm
A
H+
+
Anode
Cl-
C
A
Na+
Cl-
Cl- Na+
OHNa+
-
Cathode
OH-
H+
Cl-
C
Na+
Cl-
Na+
Reject
Product
A - Anionic Membrane
C - Cationic Membrane
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Ultravoilet- Application 1 In-line
Stainless Steel Housing ,
with a UV lamp,
inside a quartz sleeve ,
easy to replace
Feed water from the bottom,
to avoid trapping air bubbles.
185 & 254 nm wavelengths.
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Ultravoilet- Application 2 Water Reservoir
Without UV Lamp
With UV Lamp
Bacteria in
condensation
water droplets
above water level
Biofilm
development
below water level
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Filters – Bacteria Removal
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Screen 0.2 µm filters
Designed for the removal of particles and microorganisms from liquids
and gases.
Use of PVDF membranes, provide high flow rates and throughputs,
low extractables, broad chemical compatibility and the lowest protein
binding of any membrane available.
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Storage
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CLRW water with a resistivity >10 megohm-cm cannot be stored
because ionic and organic contamination will leach from the
atmosphere and container materials in which it is stored.
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CLRW water should be used as it is produced
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Stored water is never as pure as when it is made
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Storage of water enhances bacterial contamination
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Containers need to be cleaned thoroughly between refilling.
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Carboys, tanks, bottles
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Notorious source of contamination since we often refill them without
thoroughly cleaning them when they are emptied
Some plastic materials out-gas polymers and plasticizers, and these end
up in the water
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A combination of advanced technologies, like Toy blocks
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A combination of advanced technologies
RO systems
RO + EDI systems
Pretreatment
Cartridge
RO cartridge
protection
1
Tap water
Reverse Osmosis
Remove up to
99% of feed water
contaminants
2
Type III
Both
EDI Technology
Electrodeionization
Consistent
production
of high resistivity
and low TOC water
UV Lamp
&Microfilter
Production of
water with low
levels of Bacteria
3
4
Type II
Low Bacteria
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Product
Water
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Connecting the Water Purification Unit to the
Clinical Analyzer
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Water is delivered in its purified state to a harsh environment within
the chemistry analyzer bottle
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Water bottles inside analyzer are not frequently decontaminated
Electronics, mechanical hardware, pumps all create heat within the
analyzer cabinet, thus raising the interior temperature of the water bottle.
Increased temperatures enhance the growth of bacteria and biofilm
within the instruments manifolds and tubings.
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Super ROB, Pureforce ROE
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Business Analysis for water purification systems
Context
What do dealers/buyers
think
What kind of product do
dealers/buyers want
When dealers initially
sell clinical analyzers
to laboratory
Consider water purification Price-sensitive, simple
system as a present
product design, bearable
attached with the analyzers. service time
When end user starts
to purchase systems
by themselves
Tailored designed for the
lab, solve users’ current
problem
High quality product with
needed features, easy to
use, long service time
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Performance
Product Positioning
ROB-15R/30R
ROB15/30
ROB 50R/100R
ROE 30
/70
/100
ROE
150/300
ROE
500/1000
ROB 50/100
Water production rate
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Water Purification Systems
Our product range delivers consistent water quality feeding a single clinical analyzer,
large automated analyzers and multiple analyzers on a distribution loop.
To help you choose the most suitable system for your clinical analyzer requirement,
we have developed the reference table blow.
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Simplified flow schematic combining purification
technologies- Super ROB, Super ROB-R
15/30 L/h
For low volume single analyzers
50/100 L/h
For high volume single analyzers
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Simplified flow schematic combining purification
technologies- Pureforce ROE 30/70/100
30/70/100 L/h
For Multiple analyzers
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Simplified flow schematic combining purification
technologies- Pureforce ROE 150/300
150/300 L/h
For Multiple analyzers
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Maximum compatibility
SUPER ROB, PUREFORCE ROE can be applied to prepare pure water solution for a
series of biochemical analyzers
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Maximum compatibility
Brand
Model
Test
Water Usage Heal Force Solution
Abbott
C16000
1600
54L
ROB100/ROE100
Abbott
C8000
800
25L
ROB50/ROE70
Abbott
C4000
400
TBD
RO30/ROE30
Abbott
Ci 16200
1600
54L
ROB100/ROE100
Abbott
Ci 8200
800
25L
ROB50/ROE70
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Maximum compatibility
Brand
Model
Test
Water Usage Heal Force Solution
Beckman
5811
2000
63.5L
ROB100/ROE100
Beckman
5821
4000
125.5L
ROE150
Beckman
5831
6000
187.5L
ROE300
Beckman
5841
8000
249.5L
ROE300
Beckman
AU680
800
30L
ROB50/ROE70
Beckman
AU480
400
20L
ROB30/ROE30
Beckman
UniCel
D×C800
1400
16L
ROB30/ROE30
Beckman
UniCel
D×C600
990
16L
ROB30/ROE30
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Maximum compatibility
Brand
Model
Test
Water Usage Heal Force Solution
Hitachi
7100
400
40L
ROB50/ROE30
Hitachi
7070
360
25L
ROB30/ROE30
Hitachi
7170
800
40L
ROB50/ROE30
Hitachi
7180
800
40L
ROB50/ROE30
Hitachi
7600-010
2400
100L
ROB100/ROE100
Hitachi
7600-020
2400
100L
ROB100/ROE100
Hitachi
7020
200
40L
ROB50/ROE30
Hitachi
LABOSPECT008
2000
50L
ROB50/ROE70
Hitachi
LABOSPECT003
320
40L
ROB50/ROE30
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Maximum compatibility
Brand
Model
Test
Water Usage Heal Force Solution
Olympus
Au400
400
25L
ROB50/ROE30
Olympus
Au640
800
40L
ROB50/ROE70
Olympus
Au5400
3200
110L
ROE150
Olympus
Au2700
1600
62L
ROB100/ROE100
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Maximum compatibility
Brand
Model
Test
Water Usage Heal Force Solution
Roche
Cobas c 311
300
25L
ROB50/ROE30
Roche
Cobas c 501
1000
40L
ROB50/ROE70
Roche
Cobas c 502
600
40L
ROB100/ROE70
Roche
Cobas c 701
2000
40L
ROB100/ROE70
Roche
Cobas c 411
85
1L
ROB15
Roche
Cobas c 601
170
30L
ROB50/ROE70
Roche
Cobas c 602
30L
ROB50/ROE70
Roche
Module D2400
50L
ROB100/ROE70
Roche
Module P800
50L
ROB100/ROE70
Roche
Module E170
30L
ROB50/ROE70
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Maximum compatibility
Brand
Model
Test
Water Usage Heal Force Solution
Toshiba
Tba40fr
400
17L
ROB30/ROE30
Toshiba
Tba120fr
800
25L
ROB50/ROE30
Toshiba
Tba2000fr
1600
64L
ROB100/ROE100
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Maximum compatibility
Brand
Model
Test
Water Usage Heal Force Solution
Mindray
BS-300
300
3.5L
ROB15
Mindray
BS-200
200
15L
ROB30/ROE30
Mindray
BS-400
400
64L
ROB50/ROE70
Mindray
BS-800
800
38L
ROB50/ROE70
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Maximum compatibility
Brand
Model
Test
Water Usage Heal Force Solution
Siemens
Dimension RXL
750
3.2~5.0L
ROB15
Siemens
Dimension Xpand
400
2L
ROB15
Siemens
ADVIA 2400
2400
40L
ROB100/ROE70
Siemens
ADVIA 1800
1800
30L
ROB50/ROE70
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Conclusions
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Water is a reagent.
The quality of water has an impact on the testing method.
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