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Water in the Clinical Laboratory

Heal Force Laboratory Division


Water in the Clinical Laboratory

Role of water in Clinical Diagnostic Purification technologies basics Delivering water to the clinical analyzers



Putting it all together

Patient Results

Water Quality

Diagnostic Instruments

Medical Technologist

Quality Control

Diagnostic instruments

Assay developmentPatient results

Troubleshooting Your analyzer

Water quality as part of the quality process

CLSI New standards

Water purification

Quality system



Normal seen Problems Frequent Calibrations High CV% Fluctuation in quality results over the day/week/month Interfered assays

Calcium Interfered by rocks, leaves, geology ALP Interfered by biofilm, detergent, rocks CK Interfered by water treatment Amylase Interfered by citrus fruit, detergents, leaves LD Interfered by effluent, leaves, H2O2 Phosphorus Interfered by citrus fruit, leaves Iron Interfered by rocks, leaves, detergents Magnesium Interfered by citrus fruit Triglycerides Interfered by plastics, chemicals Urea Interfered by citrus fruit, water treatment Troponin I Interfered by biofilm



Water for Clinical Analyzers

Cuvette washing Tubing and probe rinsing Reagent and buffer reconstitution Dilution Water Baths



Clinical AnalyzersDiagnostic

Instruments Features and benefits of automation

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 Workflow efficiency and high speed through put Instrumentation targeted to reduce operating cost with more efficient

technology Reduced operator interface



Assay Development Diagnostic Instruments

Measuring chemical changes in the body for diagnosis, therapy and prognosis

has resulted in new assay development Multiple method testing on a single analyzer Current research methodologies for infectious disease and tumor marker’s

are moving from research labs in universities to the clinical laboratory Complex methodologies are being fully automated for more routine use



Unique Challenges for Medical Technologist Medical Technologist

Verification of final clinical results to be accurate and precise are determined

by Medical Technologist Clinical decisions are not solely made on the test result, but in conjunction

with the patient’s history and symptoms Software alerts, QC reviews, calibration must all be within stated limits before

results are released 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



Reviewing Patient Results

All analytical and pre-analytical factors must be reviewed and documented

Medical Technologist must review all test results

If results are flagged, troubleshooting the cause is necessary


Patient Results

Quality ControlDiagnostic

Instruments



Troubleshooting procedures Sample handling procedures confirmed

Quality control must be reviewed Shifts and trends Peer group Previous data

Assay Reagent issue Calibrator stability

Mechanical 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.


Patient Results

Quality ControlDiagnostic

Instruments



YES

YES

YES

NO

NO

Assay

Mechanical

Decontamination

Problem solved

Problem

WHY ??

Outside Source

Water Quality

Next Steps


Diagnostic Instruments

Water Quality



Water Quality

Quality results are dependent upon reliable instrumentation and known water quality

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

Maintenance of high purity water system is essential to reliable results

Water Quality



Understanding Water Quality and MethodologyWater

Quality

Water should be considered a bulk reagent on any analyzer 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



Diagnostic Dilemma Diagnostic Instruments

Water Quality

Smaller sample size and reaction vessel are subjected to harsher environment

Inevitable build-up of biofilm in instruments, manifolds and tubing require more frequent decontaminations

butLess and less time available for maintenance of the instruments

Some sensitive assays can become contaminated with bacteria and ions 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



Biofilm Formation Diagnostic Instruments

Water Quality

Time

Surface

Particles

Organic

Bacteria

Biofilm may shed bacteria, pyrogens etc



Demonstration of ALP release from bacteria Diagnostic Instruments

Water Quality

Correlation between bacteria concentrations and levels of ALP in water



Detection methods Diagnostic Instruments

Water Quality

ALP

+

Pi

UV-Visible pNPP

Fluorescence Attophos Starbright MUP ELF

Chemiluminescence CDP-Star (dioxetane) CSPD (dioxetane) Lumigen PPD AMPPD

Substrate-Phosphate



CLSI Water Quality Standards Water Quality

Quality Control

New Standards released July 2006 (C3-A4 Vol. 26 No. 22) Nomenclature Type I,II,III has been replaced with purity types that provide

more meaningful parameters CLRW (Clinical Laboratory reagent Water) replaces Type I,II for most applications IFW (Instrument Feed Water) allows instrument manufacturers to clarify specifications for

their particular methods SRW ( Special Reagent Water) may be specified for specific applications when additional

parameter are needed to insure water quality 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



Water Contaminants

Water: H2O …. and some other things

Purification technologies

H

H

H

H

Presence of contaminants

Particles

Gases

Microorganisms

Ions

Organics



Protecting the Water Purification Unit: Pretreatment cartridge

Due to the difference in water quality around the world, additional pretreatment cartridges are required.

The cartridges provide protection and insure good performance of the reverse osmosis membrane

The pretreatment packs include 5 micron filter (1) to remove particles and activated carbon (2) to remove chlorine

12

12



What is reverse osmosis?

P P

Feed Water

PermeateReject



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



Technology Insight: Electro-Deionization

A - Anionic MembraneC - Cationic Membrane

A C A C

Cathode

Na+

Na+

H+

H+

OH-

Cl- Na+

Product

+ Cl-

Cl-

Cl-

Cl-

Reverse Osmosis Water10 - 20 mS/cm

Na+

-Anode

Reject

Na+

OH-

EDI module- Ion selective membranes- Ion exchange resins- Continuous current



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.



Ultravoilet- Application 2 Water Reservoir

Without UV Lamp With UV Lamp

Bacteria incondensation water dropletsabove water level

Biofilmdevelopmentbelow water level



Filters – Bacteria Removal

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.



Storage 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.

CLRW water should be used as it is produced Stored water is never as pure as when it is made Storage of water enhances bacterial contamination Containers need to be cleaned thoroughly between refilling. Carboys, tanks, bottles

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



A combination of advanced technologies, like Toy blocks



Reverse OsmosisRemove up to

99% of feed water contaminants

Pretreatment Cartridge

RO cartridge protection

EDI TechnologyElectrodeionization

Consistent production

of high resistivity and low TOC water

UV Lamp &Microfilter

Production of water with low

levels of Bacteria

RO systemsRO + EDI systems

Both

Type III Type II Low Bacteria Tap water

ProductWater1 2 3 4

A combination of advanced technologies



Connecting the Water Purification Unit to the Clinical Analyzer

Water is delivered in its purified state to a harsh environment within the chemistry analyzer bottle 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.



Heal Force Super ROB, Pureforce ROE



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 system as a present attached with the analyzers.

Price-sensitive, simple product design, bearable 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



Water production rate

Perf

orm

ance

ROB 50R/100R

ROB 50/100

ROE 30/70

/100

ROE 150/300

ROE 500/1000

PUREFORCE®

SUPER®

PUREFORCE®

Product Positioning

ROB-15R/30R

ROB15/30



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.



Simplified flow schematic combining purification technologies- Super ROB, Super ROB-R

15/30 L/hFor low volume single analyzers

50/100 L/hFor high volume single analyzers



Simplified flow schematic combining purification technologies- Pureforce ROE 30/70/100

30/70/100 L/hFor Multiple analyzers



Simplified flow schematic combining purification technologies- Pureforce ROE 150/300

150/300 L/hFor Multiple analyzers



Maximum compatibility

SUPER ROB, PUREFORCE ROE can be applied to prepare pure water solution for a series of biochemical analyzers



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





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





Hitachi 7100 400 40L ROB50/ROE30




Hitachi 7600-010 2400 100L ROB100/ROE100

Hitachi 7600-020 2400 100L ROB100/ROE100


Hitachi LABOSPECT008 2000 50L ROB50/ROE70

Hitachi LABOSPECT003 320 40L ROB50/ROE30






Olympus Au400 400 25L ROB50/ROE30


Olympus Au5400 3200 110L ROE150






Roche Cobas c 311 300 25L ROB50/ROE30




Roche Cobas c 411 85 1L ROB15


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





Toshiba Tba40fr 400 17L ROB30/ROE30







Mindray BS-300 300 3.5L ROB15

Mindray BS-200 200 15L ROB30/ROE30







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



Conclusions

Water is a reagent. The quality of water has an impact on the testing method.

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