Market review

Blood gas analysers

CEP09044
January 2010

Contents 2
CEP09044: January 2010
Introduction ............................................................................................. 3
Overview ................................................................................................. 4
Specifications .......................................................................................... 6
Additional features and services ........................................................... 14
Sustainable development issues ........................................................... 28
Acknowledgements ............................................................................... 32
References............................................................................................ 33
Appendix 1: Supplier contact details ..................................................... 41
Author and report information ................................................................ 43

Introduction 3
CEP09044: January 2010
CEP market reviews provide comparative product specifications for healthcare
products available to the UK market within a defined category. They supplement CEP
buyers guides, which offer more general advice on the technical, operational, and
economic considerations to be taken into account when selecting an appropriate
product. Readers are encouraged to check CEPs web site for updates.
Scope
This market review contains comparative specifications of all blood gas analysers
commercially available in the UK, including value-added features for consideration
when selecting an analyser. It should be read in conjunction with CEPs buyers
guide to blood gas analysers [1].
Inclusion of systems in the market review does not represent an endorsement.

Overview 4
CEP09044: January 2010
Analyser selection
The expanded analytical test repertoire available with the newer blood gas analysers
has resulted in an increase in their use both in critical care and in other applications.
Technological advances have seen the introduction of blood gas analysers that are
easy to use, requiring minimal maintenance and having reduced downtime.
Specifications for the 14 blood gas analysers currently available in the UK are shown
in table 1. Additional features and services provided by the manufacturers / suppliers
are shown in table 2.
The test menu available on blood gas analysers can be tailored to the users
requirements and generally includes:
blood gases - pH, pO
2
, pCO
2

haematocrit - Hct
electrolytes - sodium (Na
+
), potassium (K
+
), calcium (Ca
++
) or chloride (Cl
-
)
metabolites - glucose, lactate, urea, creatinine or neonatal total bilirubin
CO-oximetry - total haemoglobin (tHb), oxygen saturation (sO
2
),
oxyhaemoglobin (O
2
Hb), carboxyhaemoglobin (FCOHb), Met haemoglobin
(FMetHb), deoxyhaemoglobin (FHHb).
Calculated parameters
All the blood gas analysers have the option to calculate other parameters via
measured values and algorithms eg standard bicarbonate (HCO
3
), base excess (BE),
oxygen saturation (SO
2
), osmolality (OSM) etc. The number of parameters offered
varies depending on the specific analyser.
Other tests
The i-STAT system offers additional test cartridges for coagulation and cardiac
markers. The Radiometer ABL800 is also capable of measuring fetal haemoglobin
fractions (FHbF). Ionised magnesium (iMg) levels are available on the Nova
Biomedical blood gas analysers.
Reagents
With the exception of the ABL800, OPTI CCA-TS and OPTI R, no external gas
cylinders are required. All the analysers use closed, cartridge-based systems to
facilitate safe disposal of contaminated waste in sealed units. Multiple use reagent
cartridges have a set in-use life eg 28 days once inserted into the analyser. Lot-
specific information is contained in barcodes printed on the reagent packaging and
can be downloaded to the analyser using a barcode reader. Some reagents contain
radio transponders or smart chips for automatic transmission of data.
Overview 5
CEP09044: January 2010
Calibration
All analysers have calibrants traceable to the National Institute of Standards and
Technology (NIST) gases and standards.
Units of measurement
The units of measurement for each test parameter can be set at administrator level to
report results in either standardised (SI) or non-standardised units eg blood gases
can be expressed as kPa or mmHg.
Servicing
A one year warranty period is supplied with by most manufacturers with the
exception of Instrumentation Laboratory who support the GEM Premier 3500 & 4000
with five years warranty. In some cases the warranty period can be extended upon
negotiation with the supplier. Various levels of service agreement are offered by the
suppliers and faulty analysers are generally replaced by loan instruments.
Patient / operator ID
All blood gas analysers listed in table 1 require mandatory input of patient and
operator identification prior to sample measurement. This can be carried out by
manually inputting information using an alpha numeric keypad or a bar-code reader.
Connectivity
All analysers have the capability to connect either directly or indirectly, using data
management software, to laboratory or hospital information systems.
Sustainability
Manufacturer and supplier responses to a questionnaire on sustainable development
issues are presented in table 3.

Specifications 6
CEP09044: January 2010
Table 1. Blood gas analysers available in the UK

Abbott Point of Care
i-STAT 1
EliTech UK
IRMA TruPoint
IL
GEM Premier 3500
IL
GEM Premier 4000





Analytes
Blood gases (pO
2,
pCO
2,
pH)

Electrolytes (Na
+
, K
+
, Ca
++
, Cl
-
)
no Cl
-

Haematocrit

Metabolites Glucose

Lactate

Neonatal total bilirubin

BUN/Urea

Creatinine

CO-oximetry

Calculated parameters Up to 5 Up to 7 Up to 7 Up to 25
Reagent 25 single-use cartridges
individually packaged
25 or 10 single-use
cartridges individually
packaged
Multiple-use cartridges for
35 to 600 samples
Multiple-use cartridges
for 75 to 750 smples
Reagent storage
2 - 8C (6 - 9 months
shelf life) or room temp
(2 week shelf life)
Room temp except
creatinine at 2-8C
Room temperature Room temperature
Specifications 7
CEP09044: January 2010
Table 1. Blood gas analysers available in the UK (continued)

Abbott Point of Care
i-STAT 1
EliTech UK
IRMA TruPoint
IL
GEM Premier 3500
IL
GEM Premier 4000
Sample type and volume 65 95 L whole blood 125 200 L whole
blood
135 L whole blood 150 L (65 L micro
mode) whole blood
Sampling technique Injection or capillary
transfer fill
Injection Aspiration Aspiration
Self-wiping sampling probe Not applicable Not applicable

Analysis time (seconds) 130 200 60 90 85 95
Operating temperature (C) /
humidity
16 30 / 0 - 90 % non-
condensing
12 30 / 0 80% 12-32 / 15 85 % non-
condensing
Info Not supplied
Automatic calibration
& frequency
1 point With every sample Not applicable With every sample With every sample
2 point Via internal software With every sample Every 4 hours Every 4 hours
Automatic quality
control
Electronic

Liquid X on board on board
Automatic clot detection

X

On board diagnostics

Central laboratory remote control

Connectivity system Central Data Station IDMS software GEMweb GEMweb Plus
Power supply 2 x 9V Lithium or
rechargeable batteries
Mains and
rechargeable battery
Mains Mains
Dimension (cm) / weight (Kg) 23.5 x 7.2 x 7.7 / 0.650 12.7 x 29.2 x 24.1 / 2.4 44.5 x 33.0 x 30.0 / 4.2 45.5 x 30.5 x 38 / 1 20
Specifications 8
CEP09044: January 2010
Table 1. Blood gas analysers available in the UK (continued)

Inverness Medical
OPTI CCA-TS
Inverness Medical
OPTI R
Nova Biomedical
Critical Care Xpress
Nova Biomedical
pHOx Series





Analytes

Blood gases (pO
2,
pCO
2,
pH)

Electrolytes (Na
+
, K
+
, Ca
++
, Cl
-
)
plus iMg plus iMg
Haematocrit X

Metabolites Glucose

X

Lactate X X

Neonatal total bilirubin X X X X
BUN/Urea

X

X
Creatinine X X

X
CO-oximetry
Total Hb and SO
2

l

X
Calculated parameters up to 15 up to 15 up to 26 up to 10
Reagent Single-use, disposable
cassettes (packs of 25)
Multi-use cartridges in
packs of 4
Multi-use cartridges for
200 to 500 samples
Multi-use cartridges for
200 to 500 samples
Reagent storage Room temperature,
BUN at 2 8 C
Room temperature Room temperature Room temperature
Specifications 9
CEP09044: January 2010
Table 1. Blood gas analysers available in the UK (continued)

Inverness Medical
OPTI CCA-TS
Inverness Medical
OPTI R
Nova Biomedical
Critical Care Xpress
Nova Biomedical
pHOx Series
Sample type and volume 125 L whole blood,
serum or plasma
125 L whole blood,
serum or plasma
60 - 210 L whole blood,
serum or plasma
40 - 125 L whole blood,
serum or plasma
Sampling technique Aspiration Aspiration Aspiration Aspiration
Self-wiping sampling probe Not applicable X

Analysis time (seconds) 120 60 62 45 52
Operating temperature C / humidity 10 32 / 5 95% (non-
condensing)
10 32 / 5 95% (non-
condensing)
15 30 / no limit 15 30 / no limit
Automatic calibration
& frequency
1 point With each sample With each sample or at
30 minute intervals
Programmable With each sample or at
40 minute intervals
2 point Not applicable 3 hourly 2 hourly 2, 4 or 6 hourly intervals
Automatic quality
control
Electronic

X X X
Liquid
on board on board
Automatic clot detection

On board diagnostics

X X
Central laboratory remote control X X

Connectivity system Prism POC data manager Prism POC data manager
NovaNet / BioConnect NovaNet / BioConnect
Power supply Mains or integral
rechargeable battery
Mains or integral
rechargeable battery
Mains Mains
Dimension (cm) / weight (kg) 12.4 x 36.2 x 23.0 / 5.5 12.4 x 36.2 x 23.0 / 5.5 44 x 57 x 44 / 7.4 38.1 x 30.5 x 38.1 / 8.19
Specifications 10
CEP09044: January 2010
Table 1. Blood gas analysers available in the UK (continued)

Radiometer
ABL 80
Radiometer
ABL 800
Roche
Cobas b 221



Analytes
Blood gases (pO
2,
pCO
2,
pH)

Electrolytes (Na
+
, K
+
, Ca
++
, Cl
-)


Haematocrit

Metabolites Glucose

Lactate

Neonatal total bilirubin X

BUN/Urea X X

Creatinine X X

CO-oximetry

Calculated parameters Up to 32 Up to 49 Up to 39
Reagent Multi-use calibration pack
& disposable sensor
cassettes available for 50
to 300 samples.
Individual reagent
containers & disposable
gas cylinders.
Two multi-reagent packs,
separate wash and waste
bottles.
Reagent storage Room temperature Room temperature Room temperature
Specifications 11
CEP09044: January 2010
Table 1. Blood gas analysers available in the UK (continued)

Radiometer
ABL 80
Radiometer
ABL 800
Roche
Cobas b 221
Sample type and volume 70 105 L whole blood 35 195 L whole blood 40 186 L whole blood,
plasma, serum, pleural fluid
& some dialysis solutions
Sampling technique Aspiration Aspiration Aspiration or injection
Self-wiping sampling probe X

Analysis time (seconds) 100 140 145 200 66 120
Operating temperature C / humidity 12 28 / 15 32 / 15 31 /
Automatic calibration
& frequency
1 point With each test 4 hourly 1 hourly
2 point 8 hourly 8 hourly 12 hourly
Automatic quality
control
Electronic X X

Liquid
4 levels on board 3 levels on board
Automatic clot detection

On board diagnostics

Central laboratory remote control
Connectivity system Radiance Stat Radiance Stat Cobas IT 1000 (which
includes cobas IT 1000 &
cobas bgelink modules)
Power supply Mains and rechargeable
battery
Mains Mains
Dimensions (cm) / weight (Kg) 22 x 40 x 28 / 8.5 70 x 55 x 53 / 35.1 51x 59 x 60 / 45
Specifications 12
CEP09044: January 2010
Table 1. Blood gas analysers available in the UK (continued)

Siemens
RAPIDLab 1200
Siemens
RAPIDPoint 340 / 350
Siemens
RAPIDPoint 400 / 405




Analytes
Blood gases (pO
2,
pCO
2,
pH)
Electrolytes (Na
+
, K
+
, Ca
++
, Cl
-
)
Haematocrit X
Metabolites
Glucose
X

Lactate
X

Neonatal total bilirubin
X X
BUN/Urea X X X
Creatinine X X X
CO-oximetry

X X
Calculated parameters up to 24 up to 15 up to 24
Reagent Multi-use reagent
cartridges & separate
wash cartridge
Reagent module Multi-use reagent
cartridge. Separate wash
& waste cartridges.
Reagent storage 2 - 8C reagent cartridge Room temperature 2 - 8C reagent cartridge
Specifications 13
CEP09044: January 2010
Table 1. Blood gas analysers available in the UK (continued)

Siemens
RAPIDLab 1200
Siemens
RAPIDPoint 340 / 350
Siemens
RAPIDPoint 400 / 405
Sample type and volume 60 175 L whole blood,
(40 95 L micro
version)
75 120 L whole blood 100 L whole blood
Sampling technique Aspiration Aspiration Aspiration
Self-wiping sampling probe

No information supplied

Analysis time (seconds) 60 125 60
Operating temperature C / humidity 15 32 / 5- 90 % 5 30 / 5 -85% 15 32 / 5 -90%
Automatic calibration
& frequency
1 point Hourly With each sample Half hourly
2 point 8 hourly 8 hourly 2 hourly
Automatic quality
control
Electronic X X X
Liquid

X

Automatic clot detection

X

On board diagnostics

Central laboratory remote control

Connectivity system RAPIDComm Under development RAPIDComm
Power Supply Mains Mains / battery Mains
Dimension (cm) / Weight (kg) 57.8 x 52.0 x 53.3 / 29.5 32 x 37 18 / 7.3 55 x 30 x 42 / upto 18

Additional features and services 14
CEP09044: January 2010
Table 2. Additional features and value-added services
Abbott Point of Care i-STAT 1 (UK Launch 2002)
The i-STAT 1 is a hand held, portable, battery powered analyser using single-
use cartridges available in various test configurations. It is suitable for use in
point-of-care-testing in critical care, primary care, ambulatory services and
other locations where portability is required. A separate thermal printer is
available and information is printed or downloaded to a docking station using
infra-red technology.
Additional tests: ACT Kaolin, ACT Celite, PT/INR, CK-MB, cTnl, BNP.
Analytical principle: Electrochemical analysis

Analyser specific features
Suitable for neonatal use as small sample volume of 65 - 95L are required.
Calibration fluid is contained within each cassette and an automatic calibration is performed with each
test. In event of calibration failure the test will be stopped. Sample and cartridge will be wasted.
Colour coded test cartridges for easy identification.
Barometric pressure sensor determines ambient athmospheric pressure used for pO
2
sensor calibration.
QC lockout and two levels of user access.
External QC
Onboard data storage for 4000 patient and 1000 QC results.
Problems with the sample, calibration, sensors or any mechanical or electrical malfunctions of the
analyser will be indicated by Quality Check Codes with suggested corrective action where appropriate.
Training
Competency based education and training for basic and advanced operation of the system is provided as
part of the implementation process. An ongoing competency based assessment program is also available.
Installation of the data management software, Central Data Station, for networking the analysers can be
implemented if required. A training DVD is also available.
Maintenance
No analyser downtime as the instrument is immediately available for use from start up and following transfer
to a new location. No preventative maintenance required apart from general cleaning. Software update and
thermal probe check needed twice a year (15 minutes).
Service contract and warranty
Single level cover with loaned replacement for faulty analyser, subject to availability, either on site or via
courier within 24 hours. No charge if on service contract. Faulty analysers are returned to Abbott for repair.
Manufacturer supplies a one year warranty and will continue to support analyser for a minimum of seven
years after product manufacture ceases.
Additional services
Telephone and email helpline available during normal working hours. Customised assistance packages are
normally provided free of charge.
Published studies [2-29]
Additional features and services 15
CEP09044: January 2010
Table 2. Additional features and value added services (continued)
EliTech UK IRMA TruPoint (UK Launch 2004)
The IRMA TruPoint is a small, hand portable analyser with single-use cassettes
in various test configurations. It is suitable for low use point-of-care testing. It
has an integral thermal printer and on-board data management and
connectivity.
Analytical Principles: Potentiometry, amperometry, conductivity and
enzymatic.
Analyser specific features
Self-contained calibrant contained in each cassette. Blood sample is not wasted if calibration fails, as
sample is injected after the calibration has been completed.
Sample path is visible to help the user detect the presence of air bubbles, blood clots and residual
calibrant and ensure that the sample path has been correctly filled after injection.
Automatic electronic quality control. Aqueous liquid QC can be purchased from other suppliers.
QC lockout, customisable patient ID and two levels of operator ID for General and QA users.
On-board data storage for 200 patient, 150 aqueous QC, and 100 electronic QC/temperature records.
Capillary blood samples must be collected into IRMA capillary collection devices, which comprise a
capillary tube and plunger.
Arterial blood gas syringes need to be compatible with the cartridge Luer injection port.
Training
Customised operator training and materials are supplied free of charge. Competency check records are
supplied with the Implementation and Training Guide. Advanced training is available.
Maintenance
No routine or preventative maintenance is required apart from general cleaning. No analyser downtime as
the instrument is immediately available for use from start up and following transfer to a new location. The
edge connector may require replacement, at additional cost, if it becomes contaminated with blood or fails
electronic QC checks. It can be replaced by the user.
Service contract and warranty
A one year warranty with the option to extend at additional cost. A loaned replacement for a faulty analyser
is available free of charge, subject to availability. The analyser will be supported for a minimum of five years
after product manufacture ceases.
Additional services
EliTech UK Ltd. provides telephone support during normal working hours but the manufacturer, ITC (USA)
provides a 24 hour service.
Published studies [2, 20, 30-36]
Additional features and services 16
CEP09044: January 2010
Table 2. Additional features and value added services (continued)
Instrumentation Laboratory GEM Premier 3500 (UK launch 2009)
The GEM Premier 3500 has a range of self-contained multi-use cartridge PAKs
containing all the necessary components for patient testing . On board reagent
cartridge shelf-life is 2 4 weeks depending on pack size and test configuration.
A trolley is supplied for portability. It has an integral printer, barcode scanner
and has a coloured touch screen.
Analytical principles: Potentiometry, amperometry and conductivity.

Analyser specific features
Intelligent Quality Management (iQM) provides continuous, real-time quality control for automatic
detection, correction and documentation of errors.
Early warning flags indicate when a pack change is due.
Large sampling area with LED light which facilitates sampling.
Customisable tests parameters.
One level of user access.
Wireless communication to LIS/HIS using GEMweb data management software.
Training
Competency based training and certification for 3 levels of training for supervisor, key user and basic user,
training materials and IT installation tailored to individual customer needs is supplied at installation. Train
the trainer training is also an option for the promotion of cascade training. Four extra training days a year
are offered free of charge, but subsequent training days incur a charge. Training videos are available on
board the analyser.
Maintenance
The analyser requires no maintenance and has a downtime of 40 - 45 minutes following replacement of the
reagent pack. No decontamination is necessary as all reagents/waste are housed within the sealed pack. A
60 minute power interrupt function allows the analyser to be transported to a new location without power.
Service contract and warranty
The analyser is supplied with a five year warranty. In the event of a breakdown, a loaned replacement will be
provided on site within 8 working hours. Product will be supported for 10 years after the last model sold.
Additional services
Technical support helpline during office hours and manned evenings and weekends by service engineers.
Published studies [37-48]
Additional features and services 17
CEP09044: January 2010
Table 2. Additional features and value added services (continued)
Instrumentation Laboratory GEM Premier 4000 (UK launch 2008)
The GEM Premier 4000 has a range of self-contained multi-use cartridge PAKs
which contain all components for patient testing and have an on board life of 2 -
4 weeks depending on pack size and test configuration. A broad test menu is
available together with integrated CO-oximetry. A trolley is supplied for
portability. It has an integral printer, barcode scanner and has a coloured touch
screen.
Analytical principles: Potentiometry, amperometry, conductivity and
spectrophotometry.

Analyser specific features
Micro sample mode requires 65 L of capillary sample, suitable for neonatal use, however this is
insufficient for CO-oximetry
Intelligent Quality Management (iQM) system provides continuous, real-time quality control for
automatic detection, correction and documentation of errors
Early warning flags indicate when a pack change is due.
Customisable tests parameters.
Five levels of user access.
GEMweb Plus software enables remote access for real time status updates and supervisory control.
GEMweb Plus software offers on-board training and competency certification which can be
reassessed and issued annually.
Training
Competency based training and certification for 3 levels of training for supervisor, key user and basic user,
training materials and IT installation tailored to individual customer needs is supplied at installation. Train
the trainer training is also an option for the promotion of cascade training. Four extra training days a year
are offered free of charge, but subsequent training days incur a charge. Training videos are available on
board the analyser.
Maintenance
The analyser requires no maintenance and has a downtime of 30-40 minutes following replacement of the
reagent pack. No decontamination is necessary as all reagents/waste is housed within the sealed pack.
Service contract and warranty
The analyser is supplied with a five year warranty. In the event of a breakdown, a loaned replacement will
be provided on site within 8 working hours. Product will be supported for 10 years after the last model sold.
Additional services
Technical support helpline during office hours and manned evenings and weekends by service engineers.
Published studies [38, 49-56]
Additional features and services 18
CEP09044: January 2010
Table 2. Additional features and value added services (continued)
Inverness Medical OPTI CCA-TS (UK launch 2002)
The OPTI CCA-TS is a small, battery or mains powered hand portable
analyser designed for low use point-of-care testing. All the reagents are
contained in single-use cassettes, which are available in various test
configurations. A disposable gas cartridge is also required. The analyser
has an integral carry handle and printer with a colour touch screen and
infra-red port for wireless data download.
Analytical principles: Optical fluorescence and optical reflectance

Analyser specific features
Measured total haemoglobin (tHb) and oxygen saturation (sO
2
).
A sample probe contained within each single-use cassette minimises carryover or contamination.
Automatic bubble detection with visible sample path to help detect sampling errors.
Calibration fluid is contained in each cassette. The blood sample is not aspirated into the cassette
before the calibration is performed.
QC lockout and various levels of user access.
Can connect directly to LIS/HIS and has built in compact flash card for storage of last 200 results.
Training
The manufacturer will customise an installation plan tailored to individual customer requirements. On site,
comprehensive training is supplied free of charge and includes the provision of training manuals/CDs. The
provision of ongoing or competency assessment training packages is negotiable with the manufacturer.
Maintenance
The instrument is available for use after a two minute warm up period from start up or following transfer to a
new location. Minimal daily maintenance taking approx 2 minutes. Three monthly haemoglobin calibration
using tHb Calibration Cassette, which takes approximately 5 minutes. The peristaltic pump needs
replacement once a year.
Service contract and warranty
A one year warranty with the possibility to extend with a two or three year maintenance agreement upon
negotiation with the supplier at additional cost. A loaned replacement is guaranteed free of charge for a
faulty analyser during the first year or covered by a support or service contract. A service contract also
provides one engineer visit per year to check analyser, replace the peristaltic pump and arrange for any
further training required. Product supported for five years after manufacture ceases.
Additional services
A 24 hour technical support helpline is provided for all users. Peer QC comparisons are available using the
web-based portal, OPTI Medical online Quality Assurance Program (QAP).
Published studies [25, 57-63]
Additional features and services 19
CEP09044: January 2010
Table 2. Additional features and value added services (continued)
Inverness Medical OPTI R series (UK launch 2006)
The OPTI R is a small, battery and mains powered hand portable analyser
designed for low to medium volume point-of-care testing. It uses a multiple-
use sensor cassette capable of analysing up to 50 patient samples over a 7
day period. The fluid pack contains calibrant and aqueous quality controls.
A disposable gas cartridge is also required. The analyser has an integral
carry handle and printer with a colour touch screen and infra-red port for
wireless data download.
Analytical principles: Optical fluorescence and optical reflectance.

Analyser specific features
Measured tHb and sO
2
.
Automatic bubble detection and system monitoring.
Automatic QC with 3 independent levels contained in the fluid pack.
QC lockout, password protection and various levels of user access.
Can connect directly to LIS/HIS and has built in compact flash card for storage of last 200 results.
Training
The manufacturer will customise an installation plan tailored to individual customer requirements. On site,
comprehensive training is supplied free of charge and includes the provision of training manuals/CDs. The
provision of ongoing or competency assessment training packages is negotiable with the manufacturer.
Maintenance
The instrument is available for use after a two minute warm up period from start up or following transfer to a
new location. Minimal daily maintenance taking approx 2 minutes. Three monthly haemoglobin calibration
using tHb Calibration Cassette, which takes approximately 5 minutes. The peristaltic pump needs
replacement once a year.
Service contract and warranty
A one year warranty with the possibility to extend with a two or three year maintenance agreement upon
negotiation with the supplier at additional cost. A loaned replacement is guaranteed free of charge for a
faulty analyser during the first year or covered by a support or service contract. A service contract also
provides one engineer visit per year to check the analyser, replace the peristaltic pump and arrange for any
further training required by the end user. Product supported for five years after manufacture ceases.
Additional services
A 24 hour technical support helpline is provided for all users. Peer QC comparisons are available using the
web-based portal, OPTI Medical online Quality Assurance Program (QAP).
Published studies [25, 57-63]
Additional features and services 20
CEP09044: January 2010
Table 2. Additional features and value added services (continued)
Nova Biomedical Critical Care Xpress (UK launch 2004)
The CCX is a large analyser with an integral printer, which can be housed
on a trolley for portability. It offers a broad test menu of up to 20 measured
tests, including ionised magnesium, with 13 standard test menus and
includes on board CO-oximetry. Multi-use reagent packs, containing all the
necessary liquid calibrators and snap in sensor cartridges are utilised by the
analyser.
Analytical principles: Amperometry, Severinghaus, conductivity, ISE and
optical reflectance.

Analyser specific features
Measures ionised magnesium.
Measures tHb and sO
2
without full CO-oximetry.
Has a micro sampling mode, suitable for neonatal use.
On board three levels of liquid QC programmed to run at required intervals.
Maintenance using SmartCheck software.
Operator and Optional QC lockout, audible alarms and auto-paging for QC failure. Password
protection and various levels of user access.
On board data storage for 100,000 patient records.
Integrated on board data management software allows wide range of customisable instrument
operating protocols, test parameters, patient data capture, manipulation and reporting.
Training
Full on site implementation and training is provided at no cost. Ongoing training requirements provided on
site or by training CD at additional cost. Competency assessment training packages are also provided at
installation and by eLearning post installation.
Maintenance
Daily maintenance requires cleaning the sample port. Weekly & monthly maintenance takes 30-45 mins. The
analyser is maintained by a supplied UPS for a minimum of 20 minutes when moved to another location.
Service contract and warranty
One year warranty and four levels of service contract are available - Bronze, Silver, Gold or Gold Plus.
Twnty four hour technical support is available with the Gold service contract. The on site response time for
an engineer is guaranteed at 8 working hours and an instrument loan facility is available free of charge in the
event of an instrument failure. Product will be supported for 10 years after manufacture ceases.
Additional services
A 12 hour technical support helpline is provided for all users. Participation in an external quality assurance
scheme and/or a peer group quality control comparison scheme is offered at no extra cost. User group
meetings and clinical nurse educators are also available.
Published studies [64-67]
Additional features and services 21
CEP09044: January 2010
Table 2. Additional features and value added services (continued)
Nova Biomedical pHOx series models pHOx, pHOx+. pHOx+C, pHOx+L, pHOx+M (UK launch 2002)
The pHOx series is available in 5 different models and is suitable for
moderate throughput and test menu requirements,. It uses multi-use snap in
sensor cartridges and calibrator packs containing all the necessary liquid
calibrators. Reagent pack has an on board life of 30 days. An optional trolley
is available for transportation.
Analytical principles: Amperometry, Severinghaus, conductivity, ISEs &
optical reflectance.

Analyser specific features
Ionised magnesium available on the pHOx+M model.
Measured tHb and sO
2
test parameters.
Micro sampling mode available.
On board three levels of liquid QC programmed to run at required intervals.
Training
Full on site implementation and training is provided at no cost. Ongoing training requirements provided by
Nova staff on site or training CD at additional cost. Competency assessment training packages are also
provided at installation and by eLearning post installation.
Maintenance
Daily maintenance requires cleaning the sample port. Weekly & monthly maintenance takes 30-45 mins.
Service contract and warranty
One year warranty and four levels of service contract are available - Bronze, Silver, Gold, Gold Plus. Twenty
four hour technical support is available with the Gold service contract. The on site response time for an
engineer is guaranteed at 8 working hours and an instrument loan facility is available free of charge in the
event of an instrument failure. Product will be supported for 10 years after manufacture ceases.
Additional services
A 12 hour technical support helpline is provided for all users. Participation in an external quality assurance
scheme and peer group quality control comparison scheme is offered at no extra cost. User group meetings
and clinical nurse educators are also available.
Published studies - No information found.

Additional features and services 22
CEP09044: January 2010
Table 2. Additional features and value added services (continued)
Radiometer ABL80 FLEX and ABL80 FLEX CO-OX (UK launch 2006)
The ABL80 is a hand portable analyser for moderate point-of-care testing
requirements with optional CO-Oximetry. A multi-use calibration solution
pack and separate sensor cassette are available in several test
configurations and sizes. A carry handle is provided for transportation or the
analyser can be mounted onto a rolling stand or perfusion pump.
Analytical principles: Amperometry, potentiometry and conductivity.

Analyser specific features
FLEX mode adapts the measurements to the sample volume available and prioritises the test results
from a capillary sample.
Automatic sample identification using prebarcoded safePICO arterial blood gas samplers and
FLEXLINK software.
Automatic, on board QC3 quality control system uses aqueous solutions at 3 levels.
QC lockout, unlimited user IDs, seven levels of user access.
Automated entry and logging of consumables enabled using smart chips.
CO-OX module has self cleaning inlet and uses ultrasonic haemolysation and broad wavelength
spectrum to minimise risk of interference from chemical haemolysing agents.On board data storage
capacity for 500 patient, QC, calibration and system event records.
Results can be automatically sent to the LIS/HIS using a wireless network connection and a
read/write CD drive is available for data backup.
Training
An installation training package is provided free of charge allowing for 1 day of training per analyser. It can
be divided into end user, train the trainer and technical training sessions in liaison with the customer.
Training manuals, slides, information posters and e-learning modules are also provided free of charge.
Appointed trainers can provide cascade training and use the operator training checklist to assess the
competency of end users. Further training can be supplied at additional cost.
Maintenance
The analyser start up time is 8 - 10 minutes following warm up or sensor cassette replacement.
Approximately 15 minutes monthly maintenance is required.
Service contract and warranty
One year warranty. Two levels of service contract for Total or Budget service cover can be purchased
which provide one service visit and one verification visit per annum, 24 hour telephone support, 8 hour
guaranteed on-site service response and free service calls/parts with total cover and discounted for budget
cover. A free modem link can be provided by Radiometer to enable remote troubleshooting by service
personnel if required. The analyser will be supported for 5 years on cessation of production.
Additional services
24 hour technical support helpline. Participation in worldwide peer review service QA Portal.
Published studies [68-69]
Additional features and services 23
CEP09044: January 2010
Table 2. Additional features and value added services (continued)
Radiometer ABL800 series - models 805, 810, 815, 817, 820, 825, 827, 830, 835, 837 (UK launch 2004)
The ABL800 FLEX is a large bench top analyser suitable for high volume
testing in point-of-care settings. It offers a broad test menu with various test
configurations including full CO-oximetry and uses 4 individual reagent
containers, 1 waste container and 2 disposable gas cylinders.
Additional tests: Foetal haemoglobin fraction (FHbF)
Analytical principles: ISEs and optical multiwavelength analysis.
Analyser specific features
Measured tHb and sO
2
are available without full CO-oximetry.
Micro sampling mode (FLEX mode) can analyse small samples from 35L adapting the
measurements to the sample volume and prioritising test results from capillary samples.
Automatic sample identification using pre-barcoded safePICO samplers and FLEXLINK software.
Automatic sample mixing with FLEXQ module that allows queuing of 3 samples on analyser.
CO-ox analysis utilises ultrasonic haemolysation and broad wavelength spectrum to minimise risk of
interference from chemical haemolysing agents.
Customised traffic light visual and audible alarms, user-defined profiles and audio-enhanced video
tutorials, troubleshooting and help facility.
QC lockout, unlimited user IDs, seven levels of user access.
On board data storage for 2000 patient, 1500 QC, 1000 calibrations with CD-R drive for data backup.
Training
An installation training package is provided free of charge allowing for 1 day of training per analyser. It can
be divided into end user, train the trainer and technical training sessions in liaison with the customer.
Training manuals, slides, information posters and e-learning modules are also provided free of charge.
Appointed trainers can provide cascade training using the Operator Training Checklist to asses the
competency of end users. Further training can be supplied at additional cost.
Maintenance
Weekly maintenance no information supplied.
Service contract and warranty
One year warranty. Two levels of service contract for Total or Budget service cover can be purchased
which provide one service visit and one verification visit per annum free or discounted service calls and parts
depending on level of cover and 8 hour guaranteed on-site service response. A free modem link can be
provided by Radiometer to enable remote troubleshooting by service personnel if required. The analyser will
be supported for 5 years on cessation of production.
Additional services
24 hour technical support helpline. Participation in worldwide peer review service QA Portal.
Published studies [70-74]
Additional features and services 24
CEP09044: January 2010
Table 2. Additional features and value added services (continued)
Roche cobas b 221 system (UK launch 2003)
The cobas b 221 is suitable for high volume point-of-care testing. It is a
modular system with a broad test menu offering full CO-oximetry as an option
and uses two multi-reagent packs with an on-board life of 6 weeks and
separate wash and waste bottles. An optional trolley is supplied on request.
Analytical principles: ISE, conductivity and spectrophotometry.

Analyser specific features
Approved for pleural fluid pH analysis.
Parameters can be prioritised and a preferential order for testing on short samples can be set.
Automatic on-board quality control with facility to hold 120 QC ampoules (approx 2 months supply).
Reagent packs can be interchanged between analysers and have built in radio frequency transponder
to transmit information to the analyser automatically.
On board data storage for 370,000 patient, 160,000 calibration and 20,000 QC records with floppy
disc drive or USB key for data backup.
QC lockout, multiple levels of user access set by the administrator.
Training
Full training and implementation packages for the full contract period are tailored to individual requirements
and included in the purchase cost. Training options include end user training for basic principles of operation
and pre-analytical influences, link training for the delivery of cascade training and advanced technical and
maintenance training. E-learning modules are available from web-based cobas academy with a computer
based learning (CBL) tool for annual competency assessment, certification and ongoing training
requirements. Training courses are accredited with appropriate organisations for CPD points. Training
credits are provided according to the number of analysers installed and can be exchanged against additional
training courses.
Maintenance
Minimal maintenance, daily visual inspection (1 minute), weekly surface cleaning (2 minutes) and quarterly
(10 minutes). Replacement of reagent packs, sensors, printer paper and QC material require approximately
2 minutes. A supplied UPS will maintain the analyser for 10 minutes when moving to a new location.
Service contract and warranty
One year warranty with the option to extend. Comprehensive service contract covers all parts and labour
free of charge with next working day on-site response for field service engineer visit if needed. Remote
diagnostic facility is available via cobas bgelink. The analyser will be supported for 10 years following
cessation of manufacture.
Additional services
24 hour telephone technical support every day.
Published studies [75-81]
Additional features and services 25
CEP09044: January 2010
Table 2. Additional features and value added services (continued)
Siemens RAPIDLab 1200 series models 1240, 1245, 1260, 1265 (UK launch 2005)
The RAPIDLab 1200 is designed for medium to high volume testing using
multi-use cartridges with an on-board life of 30 - 32 days. It provides a
comprehensive test menu, including CO-Oximetry on a series of four
models and has a USB port for external printer connection.
Analytical principles: Potentiometry, amperometry, ISE and
spectrophotometry.

Analyser specific features
Hands free sampling using single sampling port for both capillary and syringe which has an
enclosed pathway with no exposure of sampling needle.
Low sample volume (micro sampling option) suitable for neonatal use maximises number of tests
obtained on small sample.
Automatic clot clearance with biosafe automatic sampling system.
Reagent lot number and expiry date is electronically tagged for automatic download to data
management software.
Cartridges are interchangeable across the 1200 series.
QC lockout, password protection, four levels of user access.
On board data storage for 5000 patient records, 30 days of calibration data and 3 months QC data.
Automatic Quality Control pack with sufficient reagents for 3 QCs x 3 daily, cartridge compatible
with RL 400 series.
Training
Implementation and training plan is tailored to individual customer requirements. Three levels of training
are available for Operator, Key operator and Advanced users including training materials, certificates and
eLearning packages. Built in training videos are also incorporated on board the analyser.
Maintenance
Daily maintenance involves a visual check of system status (<1 minute). Weekly maintenance takes
approx 20 minutes as the user is required to perform a deproteinise cycle (6 minutes) and condition cycle
(6 minutes) and check and replenish ready sensor fill solutions (5 minutes). The supplied UPS can
maintain the analyser for up to 30 minutes for transportation to a new location.
Service contract and warranty
One year warranty. Three levels of service contract are available for 2, 3 or 4 star cover with an on-site
service response time of 8 working hours. Remote diagnostic facility is available via RAPIDComm data
management system. The analyser will be supported for 7 years following cessation of manufacture.
Additional services
24 hour telephone technical support. Participation in National User Group and Regional User Forum
events and provision of educational materials and presentations are free of charge.
Published studies [82-86]
Additional features and services 26
CEP09044: January 2010
Table 2. Additional features and value added services (continued)
Siemens RAPIDPoint 340/ and 350 series (UK launch 2009)
The RAPIDPoint 340 and 350 are compact, hand portable blood gas
analysers designed for low use point-of-care testing. Two models are
available that offer a basic test menu for analysis of blood gases and/or
electrolytes using reagent modules.
Analytical principles: Potentiometry, amperometry, ISE and
spectrophotometry.

Analyser specific features
Automatic calibration.
On-board data storage for 64 patient records with date and time, operator and patient ID.
Training
Training supplied at installation of analyser.
Maintenance
Minimal daily cleaning required.
Service contract and warranty
One year warranty. One level service contract available, 4 star cover with an on-site service response time
of 8 working hours. Remote diagnostic facility will be available via RAPIDComm data management system
in 2010. The analyser will be supported for 7 years following cessation of manufacture.
Additional services
24 hour telephone technical support.
Published studies Newly launched system, no published studies found.

Additional features and services 27
CEP09044: January 2010
Table 2. Additional features and value added services (continued)
Siemens RAPIDPoint 400 series 400, and 405 (UK launch 2001)
The RAPIDPoint 400 and 405 are point-of-care, cartridge based blood gas
analysers with integral printer and a test menu that includes fully integrated
CO-oximetry on the 405 model. Multiple-use reagent cartridges, containing all
the components for patient testing and separate wash/waste cartridges are
used and planar sensor technology is employed to ensure the accuracy and
reliability of test results generated.
Analytical principles: Potentiometry, amperometry, conductivity, ISE,
spectrophotometry.

Analyser specific features
Hands free sampling using single sampling port for both capillary and syringe which has an enclosed
pathway with no exposure of sampling needle.
Automatic on-board quality control which monitors the entire sample pathway.
Automatic clot clearance with biosafe automatic sampling system.
Reagent lot number and expiry date is electronically tagged for automatic download to data
management software.
QC lockout, password protection and four levels of user access.
On-board data storage for 250 patient, cal and QC records.
Automatic Quality Control pack with sufficient reagents for 3 QCs x 3 daily, cartridge compatible with
RL1200 series.
Training
Implementation and training plan is tailored to individual customer requirements. Two levels of training are
available (Operator and Key Operator) including training materials, certificates and eLearning packages.
Built in training videos are also incorporated on board the analyser.
Maintenance
Minimal maintenance is required for daily visual check of system status and replenishment of consumables
as appropriate. The supplied UPS can maintain the analyser for up to 30 minutes for transportation to a new
location.
Service contract and warranty
One year warranty. Three levels of service contract are available for 2, 3 or 4 star cover with an on-site
service response time of 8 working hours. Remote diagnostic facility is available via RAPIDComm data
management system. The analyser will be supported for 7 years following cessation of manufacture.
Additional services
24 hour telephone technical support. Participation in National User Group and Regional User Forum events
and provision of educational materials and presentations are free of charge.
Published studies [77, 86-87]

Sustainable development issues 28
CEP09044: January 2010
Table 3. Sustainable development issues
Abbott Point of Care
i-STAT 1
EliTech UK
IRMA TruPoint
IL
GEM Premier 3500
IL
GEM Premier 4000
Approximate
energy use:
Operation
Standby
Negligible
Not applicable
15 Watts
Battery: 0 Watts
Standby: 1 Watts
300 watts
No standby mode
300 watts
No standby mode
Energy saving features:
Auto shut off can be
set for 1-10 or 20
minutes. LCD display
& solid state lighting
Yes No standby mode No standby mode
Audible noise
output (dBA):
Operation
Standby
Ambient levels
Not applicable
Minimal
No
Minimal Minimal
Percentage of
recyclate used
in:
Product
Consumables
Packaging
0
0
0
No information
available

50% 50%

Percentage of packaging that can
be recycled:
100 62% 50% 50%
Product lifespan: 7 years moderate use Approx. 7 years 8 years 8 years
Use of renewable resources:
No No information
available
Yes Yes
Use of RoHS regulated
substances:
Yes No Yes Yes
Sustainable development issues 29
CEP09044: January 2010
Table 3. Sustainable development issues (continued)
Inverness Medical
Opti CCA Touch
Inverness Medical
Opti R
Nova Biomedical
UK
Critical Care Xpress
Nova Biomedical
UK
pHOx Series
Approximate
energy use:
Operation
Standby
0.045 kWh
0.01 kWh
0.045 kWh
0.01 kWh
0.097 kWh 0.097 kWh
Energy saving features: Backlight and heater
off functions. LED &
fluorescent lighting
Backlight and heater
off functions. LED &
fluorescent lighting
Low power usage,
compressor only runs
during calibration etc
Low power usage,
compressor only runs
during calibration etc
Audible noise
output (dBA):
Operation
Standby
60
28
60
28
< 1dBA under normal
conditions
< 1dBA under normal
conditions
Percentage of
recyclate used
in:
Product
Consumables
Packaging
0
0
0
0
0
0
Where possible, use
recyclable materials
in instruments and
packaging
Where possible, use
recyclable materials
in instruments and
packaging
Percentage of packaging that can
be recycled:
100 100 Information not
provided
Information not
provided
Product lifespan: 5 - 10 years 5 - 10 years 8 years 8 years
Use of renewable resources:
No No Where possible, use
recyclable materials
in instruments and
packaging
Where possible, use
recyclable materials
in instruments and
packaging
Use of RoHS regulated substances: Not fully compliant Not fully compliant No No

Sustainable development issues 30
CEP09044: January 2010
Table 3. Sustainable development issues (continued)
Radiometer
ABL 80
Radiometer
ABL 800
Roche
Cobas b 221
Approximate
energy use:
Operation
Standby
0.04 KWh
0.04KWh
0.25 KWh
0.25 KWh
0.2 KWh
Not applicable
Energy saving features: LCD display LCD display Economy mode*
Audible noise
output (dBA):
Operation
Standby
58 - 68
58 - 68 (beep 75)
65
45
37 - 52
37.0 - 39.2
Percentage of
recyclate used
in:
Product
Consumables
Packaging
< 1 %
< 1 %
None
< 1 %
< 1 %
None
None
None
None
Percentage of packaging that can
be recycled:
> 95 % > 95 % 80 %
Product lifespan 7 - 10 years 7 - 10 years 5 - 7 years
Use of renewable resources: No No No
Use of RoHS regulated
substances:
Contains lead in the
soldering
Contains lead in the
soldering
Applies to some
components
Notes: > - greater than. < - less than. *reduces fluid consumption not power.

Sustainable development issues 31
CEP09044: January 2010
Table 3. Sustainable development issues (continued)
Siemens
Rapidlab 1200
Siemens
Rapidlab 340/350
Siemens
Rapidlab 400/405
Approximate
energy use:
Operation
Standby
150 kWh 150 kWh 150 kWh
Energy saving features: Standby mode Standby mode Standby mode
Audible noise
output (dBA):
Operation
Standby
< 50 dBA < 50 dBA < 50 dBA
Percentage of
recyclate used
in:
Product
Consumables
Packaging
No information
available
No information
available
No information
available
Percentage of packaging that can
be recycled:
Cardboard outer
package can be
recycled.
Cardboard outer
package can be
recycled.
Cardboard outer
package can be
recycled.
Product lifespan: 10 years 10 years 10 years
Use of renewable resources:
No information
available
No information
available
No information
available
Use of RoHS regulated substances: No information
available
No information
available
No information
available

Acknowledgements 32
CEP09044: January 2010
We should like to thank the following for their contribution to this market review.
Steph Barber, POCT Lead, Nottingham University Hospitals NHS Trust
Mark Callaghan, Deputy Head of Equipment Services, Nottingham University
Hospitals NHS Trust
Daniel Clarke, Head of Clinical Engineering, Nottingham University Hospitals NHS
Trust
Abbott Point of Care UK
Elitech UK Ltd.
Instrumentation Laboratory (UK) Ltd.
Inverness Medical UK
Nova Biomedical UK
Radiometer Ltd.
Roche Diagnostics UK
Siemens Healthcare Diagnostics (UK)

References 33
CEP09044: January 2010

1. Batki AD, Nayyar P, Thomason HL. Buyers guide: blood gas analysers. NHS
Purchasing and Supply Agency, Centre for Evidence-based Purchasing report
2010. Report CEP09043.
2. Nichols JH, Bartholomew C, Bonzagi A, et al. Evaluation of the IRMA TRUpoint
and i-STAT creatinine assays. Clinical Chimica Acta 2007; 377: 201-205.
3. Papadea C, Foster J, Grant S, et al. Evaluation of the i-STAT portable clinical
analyzer for point-of-care blood testing in the intensive care units of University
Childrens Hospital. Annals of Clinical and Laboratory Science 2002; 32: 231-
243.
4. Gault MH, Seymour ME, Howell WE. Evaluation of i-STAT creatinine assay.
Nephron 2001; 88: 178-182.
5. Pinckard JK, Zahn J, Ashby L, et al. Falsely increased i-STAT chloride results
for blood samples with increased urea. Clinical Chemistry 2001; 47(11): 2064-
2066.
6. Bailey TM, Topham TM, Wantz S, et al. Laboratory process improvement
through point of care testing. Joint Commission. Journal of Quality Improvement
1997; 23(7): 362-380.
7. Bingham D, Kendall J, Clancy M. The portable laboratory: an evaluation of the
accuracy and reproducibility of i-STAT. Annals of Clinical Biochemistry 1999;
36: 66-71.
8. Sediame S, Zerah-Lancner F, dOrtho MP, et al. Accuracy of the i-STAT
bedside blood gas analyser. European Respiratory Journal 1999; 14: 214-217.
9. Gault MH, Harding CE, Duffett S, Longerich L. i-STAT Hand-Held Point-of-Care
Analyzer for Dialysis Units. Nephron 1998; 80: 344-348.
10. Murthy JN, Hicks JM, Soldin SJ. Evaluation of i-STAT portable clinical analyzer
in a neonatal and pediatric intensive care unit. Clinical Biochemistry 1997; 30(5):
385-389.
11. Gault MH, Harding CE. Evaluation of i-STAT portable clinical analyzer in a
hemodialysis unit. Clinical Biochemistry 1996; 29(2): 117-124.
References 34
CEP09044: January 2010
12. Burritt MF, Santrach PJ, Hankins DG, et al. Evaluation of the i-STAT portable
clinical analyzer for use in a helicopter. Scandanavian Journal of Clinical
Laboratory Investigation 1996; 56(Suppl. 224): 121-128.
13. Adams DA, Buus-Frank M. Point-of-Care Technology: The i-STAT system for
bedside blood analysis. Journal of Pediatric Nursing 1995; 10(3): 194-198.
14. Mock T, Morrison D, Yatscoff R. Evaluation of the i-STAT system: A portable
chemistry analyzer for the measurement of sodium, potassium, chloride, urea,
glucose, and hematocrit. Clinical Biochemistry 1995; 28(2): 187-192.
15. Scott RS, Vlassoff D, Karon DS, et al. Evaluation of lactate methods on the
Radiometer ABL 725, i-STAT CG4+ cartridge, Nova Biomedical Lactate Plus,
Roche Integra 400 Plus, and Vitros 750 analyzers. Point of Care 2007; 6(1): 22.
(Abstract).
16. Gruszecki A, Hortin G, Lam J, et al. Utilization, reliability, and clinical impact of
point-of-care testing during critical care transport: six years of experience.
Clinical Chemistry 2003; 49 (6): 1017-1019.
17. Rossi A, Khan D, Hannan R, et al. Goal-directed medical therapy and point-of-
care testing improve outcomes after congenital heart surgery. Intensive Care
Med 2005; 31:98-104.
18. Genta VM, Ordonez L, Wyer L, et al. Acceptance plan for i-STAT cartridges. A
practical example for a lot of G3+ cartridges. Clinical Chemistry 2002; 48(6):
Supplement A188. (Abstract F48).
19. Smith MD, Davis-Street JE, Nillen JL, et al. Effects of long term storage on i-
STAT EC6+ cartridge shelf-life. Clinical Chemistry 2002; 48(6): Supplement
A193. (Abstract F67).
20. St-Louis P, Legault D. An evaluation of point of care blood gas analysers.
Clinical Chemistry 2000; 46(6): A5 Supplement. (Abstract 14).
21. Marver CL, Santrach PJ, Burritt MF. Evaluation of the i-STAT portable clinical
analyzer for the determination of blood creatinine. Clinical Chemistry 1999;
45(6): Supplement A33. (Abstract 104).
22. Dinovo EC, Lee K-D, Shin W-Y. Correlation study between four i-STAT portable
analyzers. Clinical Chemistry 1999; 45(6): Supplement A29. (Abstract 88).
References 35
CEP09044: January 2010
23. Randell EW, Varghese A. Performance of the i-STAT analyzer during transport
of neonatal patients from remote hospitals. Clinical Chemistry 1997; 43(6):
S201. (Abstract 439).
24. Murthy JN, Hicks JM, Soldin SJ. Analytical evaluation of i-STAT portable clinical
analyzer for blood gas and electrolyte analyses in pediatric samples. Clinical
Chemistry 1996; 42(6): S142. (Abstract 198).
25. Boggino HE, Bissell MG, Petersen JR, et al. Analytical evaluation of Opti 1 and
i-STAT portable analyzers for pH and blood gases: Lot to lot, precision and
correlation studies. Clinical Chemistry 1996; 42(6): S158. (Abstract 261).
26. Utz C, Gibson C, Hortin GL. Quality control for the i-STAT analyzer. Clinical
Chemistry 1995; 41(6): S157. (Abstract 548).
27. Mock T, Randall W, Yatscoff R. An evaluation of blood gas and ionized calcium
measurement on the i-STAT analyzer. Clinical Chemistry 1995; 41(6): S182.
(Abstract 654).
28. Bottjen PL, Haven MC. Evaluation of blood gas and pH methods on the i-STAT
portable clinical analyzer. Clinical Chemistry 1995; 41(6): S196. (Abstract 715).
29. Googins MK, Kraft C, Chaney K, et al. Evaluation and implementation of the i-
STAT system in the emergency department and newborn intensive care unit.
Clinical Chemistry 1995; 41(6): S187. (Abstract 677).
30. ECRI. Immediate Response Mobile Analysis (IRMA) system for Point-of-Care
(POC) blood analysis. Health Technology Assessment Information Service.
2006.
31. Ceriotti F, Del Buono L, Bonini P, et al. A two-center evaluation of the blood gas
Immediate Response Mobile Analyzer (IRMA). Clinical Chemistry and
Laboratory Medicine 2002; 40(2): 182-191.
32. Hedlund KD, Oen S, LaFauce L. Clinical experience with the Diametrics IRMA
(Immediate Response Mobile Analysis) blood analysis system. Perfusion 1997;
12: 27-30.
33. Prause G, Ratzenhofer-Komenda B, Offner A, et al. Prehospital point of care
testing of blood gases and electrolytes an evaluation of IRMA. Critical Care
1997; 1(2): 79-83.
References 36
CEP09044: January 2010
34. Wahr JA, Lau W, Tremper KK, et al. Accuracy and precision of a new, portable,
handheld blood gas analyzer, the IRMA

. Journal of Clinical Monitoring 1996;

12: 317-324.
35. Zaloga GP, Roberts PR, Black K, et al. Hand-held blood gas analyzer is
accurate in the critical care setting. Critical Care Medicine 1996; 24: 957-962.
36. James OA, Petersen JR, Bissell MG, et al. The Immediate Response Mobile
Analyzer (IRMA) for blood gases. Clinical Chemistry 1995; 41(6): S160-161.
(Abstract 562).
37. Toffaletti JG, McDonnell EH, Ramanathan LV, et al. Validation of a quality
assessment system for blood gas and electrolyte testing. Clinica Chimica Acta
2007; 382: 65-70.
38. Westgard JO, Fallon KD, Mansouri S. Validation of iQM Active Process Control
Technology. Point of Care 2003; 2(1): 1-7.
39. Mansouri S, Fallon K. Enhancing error detection in GEM Premier 3000 by
failure pattern recognition. (Abstract).AACC Critical Care and Point of Care
Testing Conference, September 11-14 2002.
40. Vukelic N, Futac DP, Topic E. Analytical properties of the GEM Premier 3000
analyzer evaluated. Biochemia Medica 2007; 17(2): 139-270.
41. Steinfelder-Visscher J, Weerwind PW, Teerenstra S, et al. Reliability of point-of-
care haematocrit, blood gas, electrolyte, lactate and glucose measurement
during cardiopulmonary bypass. Perfusion 2006; 21: 33-37.
42. Jacobs E, Ancy JJ, Smith M. Multi-site performance evaluation of pH, blood gas,
electrolyte, glucose, and lactate determinations with the GEM Premier 3000
critical care analyzer. Point of Care 2002; 1(3): 135-144.
43. Toffaletti JG, McDonnell EH, Dean LR. Evaluation of lactate in whole blood by
GEM Premier 3000. Point of Care 2002; 1(4): 229-232.
44. Ilic M, Stankovic S, Majkic-Singh N. Analytical performance of the blood gas: IL
GEM

Premier 3000. Clinical Chemistry 2005; 51: A32 Suppl. 6. (Abstract).
45. Mansouri S. Performance evaluation of the IL GEM Premier 3000 analyzer with
intelligent quality management. Clinical Chemistry 2003; 49(6): A150 Part 2
Suppl. S. (Abstract).
References 37
CEP09044: January 2010
46. Mansouri S, Fallen K, Eames P. Intelligent quality management in the GEM
Premier 3000 critical care analyzer. Clinical Chemistry 2002; 48(6): A18 Suppl.
(Abstract).
47. Ancy JJ, DOrazio P, Alexander A, et al. Performance evaluation of a new high
volume cartridge for the GEM Premier 3000 critical care analyzer. Clinical
Chemistry 2002; 48(6): A152 Supplement. (Abstract E5).
48. Sridharan R, Frayne L. GEM Premier 3000 cartridge designed for point-of-care
blood gas and electrolyte analysis: performance compared with bench-top-
analyzers. Clinical Chemistry 2000; 46(6): 211 Part 2 Suppl. S. (Abstract).
49. Beneteau-Burnat B, Pernet P, Pilon A, et al. Evaluation of the GEM

Premier
4000: a compact blood gas CO-Oximeter and electrolyte analyzer for point-of-
care and laboratory testing. Clinical Chemistry and Laboratory Medicine 2008;
46(2): 271-279.
50. Beneteau-Burnat B, Ripert S, Pernet P, et al. Blood gas point-of-care testing
with the GEM Premier 4000 in the labour and delivery room: A nine-month
experience. Point of Care 2008; 7(3): 190.
51. Cervera J, Conant J, DOrazio P. New chemistry cartridge for the GEM

Premier
4000 critical care analyzer, including electrochemical sensors for creatinine,
BUN and measured TCO
2
. Point of Care 2008; 7(3): 205. (Abstract).
52. Otero Santiago MF, Lampon Fernandez N, Vidal-Rios Vazquez P, et al.
Transferability of hemoglobin results obtained by using a POCT platform or a
haematological system. Point of Care 2008; 7(3): 157 (Abstract).
53. Pamidi PVA, Mansouri S, DeAbreu M, et al. Analytical performance of CO-
Oximetry module on GEM

Premier 4000 critical care analyzer. Point of Care

2007; 6(1): 63. (Abstract 34).
54. DeAbreu M, Pamidi P, Mansouri S, et al. Total bilirubin assay on GEM Premier
4000 critical care analyzer. Clinical Chemistry 2007; 53(6): A214 Suppl.
(Abstract E2).
55. Blanco P, Romero C, Rodriguez C, et al. Clinical evaluation of the GEM

Premier 4000 critical care analyzer. Clinical Chemistry 2007; 53(6): A177 Suppl.
(Abstract).
References 38
CEP09044: January 2010
56. Cosofret VV, DOrazio P, Shin M, et al. Incorporation of measured whole blood
bicarbonate in the GEM Premier 4000 critical care analyzer. Clinical
Chemistry 2004; 50(6): A164-165 Part 2 Suppl. (Abstract).
57. Schlebusch H, Paffenholz I, Zerback R, et al. Analytical performance of a
portable critical care blood gas analyzer. Clinical Chimica Acta 2001; 307: 107-
112.
58. Maillard D, Ferracci F, Marotte H, et al. Testing of the AVL OPTI 1 portable
blood gas analyzer during inflight conditions. Aviation, Space, and
Environmental Medicine 1999; 70(4): 346-350.
59. Boonlert W, Lolekha P, Kost GJ, et al. Comparison of the performance of point-
of-care and device analyzers to hospital laboratory instruments. Point of Care
2003; 2(3): 172-178.
60. Carayannopoulos MO, Wilhite TR, Reddy L et al. Equimolar ammonia
interference in potassium measurement on the Osmetech Opti CCA. Clinical
Chemistry 2005; 51: A50 Suppl. 6. (Abstract A156).
61. Lin C, Tusa JK. Equimolar ammonia interference in potassium measurement on
the Osmetech OPTI CCA: A reply. Clinical Chemistry 2006; 52(11): 2116-2117.
(Letter).
62. McIntire MD, Venugopal MG, Fraatz RJ, et al. Performance of new glucose and
BUN optical sensors for the Roche OPTI CCA analyzer. Clinical Chemistry
2002; 48(6): A151 Supplement. (Abstract E2).
63. Venugopal MG, McIntire M, Fraatz RJ, et al. Evaluation of glucose and BUN
optical sensors for the AVL OPTI CCA Analyzer. Clinical Chemistry 2000; 46(6):
A58 Supplement. (Abstract 218).
64. Vanavanan S, Chittamma A. Performance of a multi-profile critical care testing
analyzer. Clinical Chemistry and Laboratory Medicine 2008; 46(1): 9-14.
65. Flegar-Mestric Z, Perkov S. Comparability of point-of-care whole blood
electrolyte and substrate testing using a Stat Profile Critical Care Xpress
analyzer and standard laboratory methods. Clinical Chemistry and Laboratory
Medicine 2006; 44(7): 898-903.
66. Vanavanan S, Chittamma A. Performance of a multi-profile critical care testing
analyzer. Point of Care 2007; 6(1): 77. (Abstract 49).
References 39
CEP09044: January 2010
67. Perkov S, Flegar-Mestric Z. Comparison of arterial whole blood metabolite
determinations in Stat Profile Critical Care Xpress Analyzer with standard
laboratory methods. Clinical Chimica Acta 2005; 355:S390 Suppl. (Abstract).
68. Leader M, Cox M, Pickering D, et al. Traditional principles define automatic QC
system in cassette-based POC blood gas analyzer. Point of Care 2007; 6(1):
94. (Abstract 70).
69. Nichols JH, Karim S, Arabadjief M. Evaluation of QC
3
: The Radiometer
ABL80FLEX error mitigation system. Clinical Chemistry 2007; 53(6): A214-215
Suppl. (Abstract E4).
70. Skurup A, Kristensen T, Wennecke G. New creatinine sensor for point-of-care
testing of creatinine meets the National Kidney Disease Education Program
guidelines. Clinical Chemistry and Laboratory Medicine 2008; 46(1): 3-8.
71. Andersson A, Strandberg K, Becker C, et al. Interference testing of the
creatinine sensor in the ABL837 FLEX analyzer. Point of Care 2007; 6(2): 139-
143.
72. Ivanov A. Evaluation of the 1
st
automatic system for blood gas analysis. Point of
Care 2007; 6(1): 42. (Abstract 7).
73. Naidoo D, Day PJ, Moshides JS. Evaluation of the whole blood creatinine assay
on the Radiometer ABL837 blood gas analyzer. Clinical Chemistry 2007; 53(6):
A219 Suppl. (Abstract E17).
74. Parker C, Grenache DG. Automatic mixing by the Radiometer ABL800FLEX
blood gas analyzer is superior to manual mixing for producing a homogeneous
specimen. Clinical Chemistry 2006; 52(6): A82 Suppl. (Abstract C12).
75. Arthurs O, Dey P, Pattnayak S, et al. Point-of-care measurements on a neonatal
intensive care unit using the OMNI-S blood gas analyzer. Point of Care 2007;
6(2): 112-117.
76. Bewley B, Creed G, Goerlach-Graw A, et al. Multicenter study on the analytic
performance of a new point-of-care blood gas analyzer and its use in critical
care testing. Point of Care 2004; 3(4): 149-155.
77. Couck P, Ghys T, Van Gastel E, et al. Preliminary performance evaluation of
blood gas analyzers. Clinical Chemistry and Laboratory Medicine 2006; 44:
1030-1034.
References 40
CEP09044: January 2010
78. Rolinski B, Okorodudu AO, Kost G, et al. Evaluation of total bilirubin
determination in neonatal whole-blood samples by multiwavelength photometry
on the Roche OMNI S point-of-care analyzer. Point of Care 2005; 4(1): 3-8.
79. Grohmann K, Roser M, Rolinski B, Bilirubin measurement for neonates:
comparison of 9 frequently used methods. Pediatrics 2006; 117(4): 1174-1183.
80. Hirst D, St John A. Keeping the spotlight on quality from a distance.
Accreditation and Quality Assurance 2000; 5: 391-393.
81. Naskalski J, Solnica B, Mazur A. Evaluation of hematocrite influence on
measured concentrations of electrolytes and urea on Omni point-of-care
analyzer. Point of Care 2008; 7(3): 156. (Abstract).
82. Hotaling T, Brunelle J, Mullert K. Neonatal bilirubin method evaluation: Whole
blood on RAPIDLAB

1200 versus Plasma on VITROS

950 chemistry system.

Clinical Chemistry 2008; 54(6): A214-215 Suppl. (Abstract E69).
83. Dietzen DJ, Wilhite TR. Comparison of whole blood total bilirubin determination
in neonates on the Siemens RAPIDLAB and Radiometer ABL blood gas
analyzers. Clinical Chemistry 2008; 54(6): A235 Suppl. (Abstrat E131).
84. Hotaling T, Holman B, Nelson JE, et al. Rapidlab 1200: Optical total bilirubin
measurement of unhemolysed whole blood. Clinical Chemistry 2006; 52(6):
A194 Suppl. (Abstract E95).
85. Lynch M, Vallen-Thompson M, Canelli G. A multi-site performance evaluation of
Bayer Rapidlab 1200 analyzer. Clinical Chemistry 2006; 52(6): A82 Suppl.
(Abstract C10).
86. Oliver P, Buno A, Beltran J, et al. Point-of-care bilirubin testing in the neonatal
service at La Paz University Hospital. Point of Care 2008; 7(3): 186. (Abstract).
87. Polito FA, DeHavens A, Yeo KT. Clinical evaluation of the Chiron Rapidpoint
400 whole blood chemistry/blood gas system. Clinical Chemistry 1999; 45(6):
A132 Supplement. (Abstract 471).
Appendix 1: Supplier contact details 41
CEP09044: January 2010
UK distributor Address Manufacturer
Abbott Point of Care
Europe
Concorde House
Trinity Park
Solihull
B37 7UQ
UK
Tel: 0121 635 5080
www.abbottpointofcare.com/ISTAT
european.hr@i-stat.com
Abbott
Elitech UK Ltd Unit 6
River Park Industrial Estate
Billet Lane
Berkhamsted
Herts
HE4 1HL
Tel: 01442 869320
www.elitechuk.com
International Technidyne
Corporation (ITC)
Instrumentation
Laboratory (UK) Ltd
Kelvin Close
Birchwood Science Park
Warrington
Cheshire
WA3 7PB
Tel: 01925 810141
www.il-uk.com
Instrument Laboratory
Inverness Medical
UK
Pepper Road
Hazel Grove
Stockport
Cheshire
SK7 5BW
Tel: 0161 483 5884
www.invmeduk.com
Inverness Medical
Nova Biomedical UK C3-5 Evans Business Centre
Deeside
Flintshire
CH5 2JZ
Tel: 01244 287087
www.novabiomedical.com
Nova Biomedical Corporation
Radiometer Ltd Manor Court
Manor Royal
Crawley
West Sussex
RH10 9FY
Tel: 01293 517599
www.radiometer.co.uk
Radiometer Medical ApS
Appendix 1: Supplier contact details 42
CEP09044: January 2010
UK distributor Address Manufacturer
Roche Diagnostics
UK
Charles Avenue
Burgess Hill
West Sussex
RH15 9RY
Tel: 01444 256000
www.accu-chek.co.uk
Roche
Siemens Healthcare
Diagnostics (UK)
Newton House
Sir William Siemens Square
Frimley
Camberley
Surrey
GU16 8QD
Tel: 01276 696409
www.medical.siemens.com
Siemens

Author and report information 43
CEP09044: January 2010
Market review:
Blood gas analysers

Helen L Thomason, Armaiti D Batki,
Pamela Nayyar

Wolfson Applied Technology
Laboratory
Healthcare Development Unit
Public Health, Epidemiology and
Biostatistics,
The University of Birmingham,
Room G042
90 Vincent Drive
Edgbaston
Birmingham
B15 2SP

Tel: 0121 414 7742
Email: batkiad@bham.ac.uk

About CEP
The Centre for Evidence-based
Purchasing (CEP) is part of the Policy
and Innovation Directorate of the NHS
Purchasing and Supply Agency. We
underpin purchasing decisions by
providing objective evidence to support
the uptake of useful, safe and
innovative products and related
procedures in health and social care.
We are here to help you make
informed purchasing decisions by
gathering evidence globally to support
the use of innovative technologies,
assess value and cost effectiveness of
products, and develop nationally
agreed protocols.
Sign up to our email alert
service
All our publications since 2002 are
available in full colour to download
from our website. To sign up to our
email alert service and receive new
publications straight to your mailbox
contact:
Centre for Evidence-based Purchasing
Room 152C
Skipton House
80 London Road
SE1 6HL

Tel: 020 7972 6080
Fax: 020 7975 5795
Email: cep@pasa.nhs.uk
www.pasa.nhs.uk/cep

Crown Copyright 2010