Buyers Guide Urine Monitors For Diabetes

Buyers guide
Point of care devices for the

measurement of HbA1c and low
concentration albumin in urine
CEP08057
June 2009
Contents
Introduction ............................................................................................. 3
Technical considerations ......................................................................... 6
Operational considerations.................................................................... 10
Economic considerations ...................................................................... 16
Purchasing ............................................................................................ 20
Market review........................................................................................ 24
Acknowledgements ............................................................................... 62
Glossary ................................................................................................ 63
References............................................................................................ 64
Appendix 1: Supplier contact details ..................................................... 69
Appendix 2: EU procurement procedure ............................................... 72
Appendix 3: Technical evaluation data .................................................. 74
Author and report information.................................................................86
CEP08057: June 2009
Introduction
Devices that provide analyses at the point of care are now commonplace. Obtaining
prompt results can increase clinical effectiveness and can contribute to improved
outcomes for patients, but results must be accurate and reliable. The improved
reliability and range of point of care testing (POCT) devices has led to their increased
use in community clinics, general practitioner (GP) surgeries and the home
environment. There is a growing demand for POCT as patients exercise choice and
have a greater range of healthcare facilities available to them [1]. Clinical
effectiveness of POCT needs further evaluation with respect to patient outcomes [2].
In the 2006 report on the NHS Pathology Services in England, chaired by Lord Carter
of Coles [1], it is stated that these developments in near-patient testing must be safe,
accurate and foolproof. POCT services must be well supported by a robust
management structure, and accreditation, audit and clinical governance should be
integrated with that of the laboratory [3]. Information technology (IT) links with local
laboratories play an important part in facilitating appropriate transfer and storage of
POCT results, which currently are not always added to the patients notes.
The 2006 report recognised that by locating test equipment near to the patient, test
results can be made available more rapidly, and decisions on appropriate treatment
taken with minimal delay. This could be especially valuable when:
a patients life is under threat

managing a long term condition where results can inform the consultation
between patient and carer
the patient has heightened concern about the outcomes of the test
more efficient triage of patients is needed.
POCT can increase the costs of testing, but has the potential to generate savings
elsewhere in the patient pathway, through earlier treatment, reduction in the number
of clinic visits required, shortened in-patient stays etc [1].
Scope
This buyers guide describes POCT devices for haemoglobin A1c (HbA1c) and low
concentration albumin in urine that are currently available in the UK. Comparative
information is presented for quantitative measurement of HbA1c and quantitative,
semi-quantitative and qualitative measurement of low concentration albumin in urine
(tables 1-3). The tables include the results of a short sustainable development survey
(tables 11 and 12) an ergonomic assessment (tables 5 and 6), a survey of current
users (tables 5-8) and a limited technical evaluation (tables 24-32 and figures 5-11).
Technical, operational and economic considerations and information on purchasing
are also presented.
CEP08057: June 2009
Introduction
Background
The incidence of both type 1 and type 2 diabetes is rising in the UK [4]. It has been
shown in the Diabetes Control and Complications Trial (DCCT) and the UK
Prospective Diabetes Study (UKDPS) that good control of blood sugar
concentrations in both types of diabetes reduces the risk of microvascular disease
such as renal failure and reduces the long term risk of macrovascular disease such
as coronary heart disease [5-7]. HbA1c concentration is an indicator of the level of
blood glucose control over the past 3 months, weighted towards the control of the
last 30 days. HbA1c measurements therefore provide a good means of monitoring
diabetic glycaemic control and response to treatment. It is widely accepted that the
risks of developing micro- or macrovascular disease are minimised by maintaining
HbA1c concentrations as low as possible without increasing hypoglycaemic episodes.
Patients with diabetes and those suffering from hypertension are at risk of developing
renal disease. Early detection of renal disease permits prompt treatment and better
patient outcomes [7, 8]. Urine albumin measurements can be used to screen for the
presence of elevated urine albumin concentrations (albuminuria) and to monitor the
progression of kidney disease and response to treatment.
This guide covers products for point of care measurement of HbA1c and low
concentration albumin in urine on the UK market in June 2008. The products are
described in detail in the market review (page 23).
This guide includes four urine albumin analysers, three of which use single-use
disposable cartridges or cuvettes, and five non-quantitative albumin urine reagent
strips. Two of the analysers also measure creatinine allowing the calculation of the
albumin:creatinine ratio (ACR) as recommended in NICE guidance [9]. Three of the
urine reagent strips measure creatinine as well as albumin. One strip is used with an
electronic reader which removes subjective visual reading and provides accurately
timed reading and recording of results. Three of the analysers offer HbA1c and urine
albumin measurement. In addition the guide includes two analysers which only
measure HbA1c.
National guidance
National service frameworks
The National Service Framework for Diabetes [10] recommends that all laboratories
measuring HbA1c should participate in an external quality assessment (EQA) scheme
for HbA1c and should use a method of proven accuracy and reproducibility. POCT
analysers should also be subject to EQA.
The National Service Framework for Renal Services [11] indicates that diabetes and
hypertension are the greatest risk factors for the development of chronic kidney
CEP08057: June 2009
Introduction
disease (CKD). Early stage CKD can be detected by testing urine for low
concentration albumin in at risk populations. Early detection will permit timely
intervention before dialysis or transplantation become necessary.
NICE
Guidance from the National Institute for Health and Clinical Excellence (NICE) states
that, provided there is no disabling hypoglycaemia, the target HbA1c concentration for
children, young people and adults with type 1 diabetes is 7.5% HbA1c [12]. For adults
with increased risk of developing complications of diabetes the target is 6.5% HbA1c.
HbA1c should be measured by a DCCT harmonized method 2-4 times a year as
required. If the HbA1c concentration is consistently >9.5% additional support should
be offered.
Lowering HbA1c levels in type 2 diabetes reduces tissue damage [13]. Patients with
type 2 diabetes should be encouraged to keep HbA1c concentration to 6.5% or below
if it is safe and appropriate for that individual, to improve their longer term quality of
life. Individual targets may be set above this following agreement with the individuals
health care team.
It is inappropriate to monitor glycaemic control by measurement of HbA1c in the
presence of haemoglobinopathies or increased red blood cell turnover [9, 12].
Microalbuminuria should be monitored annually to screen for signs of complications
of type 1 diabetes from the age of 12 [12]. NICE defines microalbuminuria in patients
with diabetes as urine albumin concentration greater than or equal to 20 mg/L or an
ACR greater than or equal to 2.5 mg/mmol (men) or 3.5 mg/mmol (women), and
recommends that urinary ACR concentration is measured annually in patients with
type 2 diabetes [9]. Microalbuminuria can predict total and cardiovascular mortality.
Measurement of ACR is recommended for patients with chronic kidney disease
(CKD) in preference to other tests of proteinuria, including urine reagent strips,
unless they specifically measure albumin at low concentrations [14]. A summary of
the NICE guidance [15] highlights that reagent strips for detecting albumin in urine
are not quantitative. Quantitative ACR measurement is more sensitive for early
detection of CKD than the protein:creatinine ratio (PCR). Those patients without
diabetes should be referred for specialist assessment when the ACR is >
30mg/mmol.
The Department of Health has produced leaflets for GPs and laboratories highlighting
the advice on the detection and quantitation of proteinuria given in the NICE
guidance on chronic kidney disease [16, 17, 14].
CEP08057: June 2009
Technical considerations
POCT devices are likely to be used by staff with little clinical laboratory experience.
They must therefore be robust, simple to use, and designed to prevent reporting of
erroneous results. POCT results should ideally match those produced by the
laboratory so that a patients progress can be consistently monitored whichever
testing method is employed.
Technical guidelines
Calibration of laboratory and POCT methods to the same standard material ensures
comparability of results, facilitating interpretation. Analysers are usually calibrated by
the manufacturers using a secondary reference material which has itself been
calibrated against a primary reference material.
HbA1c
All POCT and laboratory methods should be certified by the National
Glycohemoglobin Standardization Program (NGSP) and traceable to DCCT. Interassay imprecision should be < 5%, preferably < 3%, and laboratories should be
aware of potential interference by haemoglobin variants [18]. Method calibration
should be traceable to the International Federation for Clinical Chemistry (IFCC)
reference measurement system for HbA1c [18,19].
NGSP certification [20] requires specific bias criteria with respect to an NGSP
secondary reference laboratory method:
level 1 certification 95% confidence intervals (CI) of differences must be

within 0.75% HbA1c
level 2 certification 95% confidence intervals (CI) of differences must be
within 0.85% HbA1c.
Albumin
The analytical coefficient of variation (CV) of methods for the detection of
microalbuminuria should be <15%. Semi-quantitative or qualitative screening tests
should be positive in > 95% of patients with microalbuminuria. Positive results must
be confirmed by an accredited laboratory [18].
Devices for the measurement of HbA1c

Sample
True point of care measurements require freshly collected samples which require no
further processing. For these devices, whole blood capillary samples give optimum
performance, although some can also use venous blood samples. Heparin,
ethylenediaminetetraacetic acid (EDTA) or fluoride oxalate are acceptable
anticoagulants for most HbA1c measurement devices.
CEP08057: June 2009
Calibration and reportable ranges

The IFCC has established an international reference measurement system for HbA1c
which should be used for calibrating all HbA1c methods. In the UK it is recommended
that HbA1c results should be reported in both IFCC units (mmol/mol) and derived
NGSP units (%), synonymous with DCCT, from June 2009 onwards. Conversion
between the IFCC and NGSP units is achieved by the IFCC-NGSP master equation
[19]. The reportable ranges of POCT devices must be suitable for monitoring
glycaemic control in patients with diabetes and should extend from at least 4-14%
HbA1c.
Analytical errors and interference
POCT results must be reliable as operators may not be aware of potential sources of
error. Analysers should give error messages when an error in the analytical
procedure has occurred, (whether due to the analyser or the operator), and should
not provide a numerical result in such circumstances.
However, the presence of interfering substances in the sample may produce
erroneous results. Haemoglobin (Hb) variants, including fetal haemoglobin (HbF), are
the most significant source of interference and they can be present in glycated and
non-glycated forms. Their presence is detectable by high performance liquid
chromatography (HPLC) methods but not by current POCT methods. Therefore all
patients to be monitored using a POCT device should have an initial sample
measured by an HPLC method to check for the presence of haemoglobin variants.
Analysers using methodology based on boronate affinity chromatography are not
susceptible to interference by variant haemoglobins but those based on
immunological techniques will have variable susceptibility depending on the specific
antibody used [21]. The prevalence of haemoglobin variants is raised in some ethnic
groups. The antenatal and newborn screening programmes for sickle cell disease
and thalassaemias have raised awareness of the prevalence of haemoglobin variants
[22].
HbA1c concentrations are disproportionately low in patients with increased red blood
cell turnover or anaemia, and should not be used to monitor glycaemic control in
such patients.
Devices for the measurement of urine albumin and ACR

Sample
A timed urine collection without added preservative is the recommended sample type
for urine albumin or ACR measurement. Screening using an untimed sample
(preferably early morning) is acceptable if an appropriate cutoff concentration is used
for increased albumin excretion. The measurement of creatinine in addition to
CEP08057: June 2009
albumin improves the reliability of results from untimed urine collections [11, 18]. If
the sample cannot be measured shortly after collection it should be refrigerated for
no more than a week, but should not be frozen. A transparent container is required to
aid dipping of the urine reagent strips.
Calibration and reportable ranges
The majority of the urine albumin POCT measurement devices are calibrated to the
Certified Reference Material (CRM) 470 (also named ERM-DA470) from the
Reference Preparation for Proteins in Human Serum (RPPHS). The quantitative
creatinine methods are calibrated to Standard Reference Material (SRM) 914a from
the National Institute of Standards and Technology (NIST). The reportable ranges of
POCT devices for albumin and creatinine should be suitable for screening purposes
given the usual cutoff concentration for a normal urine albumin of 20 mg/L and a
normal ACR of 2.5 or 3.5 mg/mmol for patients with diabetes and 30 mg/mmol for
clinically significant proteinuria for those patients without diabetes [23, 12, 16].
Quantitative urine albumin measurements must be used for monitoring disease
progression and response to treatment.
Analytical methodology
Immunologically based tests for urine albumin are more specific than those involving
a chemically based colour change. Some methods for creatinine measurement
involve use of an enzyme and a chemically based colour change and others only
involve a chemically based colour change. Analysers which measure urine creatinine
provide the ACR results alongside results for albumin and creatinine.
Analytical errors and interference
Analysers measuring albumin, quantitatively or semi-quantitatively, should give error
messages when an error in the analytical procedure has occurred (whether due to
the analyser or the operator), and should not provide a result in such circumstances.
One possible interferent is haemoglobin. It is also important to check whether the
device is adversely affected by very high levels of albumin giving rise to erroneously
low results.
Sources of error in POCT

A variety of errors can occur throughout a POCT procedure in addition to those
occurring during the measurement. Pre-analytical errors for POCT include incorrect
reagent or consumable storage and preparation for use, incorrect sample collection
and patient identification. Post-analytical errors include mis-recording of the result.
CEP08057: June 2009
Quality control and quality assurance

At least two quality control (QC) materials with different values should be analysed as
an independent measure of assay performance [18]. Material suitable for internal QC
of this type of device is generally supplied or recommended by device suppliers.
Some devices store QC results but none currently have data management systems
which would allow the production of Levey Jennings plots to monitor long-term
analyser performance and therefore rely on downloading results to a computer to
produce these plots.
Participation in external quality assessment schemes (EQAS) enables the user to
monitor both the performance of the device and the operator. It is important that all
these POCT devices used for clinical analysis should participate in an accredited
EQAS [10] and several national schemes are available.
CEP08057: June 2009
Operational considerations
10
POC testing by non-laboratory healthcare professionals requires well organised

support from laboratory staff to ensure the provision of accurate and reliable results.
The organisational structure needed for this has been detailed by the CLSI, the
Medicines and Healthcare products Regulatory Agency (MHRA) and in International
Standard ISO 22870 [24-27].
Space requirements, accessories, consumables, storage and

disposal
POCT analysers ideally should have a small footprint. Where a separate printer is
supplied more space is needed and a second power point might be required. Care
must be taken to place analysers so that all operators can see the screen easily in
ambient lighting, avoiding glare.
Space for consumable storage needs to be considered. Most consumables for these
analysers require long-term storage at 2-8C; some can be used directly from the
fridge. Refrigerated space may be difficult to provide at POC. Some consumables
can be kept at room temperature for 1-3 months and therefore room temperature
storage space will be required. Good stock control measures need to be adopted.
Infection control procedures should be adopted and the analyser placed in a suitable
location to avoid contamination of other products.
Portability can be convenient for POCT devices and purpose-made carrying cases to
hold the analyser and consumables can be very useful.
Battery operation can allow greater flexibility of location for use, however the most
common use would be in a hospital or GP surgery diabetic clinic where, in the UK,
mains electricity is readily available.
Some analysers have on-board printers and others may have separate printers
available to use with them. The ability to print onto labels is an asset when securing
results into a patients notes. Printouts from thermal printers are subject to fading
making them unsuitable for storage. Photocopies of thermal printouts are acceptable
but this may not be convenient at the POC. Use of an inkjet printer would overcome
the problem of printout fading.
As IT links across the NHS improve, the goal of recording and transferring all results
to an electronic patient record comes closer. The use of bar code readers to enter
patient details into the analyser is becoming more important and reduces the risk of
transcription errors at this point. The ability to record patient and operator IDs is also
important to reduce reporting errors due to misidentification of results. Electronic
storage and transfer of results are only of use if the patient ID is part of the stored
CEP08057: June 2009
11
result. The record of patient and operator IDs is also important to the point of care coordinator who requires them to be able to check an operators frequency of use and
error record to determine any need for retraining. Some point of care analysers offer
the possibility of locking out poorly performing operators. Production of a full audit
trail requires access to the record of patient and operator ID. Complete audits of
quality control values can also be recorded if QC results are stored separately from
patient results.
A touchscreen or a keypad can be used to enter information into POCT analysers. It
is essential that any touchscreen or keypad is designed to be easy to clean.
Consumables for the quantitative analysers vary from self-contained cartridges or
cuvettes to multiple individual components. The non-quantitative devices are all urine
reagent strips of varying design. Cartridges and cuvettes are packaged individually
and the packet should not be opened until a measurement is to be made. Urine
reagent strips are supplied in pots usually containing 25-100 strips. It is essential to
replace the lid on the pot as soon as a strip has been removed, to prevent
deterioration of the remaining strips.
The safe disposal of the used consumables from POCT must be considered. These
should not contain hazardous chemicals requiring special treatment but will all
contain patient sample and therefore have to be disposed of as biohazardous waste.
Most areas where POCT is performed will already have suitable systems for the
disposal of biohazardous waste.
Service provision, workflow and impact on patient pathways

POCT devices are designed for relatively low sample throughput. More than one
analyser may be needed by busy clinics. In a well run clinic, the patient can have the
HbA1c and urine albumin or ACR measurements performed alongside weight and
blood pressure checks before seeing the clinician. With all results available, the
doctor can discuss them with the patient and when necessary alter the treatment
without the need for a second visit. There is good evidence that the use of POC
measurement of HbA1c in both primary and secondary care settings leads to an
improved clinical outcome for the patient when compared to measurement in a
laboratory [6, 7, 28].
There is no evidence to show that POC measurement of urine albumin
concentrations results in improved clinical outcome for the patient but there is clear
evidence linking raised urine albumin excretion with early diabetic nephropathy [28].
POC urine reagent strip testing for albumin could not be recommended for assessing
non-diabetic nephropathy with respect to improved clinical outcomes [29].
CEP08057: June 2009
12
It is the combined use of the test and treatment that yields an improved health
outcome in diabetes [28].
Staff requirements, training and instructions

Most POCT device manufacturers recommend that their devices are used by
healthcare professionals; generally all staff grades are suitable provided training and
competency are documented. Staff chosen to perform POCT must be skilled in
obtaining good patient samples and in the case of the visual reading of urine reagent
strips must have good colour vision.
Training is essential even though some suppliers do not offer it. Sufficient training
sessions must be offered to allow for multiple users of the devices, staff turnover and
refresher training. Sessions may take between 30 minutes and 2 hours depending on
the complexity of the device. Regular competency checks must form part of the
training scheme. Only staff recorded as trained and competent should be allowed to
carry out POCT. Many hospitals use cascade training; supplier-trained hospital staff
can train other hospital staff, often a role for laboratory trained POC support team
staff. Some manufacturers produce electronic or online information to assist with
training and competency checks.
Instruction for use (IFU) and operator manuals supplied with all devices should meet
the requirements of the In Vitro Diagnostic Medical Device Directive (IVDD).
Ergonomic assessment
POCT analysers vary in the amount of operator time and input required to achieve a
result; those using a self-contained cartridge or cuvette require the least. Participants
in an ergonomic assessment concluded that the most important attributes of these
analysers should be, in order of importance:
accuracy of results
ease of use
availability of an audit trail including identities and lot numbers
time taken for the test
lack of any subjective aspect in carrying out the test and reading the result
simple screen instructions using words and symbols
room temperature storage of consumables.
Devices should be sufficiently robust and foolproof to work reliably even when the
operator is under pressure e.g. in accident and emergency departments.
CEP08057: June 2009
13
Urine reagent strip good features:
an automated reader is required to remove all subjective elements of reading

the correct concentrations
sufficient time between reading different analyte results improves accuracy
for visually read strips.
strips should fit into the widely available universal sample container.
Poor design features for analysers and urine reagent strips are:
numerous operator dependent steps

awkward or unfamiliar procedures e.g. pipetting
wiping the sample collection device with potential for sample loss by wicking
noisy
accessories which might go missing
small display screen and font
excess information obscuring clear display of the result on screen or printout
slow running test results operator distracted by alternative task
manual result recording, open to transcription errors
manual timing of urine reagent strips reading
result dependence on subjective colour matching
risk of overturning sample container when urine dip-stick needs to be dipped
for several minutes.
Servicing and maintenance

Some suppliers offer a service contract or an extended warranty to support their
analysers. Most suppliers offer an exchange service for a faulty analyser so that the
clinical site has a functioning analyser while the faulty one is being repaired.
The ideal POCT device should have minimal maintenance and remain reliable. The
maintenance must be manageable by non-laboratory staff although laboratory staff
may need to replace parts. Some analysers provide on screen maintenance prompts.
Software and IT connectivity

Currently POCT patient results can be recorded directly into patients notes and QC
results into a specific log but electronic storage of results is preferable [24] and
becoming more common. Provision of electronic plotting of QC results on a Levey
Jennings plot is an efficient means of monitoring analyser performance. Welldeveloped analyser software is required for the secure electronic storage of results
together with the patient and operator identities needed for reliable result recall and
audit trails. It is therefore very important that entry of patient and operator IDs should
be mandatory, especially where multiple operators use the device. The ability to send
the results to a laboratory information system (LIS) or hospital information system
CEP08057: June 2009
14
(HIS) and in the future to an electronic patient record requires a good IT connectivity
system.
Good software features suggested during an ergonomic assessment were:
selection of results by a variety of identifiers e.g. date, patient, lot number

bar code use
infrequent/untrained user lockout
timed countdown to result availability
error code with description and solutions on the screen
electronic system checks as back up to QC measurement.
Some POCT devices, such as blood gas analysers, can be supplied with an IT
connectivity package enabling such activities as transmission of results to a LIS and
remote monitoring of analyser performance from the laboratory. Connectivity
packages are less common amongst smaller POCT devices such as those for
measuring HbA1c and or urine albumin and ACR, but there is a move towards greater
provision. The most important features of a good connectivity system have been
outlined by the CLSI [30] and include:
bi-directional connectivity
standard connections e.g. plug and play
compatibility with commercial software
secure passage of information much of which may be confidential
not likely to cause any delay to the use of the POC result
ease of use intuitive and functionally simple
availability of remote access
real time verification of patient and operator IDs.
IT connectivity is more important to point of care co-ordinators and support staff than
device operators. The most desirable features listed during an ergonomics
assessment were:
remote checking of QC and calibration

monitoring analyser status in real time
maintenance alerts when there is maintenance outstanding
stock control system
easy downloading to LIS
maintenance of operator training and competency registers
good archiving facilities.
Bi-directionality is useful but not so relevant to small POCT analysers since most do
not carry on-board QC materials. Connectivity systems that include remote real time
CEP08057: June 2009
monitoring of analyser activity allow POCT support staff to use their time most
effectively.
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Economic considerations
16
Published evidence on cost-effectiveness

HbA1c
There is limited evidence indicating that POCT for HbA1c will result in an economic
benefit [28]. DCCT and UKPDS trials established that there is an economic benefit
from tight glycaemic control with long-term health benefits even though there are
short term cost increases [5, 7].
Although POCT monitoring of HbA1c is more costly than laboratory measurement,
savings could be achieved in long-term healthcare due to better control of HbA1c
levels and the number of clinic visits can be substantially reduced [31-33].
Albumin
POCT measurement of low concentration urine albumin or ACR can be used to
screen out patient samples which are negative for microalbuminuria and therefore
reduce the number of samples sent to the laboratory for measurement. One UK
hospital that funds the supply of suitable urine reagent strips to local GP practices
found a 60% drop in the number of samples sent to the laboratory for urine albumin
measurement, making their scheme cost neutral [34].
Views differ on the cost effectiveness of POCT screening for microalbuminuria.
Kiberd and Jindal [35] found the cost per Quality Adjusted Life Year (QALY) was high
and more information on the effects of screening was required. Davidson and Croal
recommended screening at POC even though they found a 35% increase in
measurement cost/investigation (including laboratory confirmation of POCT positive
tests). The turnaround time for results was greatly reduced and 93% of the clinicians
found it helpful to discuss the result with the patient at the same visit [36].
Suggested costs of implementing the recommendations of NICE guidance on chronic
kidney disease [14] have been calculated in the costing report which is part of this
guideline [37]. ACR measurement is more expensive than PCR measurement but
there is considerable variation between suppliers and economies of scale may
decrease the unit cost with increased use of ACR. The model is based on the
following costs: ACR 2.16; PCR 1.42 and urine reagent strip (URS) 0.21. There
would be savings on URS and PCR costs but the overall cost rise for increased ACR
testing for patients with an estimated glomerular filitration rate (eGFR) of
< 60 ml/min/1.73m2 was calculated as 2.69 million. The estimated cost of assessing
those at increased risk of chronic kidney disease as indicated by family history or the
presence of other diseases such as hypertension, diabetes or cardiovascular disease
was 8.6 million. Quantitative POC measurement of ACR would increase these costs
but the benefits to the patient in instant results and decreased travel and
appointments should be added to the benefits of decrease in kidney disease
progression and delay in end stage renal disease requiring haemodialysis (estimated
annual cost 29,800/patient).
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Potential costs and benefits

When deciding if a point of care service should be provided, consideration must
be given to the clinical need, the effect on service provision and costs [24].
Costs will include:
purchase of equipment with the necessary features and software

running costs of the tests
internal and external quality control measurements
space for the POCT analysers
storage of the consumables e.g. refrigeration
operators time
disposal of consumables and analyser
technical staff support time for maintenance and troubleshooting
IT connectivity system including the interface to the LIS/HIS
maintenance contracts with the supplier for both the equipment and the
interface
training by the supplier or in-house staff time to supply cascade training
competency / proficiency testing of new and existing operators.
Potential savings and benefits of POCT to the patient and healthcare organisation:
reduced travel if the patient is seen in primary care

reduced turnaround time for the sample result
reduced number of patient appointments needed
negative screening tests for microalbuminuria reduces the need for
quantitative laboratory tests
positive effect on patient motivation to achieve better control of diabetes
since results can be discussed with the doctor at a single appointment
immediate treatment change, when appropriate, giving better continuity of
care.
An organisation may have to pay more for POCT than laboratory testing but can
benefit from reduced treatment costs, including those for hospital admissions [24].
Costs
Whole-life costs
Calculation of whole life costs of providing an analyte measurement should include
the lifetime of the analyser, the costs of the analyser and consumables and their
disposal, the cost of power consumed and the cost of laboratory staff support and
supplier servicing for the analyser. The cost of the operator time should also be
included.
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Cost of analysers
The purchase prices reflect the complexity of the analysers. The more expensive
analysers generally have more features and better software. None of the devices or
consumables for POCT measurement of HbA1c or urine albumin is currently on the
drug tariff.
Cost of analyser consumables
Self contained cartridges or cuvettes are more expensive than multiple component
consumables. The number of analytes measured by the cartridge/cuvette is not
always reflected in the cost.
Urine reagent strips provide the least expensive urine albumin measurements but
they do not provide quantitative results.
Pricing is often volume-dependent and potential customers should always obtain a
quote from the supplier before making any procurement decision.
Costs of operation
The cost of refrigerated storage space should be considered. Minimal refrigerated
space may be needed at POC, sufficient only for QC material, but much more may
be needed in the laboratory for consumable stocks (eg cartridges). Device
maintenance should be minimal and cost very little. The majority of waste is
biohazardous, and will incur some additional disposal costs. The bulkiest
consumables are the single use cartridges.
Servicing costs/extended warranty
The price of service contracts reflects the complexity of the analyser (tables 1-3).
Value added features

These features may affect the quality of the result or service provided, the analysis
time or the costs of the service, but all can also be viewed in terms of economic
benefits.An analyser has greater potential if it can offer additional analyte
measurements especially if the transition from one to another is quick and simple.
Quantitative methods require smaller patient sample volumes which can be an
important factor, particularly for children. Analysers with either or both of these
features could provide savings in space, staff training and purchasing and running
costs. Provision of an on-board printer saves the space and cost required for a
separate printer.
A robust system for the prevention of measurement and reporting errors can help to
minimise costs (including legal costs) associated with inappropriate and ineffective
CEP08057: June 2009
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treatment. Use of an external bar code reader can reduce data entry errors.
Mandatory entry of patient and operator IDs would allow the use of IT connectivity
packages. These allow the transfer of patient results with their patient and operator
IDs to the LIS and/or HIS thus facilitating audit. The facility to print results allows
them to be placed into the patients notes removing the risks of transcription errors.
Mandatory QC measurement and QC lockout if the QC results are out of range
ensure that the analyser is only used when functioning properly. Automatic reading of
urine reagent strips avoids subjective reading and result recording errors.
Some features can provide savings in staff time. The optimum analysis time in a
clinic is less than 4 minutes although 5-6 minutes would be acceptable. The ability to
print results onto labels allows direct attachment to the patients notes saving
operator time. Automatic reading of urine reagent strips reduces operator time. Use
of a bar code reader and an IT connectivity package both permit efficient use of
operating and support staff time. A well developed IT connectivity system would also
allow for secure long-term storage and retrieval of results by all healthcare
professionals involved with the patient. The time taken for training will reflect the
complexity of the device and the range of features. Most suppliers offer initial training
free of charge but further training sessions on site may incur charges. Training
generally requires 1-2 hours for an analyser and 30-45 minutes for very simple
devices such as urine reagent strips. Some suppliers do not offer any training
sessions. Specific information provided by suppliers to assist with cascade training
will save time for hospital staff responsible for these issues.
The cost of a POCT service is influenced by the need for quantitative or nonquantitative results, dictated by clinical requirements. Single cartridges specifically for
checking the optics temperature and electronics of the analyser can be used
repeatedly to check the functioning of the analyser between liquid QC measurements
without incurring the cost of measuring a liquid QC. The cost of an interface between
the connectivity package and the LIS will probably be the responsibility of the
customer not the supplier. Any charges incurred in the exchange of a faulty analyser
for a working one during repair need to be balanced against the impact on the patient
of not providing the test results for the clinic.
CEP08057: June 2009
Purchasing
20
Purchasing procedures
The Trust Operational Purchasing Procedures Manual provides details of the
procurement process [38].
European Union procurement rules apply to public bodies, including the NHS, for all
contracts worth more than 90,319 (from January 1st 2008) [39] (appendix 2). The
purpose of these rules is to open up the public procurement market and ensure the
free movement of goods and services within the EU. In the majority of cases, a
competition is required and decisions should be based on best value.
NHS Supply Chain (NHS SC) offers national contracts or framework agreements for
some products, goods and services. Use of these agreements is not compulsory and
NHS organisations may opt to follow local procedures.
Purchasing options
This type of analyser has three main purchasing options. Outright purchase and
lease purchase are straightforward. Reagent rental involves provision of an analyser
in exchange for a guaranteed purchase of reagents over the contract period.
Purchasing considerations for local use

The following issues should be considered:
space and the cost of preparing the location for POCT measurements in
accordance with health and safety regulations eg at a GP surgery
need for quantitative or non-quantitative test
need for one or more analyte results
number of tests likely to be performed
stability of reagents
refrigerated storage space
IQC and EQA availability and requirements
funding availability and source
ease of use in relation to staff who will use the device, including removal of
any subjective steps
maintenance requirements relative to available staff
level of device software development relative to audit requirements
desirable test time
reporting of results - electronic, paper/labels, manual transcription
on-board data storage capacity, especially if connectivity not available
connectivity availability for linking to local IT system allowing central
monitoring from laboratory can be very useful if few POCT support staff.
CEP08057: June 2009
Purchasing
21
Some manufacturers claims to provide a connectivity system may be misleading.

They may not be able to provide a working demonstration of the device being
interfaced since the provision of an interface is usually the responsibility of the
customer. This can be developmental work with additional hidden costs. There are
very few, if any, truly open connectivity systems able to connect to devices produced
by all manufacturers. As a result several separate data streams may have to come
into the LIS and/or HIS.
Supplier stability
Large multinational companies with significant resources are generally more
economically stable than relatively small individual companies. But the stability of
such an individual supplier can be indicated by how long they have been in the
market.
Sustainable procurement
The UK Government launched its current strategy for sustainable development,
Securing the Future [40] in March 2005. The strategy describes four priorities in
progressing sustainable development:
sustainable production and consumption working towards achieving more with
less
natural resource protection and environmental enhancement protecting the
natural resources and habitats upon which we depend
sustainable communities creating places where people want to live and work,
now and in the future
climate change and energy confronting a significant global threat.
The strategy highlights the key role of public procurement in delivering sustainability.
This section identifies relevant sustainability issues and provides some guidance on
how these can be incorporated into procurement decision making processes.
Significant sustainability issues for these devices are the source of materials from
which the analysers and consumables are manufactured and their safe disposal after
use. Packaging is also an important consideration. Power consumption is less
significant as it is low.
Materials
There is a high level of plastic use in the manufacture of the devices and their
consumables therefore the choice of plastic type has the potential to make a marked
impact on the sustainability of the products. Manufacture of the devices and their
consumables does not currently use any recycled materials (recyclate), nor any
CEP08057: June 2009
Purchasing
22
natural materials therefore none of the materials can be sourced from renewable
resources.
Disposal of consumables
Generally used consumables and single use devices will be disposed of in existing
containers for biohazardous waste in the clinical areas where they are used,
therefore it is important to generate the minimum volume of waste from POCT.
Cuvettes and urine reagent strips generate the smallest volume of waste, whereas
single use cartridges are relatively bulky.
Packaging
Consumable packaging can consist of individual spray foil wrapping, a cardboard box
which has an outer cellophane wrapper on some products. Some IFUs are shrink
wrapped in plastic within the box. None of this material is recyclable if it has been in a
clinical area as it may have been contaminated and must be disposed of as a
biohazard. Outer packaging used for transport of the consumables will usually be
recyclable and in some instances is made from recyclate; in other instances virgin
materials are used but they are sourced from Forest Stewardship Council (FSC)
certified sustainable sources.
Batteries, power supply and energy consumption
A minority of this type of analyser can use battery power including rechargeable
batteries. All the analysers are intended for use at room temperature and their power
consumption is very low (tables 1-3).
Power saving features are few, but some analysers automatically switch to standby
mode after a short period of inactivity. A few of the analysers utilize LEDs to reduce
energy demand (tables 11 and 12).
Noise output
The noise output of the analysers falls well below the Health and Safety Executive
recommended noise reduction action limits of 85 dBA or 140 dB [41].
End of life disposal
Consideration should be given to the likely financial and environmental costs of
disposal at the end of the products life. Where appropriate, suppliers of equipment
placed on the market after the 13th August 2005 should be able to demonstrate
compliance with the UK Waste Electrical and Electronic Equipment (WEEE)
regulations (2006) [42]. The WEEE regulations place responsibility for financing the
cost of collection and disposal on the producer. Electrical and electronic equipment is
exempt from the WEEE regulations where it is deemed to be contaminated at the
point at which the equipment is scheduled for disposal by the final user. However, if it
CEP08057: June 2009
Purchasing
23
is subsequently decontaminated such that it no longer poses an infection risk, it is

again covered by the WEEE regulations, and there may be potential to dispose of the
unit through the normal WEEE recovery channels.
Currently suppliers of these analysers are compliant with the WEEE regulations.
Aspirational discussion
Use of recyclate
For plastic recyclate to be used for the cartridges and cuvettes it would need to be of
optical quality. If plastic recyclate cannot be used, biodegradeable plastic would
reduce the environmental impact of the waste. Use of biodegradeable plastic might
be more appropriate for packaging materials, where the same benefit would arise.
IT connectivity
Further IT integration of POCT devices with bedside monitoring devices to allow all
results to be displayed on a single screen could provide the clinician with an instant
view of patient status. A similar development for laboratory results could include
POCT where it is linked to the LIS. This would aid the provision of the optimum
treatment and shorter patient stay, with possible cost savings. These developments
and the linking of results to the electronic patient record accessed across different
healthcare providers could reduce the risk of test duplication and also reduce the
amount of paper generated in recording/reporting results. This may bring savings to
the patient, the healthcare provider and the environment.
CEP08057: June 2009
Market review
24
Introduction
This market review includes all devices for point of care measurement of HbA1c and
low concentration albumin in urine on the UK market in June 2008. All the devices
are CE marked. The prices quoted are list prices (Spring 2008); discounts may be
available.
The analysers included in this guide could be used in a diabetic clinic setting within
secondary care and some are suitable for use within primary care if demand is
sufficient. The urine reagent strips are often used in primary care. Any grade of
appropriately trained staff could use these devices with one exception which required
laboratory trained staff. Axis Shield now market the NycoCard only for laboratory use
since the procedure includes pipetting which is a laboratory skill.
The information presented in the market review tables 1-3 was selected and
gathered from the following sources:
stakeholders following consultation on the best information to include

specification data for all devices from the manufacturers or suppliers
a small survey on sustainable development conducted with the
manufacturers and suppliers of these devices. Comparable information
from this is presented in tables 11 and 12
ease of use ratings gathered from an ergonomic assessment conducted
by evaluators and potential users, tables 5 and 6
a survey of device users was conducted during June-August 2008.
Where possible at least 6 users of each device were contacted (tables 58).
A five point scoring system was used for the ergonomic assessment and user survey
(very poor to very good). The results were translated into a three star rating system
(Satisfactory, Good, Very good) for tables 5-8 with a poor rating
for
poor and very poor scores.
The specifications of the devices are detailed in tables 1-3. The results of a limited
technical evaluation are discussed (page 36) and tables and graphs of the results are
presented in appendix 3.
CEP08057: June 2009
Market review
25
Table 1. HbA1c quantitative measurement comparative table (page 1 of 4)

Device
A1cNow+
Afinion
DCA Vantage
in2it
NycoCard
2007
2007
2007
2008
2000
Methodology basis
Immunological
Boronate affinity
Immunological
Boronate affinity
Boronate affinity
Calibration traceable to:
IFCC standard
IFCC standard
IFCC standard
IFCC standard
IFCC standard
4-13
4-15
2.5-14
4-14
3-18
Cartridge
Cartridge
Cartridge
Cartridge
Test disc
Sample volume (L)
1.5
10
Analysis time (min)
3.25
6.5
10
Advice only
2 levels
2 levels
2 levels
2 levels
HbF, HbS, HbC and

others
No effect of HbAS,
HbAE, HbF, HbS or HbC
HbF >10%, HbS, HbC,

HbE
No effect of Hb S and
HbD
No effect of HbAC,
HbAD, HbAE, HbF,
HbAJ, HbAS
UK launch date
Analysis information
Reportable range HbA1c (%)

Measurement consumable
Quality control material supplied

Affected by Hb variants
Electronics check
CEP08057: June 2009
During analysis
During start up
1 self-test/day if analyser
left switched on
During start up
Optics cartridge
During start up
Test cartridge
Calibration check
Market review
Device
26
A1cNow+
Afinion
DCA Vantage
in2it
NycoCard
Troubleshooting information on
screen
Error codes
Error codes
Error codes, explanation

+ resolution
Error code + brief

explanation
Error messages
Consumable storage long-term
2-8C
2-8C
2-8C
2-8C
2-8C
Consumable storage at room

temperature
90 days
90 days
90 days
30 days
Reagent 2 + discs
only, to expiry date
Waste collection and disposal
Used cartridge
biohazard
Used cartridge
compressed, biohazard
Used cartridge liquid

absorbed, biohazard
Used cartridge
biohazard
Used disc and pipette

tips, biohazard
None
ACR, CRP
ACR
None
Albumin, D-Dimer,
CRP
N/A
N/A
Minimal
Brief + symbols
Concise
Minimal symbols
Brief
N/A
Patient only
N/A
Mandatory QC + lockout
9both
9 mandatory QC
Locked while analysing
N/A
N/A
Printer and use of labels
N/A
External
On-board + labels
External + labels
None
500 P + 500 QC
4000 P + QC
200 P + QC
1 until next test
Patient trending
N/A
8 but planned
Other analytes measured

Bar code reader available
Touch screen
On-screen procedure instructions
Mandatory ID entry
Analyser result storage (Patient +

QC)
Data management on-board
Connectivity currently available
CEP08057: June 2009
Market review
Device
27
A1cNow+
Afinion
DCA Vantage
in2it
NycoCard
53 x 80 x 15
170 x 320 x 170
287 x 277 x 254
130 x 120 x 100
200 x 170 x 70
68 g
5 Kg
3.88 Kg
0.840 Kg
0.540 Kg
Battery
Mains
Mains
Mains or batteries
Mains or batteries
Operation
4.5 Wh
< 100Wh
70 Wh
18 Wh
< 20 Wh battery
charge
Standby
10 nA
40 Wh
N/A
1 Wh
0 Wh
N/A
N/A
N/A
Portable
Transportable + C
Portable + C
Portable + C
Portable
At least 5
10k tests in 10 yr
10
N/A
3,995
3,989
1,500
534
Purchase
Purchase, reagent
rental, lease
Purchase, reagent
rental, lease
Purchase, reagent
rental
Purchase, reagent
rental
79 for 10 + monitor
70 for 15
91.08 for 10
60 for 10
83 for 24
7.90
4.66
9.11
6.00
3.46
Warranty
N/A
1 yr
1 yr
1yr
1 yr
Service contract / extended

warranty
N/A
360/yr
377/yr
None
None
Audit trail
General information
Size of analyzer (mm) W x D x H
Weight of analyser
Power supply
Power use
Use of rechargeable batteries

Portable + Case (C)
Analyser life span (yr)
Costs
Analyser
Analyser/consumable finance
options
Test devices
Cost / pack size

Cost / test
CEP08057: June 2009
Market review
Device
28
A1cNow+
Afinion
DCA Vantage
in2it
NycoCard
Replace faulty analyser to fix
9 just replace
9 if on contract
Additional training
250/session
88/h
450 + VAT/day
~200/day off-site
88/h
8.30-17.00 M-F
9.00-17.00 M-F
24 h/d, 365 d/yr
9.00-17.00 M-F
9.00-17.00 M-F
Fax, phone, email
Post, fax, phone, email,

website
Fax, email
Fax, phone, email
Post, fax, phone,

email, website
1-14d
1d, if order 1pm M-Th
3d
1d, 10d if from USA
1d, if order 1pm M-Th
Supplier support
Support staff hours and helpline
Consumable ordering options
Consumable delivery times
CEP08057: June 2009
Market review
29
Table 2. Urine albumin quantitative measurement comparative table (page 1 of 4)

Device
Afinion
DCA Vantage
HemoCue
NycoCard
2007
2007
2006
2000
Immunological
Immunological
Immunological
Immunological
Enzymatic + colorimetric
Colorimetric
N/A
N/A
ERM DA 470 *
CRM 470 *
CRM 470 *
CRM 470 *
SRM 914a
SRM 914a
N/A
N/A
Albumin (mg/L)
5 - 200
5 - 300
5 - 150
5 - 200
Creatinine (mmol/L)
1.5 - 30
1.3 44.2
N/A
N/A
Cartridge
Cartridge
Cuvette
Test disc
Sample volume (L)
3.5
40
18
50
Analysis time (min)
5.5
1.5
3.7
2 levels
2 levels
2 levels
2 levels
During start up + 1 self-test/day

if left switched on
During start up + optics

cartridge
During start up
Calibration check
UK launch date
Methodology
basis
Calibration
traceable to
Reportable
range
Albumin
Creatinine
Albumin
Creatinine

Electronics check
CEP08057: June 2009
Market review
Device
30
Afinion
DCA Vantage
HemoCue
NycoCard
Error codes
Error codes, explanation +

resolution
Error codes
Error messages
2-8C
2-8C
2-8C
2-8C
90 days
90 days
3 days, can use direct

from fridge
Reagent 2 + discs only to

expiry date
Used cartridge compressed,

biohazard
Used cartridge liquid

absorbed, biohazard
Used cuvette biohazard
Used disc + pipette tips

biohazard
HbA1c, CRP
HbA1c
None
HbA1c, D-Dimer, CRP
N/A
N/A
Touch screen
Brief + symbols
Concise
Brief
Patient only
N/A
N/A
9 both
N/A
Printer and use of labels
External
On-board + labels
External
500 P + 500 QC
4000 P+QC
600 P+QC
1 until next test
Patient trending
8 but planned
8 but planned
Troubleshooting information on screen

Consumable storage at room temperature
Other analytes measured

Mandatory ID entry available
Analyser result storage (Patient + QC)

Audit trail
CEP08057: June 2009
Market review
Device
31
Afinion
DCA Vantage
HemoCue
NycoCard
17 x 32 x 17
28.7 x 27.7 x 25.4
17.0 x 11.5 x 6.6
20 x 17 x 7
5 Kg
3.88 Kg
0.350 Kg
0.540 Kg
Mains
Mains
Mains
Mains or batteries
<100 Wh
70 Wh
30 250 mA
< 20 Wh during battery

charging
140 Wh
N/A
Not known
N/A
N/A
N/A
Transportable+C
Portable+C
Portable+C
Portable
At least 5
At least 15
10
3,995
3,989
595
534
Purchase, reagent rental, lease
Purchase, reagent rental,

lease
Purchase, reagent rental,

lease
Purchase, reagent rental
Cost / pack
70 for 15
91.08 for 10
87.50 for 50
83 for 24
Cost / test
4.66
9.11
1.75
3.46
1 yr
1 yr
2 yr
1 yr
360/yr
377/yr
75/yr
None
9 if on contract
88/h
450 + VAT/day
Annual FOC
88/h
General information
Size of analyzer (cm) W x D x H
Weight of analyser
Power supply
Power use
Operation
Standby

Portable + Case
Costs
Analyser
Analyser/consumable finance options
Test devices
Warranty
Service contract / extended warranty
Additional training
CEP08057: June 2009
Market review
Device
32
Afinion
DCA Vantage
HemoCue
NycoCard
9.00-17.00 M-F
24 h/d, 365 d/yr
8.00-18.00 M-F
9.00-17.00 M-F
Post, fax, phone, email, website
Fax, email
Post, phone, fax, email
Post, fax, phone, email,

website
1 d, if order 13:00 M-Th
3d
1 d if order by 16:00
1 d, if order 13:00 M-Th
Supplier support
* ERM-DA470 and CRM 470 are different names for the same material.
CEP08057: June 2009
Market review
33
Table 3. Urine albumin non-quantitative measurement comparative table (page 1 of 4)

Device
Clinitek Status
Microalbustix
Uritest 13 G
ImmunoDip
Micral-Test
2003
1998
Not known
2002
2001
Albumin
Colorimetric
Colorimetric
Colorimetric
Immunological
Immunological
Creatinine
Colorimetric
Colorimetric
Colorimetric
N/A
N/A
CRM 470
CRM 470
Not known
CRM 470
Human albumin
CAS 60-27-5
CAS 60-27-5
Not known
N/A
N/A
10 - 150
10 - 150
Neg - >100
Neg <18, Pos >18
Neg (<20) - 100
0.9 26.5
0.9 26.5
<0.9 - >26.4
N/A
N/A
Reagent strip
Reagent strip
Reagent strip
Reagent strip
Reagent strip
8-10 mL
8-10 mL
Too long for universal

bottle
12-14 mL
8-10 mL
1.25
1 must read by 2
3 must read by 8hr
1 must read by 5
2 levels (Neg/Pos)
2 level (Neg/Pos)
None
2 level
None
During start up
N/A
N/A
N/A
N/A
UK launch date
Methodology
basis
Calibration
traceable to
Reportable
range
Albumin
Creatinine
Albumin (mg/L)
Creatinine (mmol/L)
Sample volume in 25 mL universal
bottle (mL)
Analysis time (min)
Electronics check
CEP08057: June 2009
Market review
Device
34
Clinitek Status
Microalbustix
Uritest 13 G
ImmunoDip
Micral-Test
Troubleshooting information on
screen
Error codes,
explanation +
resolution
N/A
N/A
N/A
N/A
15-30C
15-30C
2-30C
18-26C
2-8C
Consumable storage at room

temperature
To expiry date
To expiry date
To expiry date
To expiry date
6 months
Used strip
biohazard
Used strip biohazard
Used devices
biohazard
Other Siemens
urinalysis strips and
Clinitest pregnancy
test
None
11 other routine
urinalysis analytes
None
None
N/A
N/A
N/A
N/A
Touch screen
N/A
N/A
N/A
N/A
Brief
N/A
N/A
N/A
N/A
Mandatory ID entry
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Printer + use of labels
On-board + labels
N/A
N/A
N/A
N/A
200 P+QC
N/A
N/A
N/A
N/A
Other devices/analytes measured

Analyser result storage (Patient +

QC)
CEP08057: June 2009
Market review
Device
35
Clinitek Status
Microalbustix
Uritest 13 G
ImmunoDip
Micral-Test
N/A
N/A
N/A
N/A
8 but planned
N/A
N/A
N/A
N/A
17.1 x 27.2 x 15.8
N/A
N/A
N/A
N/A
1.7 Kg
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
7.2 Wh
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Portable
At least 5
N/A
N/A
N/A
N/A
595
N/A
N/A
N/A
N/A
Purchase, reagent
rental, lease
Purchase
Purchase
Purchase
Purchase
Cost/pack
39 for 25
39 for 25
39.99 for 100
49.85 for 25
41.50 for 30 *
Cost/test
1.56
1.56
0.40
1.99
1.38 *
1 yr
To expiry date
To expiry date
To expiry date
To expiry date

Audit trail
General information
Size of analyzer (cm) W x D x H
Weight of analyser
Power supply
Power use
Mains or batteries
Operation
Standby

Costs
Analyser
Analyser/consumable finance options
Test devices
Warranty
CEP08057: June 2009
Market review
Device
Service contract/extended warranty
Additional training
36
Clinitek Status
Microalbustix
Uritest 13 G
ImmunoDip
Micral-Test
83/yr
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
450 + VAT/day
450 + VAT/day
Not known
100/10 trainees
No training
24 h/d, 365 d/yr
24 h/d, 365 d/yr
Not known
9.00-17.00 M-F
9.00-17.30 M-F
Fax, email
Fax, email
Medical supplies
catalogue
Post, phone, fax,

email
Phone, medical supplies

catalogues
3d
3d
Not known
2-7 d
1-5 d
Supplier support
* Prices effective from 1st April 2009
CEP08057: June 2009
Market review
37
Limited technical evaluation

Twenty one venous whole blood patient samples, preserved with EDTA, were
analysed in duplicate for HbA1c on each of the five analysers. Twenty two untimed
unpreserved urine patient samples were analysed in duplicate for albumin or ACR on
the four analysers and five urine reagent strips. Analyses were performed according
to the IFUs in a well lit laboratory. Quality control samples were measured on each
device at the beginning and end of each analytical session. The samples had been
previously measured in a clinical laboratory on a Menarini 8160 HPLC analyser for
HbA1c or Siemens ADVIA 2400 for urine albumin and creatinine (albumin: PEG
enhanced immuno-turbidimetric, creatinine: alkaline picrate) to provide results for
comparison.
Regression analysis was performed to compare each POCT method with the
laboratory method. Confidence intervals are an indication of imprecision. Average
bias of the results relative to the laboratory method was calculated only if the bias
was similar across the measured range of the results [43]. The results are presented,
together with the manufacturers claimed performance in appendix 3 (tables 24-27).
Figures 5-8 compare the performance of the quantitative methods with the laboratory
methods. The graphs for the non-quantitative results (figures 9-11) show the
laboratory method concentrations read to each colour block on the strip.
The results from the POCT devices are presented in tables 28-32 on which the cutoff
values recommended by NICE are also shown [12, 23]. The results for each analyte
are provided in ascending order according to the reference result with shaded cells
representing the clinically normal results according to the NICE cutoff values.
HbA1c
The in2it results gave the best agreement with laboratory results (table 24). At
concentrations close to the recommended targets HbA1c of 6.5 - 7.5%, Afinion, DCA
Vantage and in2it analysers provided results within 0.5% HbA1c of the laboratory
result. The DCA Vantage performed well up to 8.5% HbA1c but overestimated at
higher concentrations (figure 5). A1cNow + results had a negative bias which
exceeded the 0.5% expected with the use of EDTA preserved samples. Accuracy
data for most analysers agreed moderately well with manufacturers quoted
performance, the largest differences being shown by the A1cNow+ and the DCA
Vantage. The Afinion samples showed the lowest imprecision as indicated by the
confidence intervals.
The cutoff table (table 28) shows % HbA1c underestimation by A1cNow+ and
overestimation by NycoCard.
All the analysers have NGSP certification for 2008 and therefore have acceptable
performance. The analysers demonstrating the best analytical performance in this
study were the in2it, Afinion and DCA Vantage.
CEP08057: June 2009
Market review
38
Albumin
Quantitative: The DCA Vantage albumin method has the widest reporting range, up
to 300 mg/L, and it gave the best overall agreement with the laboratory method
(table 25) but with a positive bias at around 250 mg/L (figure 6). Confidence intervals
were similar for the DCA Vantage, Afinion and NycoCard. Accuracy data for the
analysers agreed with available manufacturers quoted performance. The average
bias on the HemoCue 201 albumin analyser (- 4.4 mg/L) was high in proportion to
the normal cutoff of 20 mg/L (table 25). This analyser had the greatest tendency to
underestimate albumin and might miss some cases of microalbuminuria. The bias of
the Afinion, NycoCard and DCA Vantage results was positive in the normal
cutoff/screening range so cases of microalbuminuria are unlikely to be missed, but
there may some false positives.
Non-quantitative: Cutoff table results (table 30) were difficult to compare since the
colour block concentration values were different across the devices.
Of the two immunologically based albumin dipsticks, ImmunoDip showed the better
ability to detect microalbuminuria reliably at the cutoff point, with Micral-Test
overestimating and therefore giving false positives (figure 9a). The Clinitek Status
provided slightly better accuracy for albumin than the visually read Microalbustix
which gave more false positives (figure 9b and table 30) although the Clinitek
Microalbumin and Microalbustix strips are identical in measurement pads. Some
samples gave poor duplicates on the reagent strips where the laboratory result was
midway between colour blocks: these are indicated in the table but were excluded
from the graphs.
Uritest 13G results were meaningless for albumin (figure 10a). The difference
between the three albumin colour blocks (negative, negative and equal to or
greater than 100 mg/L) was so small that it was difficult to assign results and all the
samples were read to the greater than 100 mg/L colour block.
ACR and creatinine
Quantitative: If either albumin or creatinine results are outside the reportable range,
the Afinion will not provide an ACR result but the DCA Vantage will eg. if the albumin
is > 300 mg/L and the creatinine is 2 mmol/L the ACR is given as > 150 mg/mmol.
Agreement between the results from the DCA Vantage or the Afinion and the
laboratory method at the cutoff point was good (table 31) but the DCA Vantage
results showed slightly better overall agreement (table 26). The Afinion confidence
intervals were slightly narrower than those for the DCA Vantage. Accuracy data for
the analysers agreed with available manufacturers quoted performance. The Afinion
and DCA Vantage both showed greater scatter at higher values for both creatinine
and ACR results (figures 7 and 8).
CEP08057: June 2009
Market review
39
Non-quantitative: Creatinine measurement using the Clinitek Status was good

although there were some poor duplicates midway between colour blocks which
were excluded. Creatinine at lower concentrations tended to be overestimated on the
visually read Microalbustix (figure 11a). Uritest 13G creatinine results showed no
clear relationship to the laboratory results (figure 10b).
ACR results (figure 11b plotted on a log scale) showed that the Clinitek Status
provided better discrimination between normal and abnormal ACR values than
Microalbustix. Only one sample with a raised ACR by the laboratory method gave a
normal Clinitek Status result and therefore a normal Clinitek Status result was a
good indication that ACR was within normal range; this agreed with another recent
study [44]. It was not possible to calculate meaningful ACR results from the Uritest
13G albumin and creatinine measurements.
The differentiation between normal and abnormal ACR using the non-quantitative
devices was poorer than that for the quantitative POCT devices (tables 31and 32).
Refinements to the Clinitek Status assessment of ACR showed its superiority to the
visually read Microalbustix.
Manufacturers claimed performance for albumin and ACR measurements on the
urine reagent strips shows that most fall just short of the recommended sensitivity of
> 95% [18] (table 27).
Overall conclusion for urinalysis
Quantitative: The NycoCard and DCA Vantage showed slightly better performance
for albumin measurement than the Afinion and HemoCue. The creatinine and ACR
measurements made by the DCA Vantage were marginally better than those by the
Afinion.
Non-quantitative: The Clinitek Status provided the most accurate measurement of
albumin and it gave slightly better creatinine and ACR results than Microalbustix.
The Uritest 13 G cannot be recommended for use due the difficulty in reading the
albumin results to the colour blocks and to the unsuitability of their concentrations to
the usual 20 mg/L cutoff point for microalbuminuria [23]. Creatinine colour blocks
were distinctive in colour but the results were still very imprecise.
CEP08057: June 2009
Market review
40
Training and instructions
The suppliers of these devices offer training to suit the customer, generally accepting
4-10 trainees per session. The suppliers also offer refresher training and some
literature to assist with training. Two suppliers of urine dipsticks (Uritest 13G and
Micral-Test) do not offer any training.
The IFUs and operators manuals supplied with these devices were assessed
against the British Standard (BS) En 591:2001 which specifies the IFU content
required for in vitro diagnostic devices, linked to the requirements of the IVDD. The
IFUs for these devices, with, one exception, met this standard.
Poor: Uritest 13 G
Acceptable: NycoCard, Micral-Test
Good: A1cNow+, Clinitek Status, HemoCue, ImmunoDip, in2it, Microalbustix
Very good: Afinion, DCA Vantage
Ergonomic assessment
A small ergonomic assessment was undertaken encompassing the views of
evaluators, point of care team members and diabetic clinic nurses (tables 5 and 6).
The NycoCard was rated unacceptable for POC use but the manufacturer now
states that it should only be used in a laboratory.
A limited user survey was also carried out. Sixty two questionnaires were distributed
of which 42 were completed (68%) (tables 5-8). The NycoCard users all worked in
laboratories which may have influenced their opinions. The in2it users were
evaluating the analyser in the laboratory not at POC. No users contact information
was supplied for the Uritest 13 G and only one user for the HemoCue 201 albumin.
In general the users rated the overall ease of use the same or better than
participants in the ergonomic assessment. The exception was the in2it.
Based on the features set out on page 12 and use at POC, the devices have been
ranked as follows (table 4).
Table 4. Device ranking in relation to best design features
Rank
(1 - best)
HbA1c analysers
Urine albumin analysers quantitative
Urine albumin devices

non-quantitative
DCA Vantage
DCA Vantage
Clinitek Status
Afinion
Afinion
ImmunoDip
in2it
HemoCue
Micral-Test
A1cNow+
NycoCard
Microalbustix
NycoCard
CEP08057: June 2009
Uritest 13 G
Market review
41
Table 5. HbA1c and urine albumin or HbA1c only measurement: ease of use assessment
Device
A1cNow+
Afinion
DCA Vantage
in2it
NycoCard
Clarity of short form instructions
Ease of loading capillary with sample
Ease of loading cartridge into analyser
Ease of entering required information
N/A
Number of operator dependent step in procedure
Clarity and content of results displayed on screen
Clarity and content of result printout
N/A
N/A
N/A
Overall ease of use
Information displayed on analyser status
User overall ease of use

Poor:
Satisfactory:
CEP08057: June 2009
Good:
Very good:
Market review
42
Table 6. Urine albumin only measurement: ease of use assessment

HemoCue
Clinitek
Status
Microalbustix
Uritest
13G
ImmunoDip
MicralTest
None
None
None
Ease of loading cartridge into analyser
Ease of entering required information
N/A
Number of operator dependent step in procedure
Clarity and content of result printout
Ease of dipping and blotting the strip
Convenience of read times
Ease of aligning strip correctly against colour chart
N/A
Ease of selecting correct result for strip
Device
Clarity of short form instructions
Ease of loading capillary with sample
Information displayed on analyser status

Clarity and content of results displayed on screen
Overall ease of use

User overall ease of use
Poor:
Satisfactory:
CEP08057: June 2009
Good:
Very good:
No users
Market review
43
Table 7. HbA1c and urine albumin or HbA1c only measurement: user assessment
Device
A1cNow+ (5)
Afinion (7)
DCA Vantage (7)
in2it (6)
NycoCard (5) *
Would like bar code reader

and printer (%)
N/A
50
100
75
N/A
Would like good IT links (%)
N/A
92
93
100
80
Maintenance and
troubleshooting
5/5
5/6
7/7
Training
Supplier support
Environmental
Recommend
Poor:
Satisfactory:
Good:
Very good:
3/6 (for POCT use)
5/5
*NycoCard user comments reflect laboratory use.
Table 8. Urine albumin only measurement: user assessment

Device
HemoCue (1)
Maintenance and
troubleshooting
Microalbustix (3)
Uritest 13G (0)
ImmunoDip (2)
Micral-Test (2)
N/A
No users
N/A
N/A
No users
None provided
No users
No users
1/1
4/4
3/3
No users
2/2
2/2
Training
Supplier support
Environmental
Recommend
Poor:
Satisfactory:
CEP08057: June 2009
Good:
Clinitek Status (4)
Very good:
Market review
44
Maintenance
Maintenance is minimal for most of these analysers, the main task being cleaning of
the exterior and measuring chamber which is particularly important for the Clinitek
Status where the sample is not enclosed in a cartridge. The DCA Vantage and
NycoCard have some minor parts which need monthly or quarterly replacement.
Only the DCA Vantage provides on-screen maintenance prompts.
Software and IT connectivity
The software available on these devices varied from the simple to the sophisticated.
The analysers were ranked according to the good software features listed on page
14.
1.
2.
3.
4.
5.
6.
7.
DCA Vantage
in2it
Clinitek Status
Afinion
A1cNow+
NycoCard
HemoCue
Several of the devices have IT connectivity facilities in development.
CEP08057: June 2009
Market review
45
Whole-life costs
The whole-life costs have been calculated from the lifetime of the analyser, plus
analyser, consumable and servicing costs. Costs of power consumed (tables 1-3)
and consumable disposal should be low. Analyser disposal costs will have to be
borne by the customer unless the analyser has been fully decontaminated. These
types of device are used by a range of staff grades which makes a meaningful
estimate of staff time costs very difficult.
Table 9. Whole life and annual costs for multiuse analysers
Device
Afinion
DCA
Vantage
HemoCue
in2it
NycoCard
Clinitek
Status
Whole of
life cost
(500)
17,695
28,644
14,845
31,500
17,694
4,910
Whole of
life cost
(1000)
29,595
51,416
27,970
61,500
35,394
8,810
Annual cost
(500)
3,539
5,729
990
3,150
1,797
982
Annual cost
(1000)
5,919
10,283
1,865
6,150
3,540
1,762
Table 10. Annual costs for limited use analyser and single use urine reagent strips
Device
A1cNow+
Microalbustix
Uritest 13 G
ImmunoDip
Micral-Test
Annual cost
(500)
3,950
780
200
997
657
Annual cost
(1000)
7,900
1,560
400
1,994
1314
The cost of 10 A1cNow+ measurements appears expensive but unlike consumable

packs for the other products the A1cNow+ pack includes the monitor for carrying out
the measurements. It is well suited to low throughput situations, is extremely portable
and requires little operator time. The NycoCard would be expensive in operator time.
Although the HemoCue 201 albumin is the least expensive method for measuring
urine albumin quantitatively it does not provide the ACR recommended by NICE [9].
The Hemocue cuvettes are the only POCT analyser consumables which cannot be
stored at room temperature for at least 1 month. The boxes of 25 cuvettes require
little space in the fridge.
The higher cost of the Clinitek Status semi-quantitative measurement of albumin
must be weighed against its operational advantages including its well developed
software. The cheapest test, Uritest 13 G, has inferior design features (table 4) and
inadequate technical performance (table 30).
CEP08057: June 2009
Market review
46
Purchasing
Supplier stability
A companys economic stability might influence the choice of supplier. Five of the
eight suppliers of these devices are large multinational companies with significant
resources. BHR and Chirus have been supplying a variety of POCT devices for 18
and at least 5 years respectively. Economed is a catalogue order supply company.
Decision trees
Figure 1. Choice of analyser according to analyte measured
Which
analytes?
HbA1c only
Urine albumin
/ACR only
In2it
A1cNow+
HemoCue
HbA1c and urine
albumin /ACR
Uritest 13 G
Micral-Test
Afinion
NycoCard
DCA Vantage
CEP08057: June 2009
Clinitek Status
Microalbustix
ImmunoDip
Market review
47
Figure 2. Choice of analyser measuring HbA1c and urine albumin
Quantitative?
No
Yes
Easy to use for

POCT?
Yes
No
NycoCard
Analysis time
< 4 minutes?
Yes
Record patient
& operator IDs?
No
Record patient
& operator IDs?
No
No
Yes
Yes
IT connectivity?
Afinion
IT connectivity?
No
No
Yes
Yes
CEP08057: June 2009
DCA Vantage
Market review
48
Figure 3. Choice of analyser measuring HbA1c only
Quantitative?
No
Yes
Easy to use for

POCT?
No
Yes
Analysis time
< 4 minutes?
Yes
No
Record patient
& operator IDs?
Yes
No
IT connectivity?
Yes
No
in2it
CEP08057: June 2009
A1cNow+
Market review
49
Figure 4. Choice of devices measuring urine albumin
Quantitative?
Yes
No
Easy to use for

POCT?
Easy to use for

POCT?
No
Yes
Yes
Analysis time
< 4 minutes?
No
Analysis time
< 4 minutes?
No
No
Yes
Yes
Record patient
& operator
IDs?
HemoCue
Uritest 13 G
Record patient
& operator
IDs?
No
Yes
Yes
Clinitek Status
No
Need stringent
timing?
IT
connectivity?
No
Yes
Microalbustix
Yes
No
Needs colour
matching?
Yes
Micral-Test
CEP08057: June 2009
No
ImmunoDip
Market review
50
Sustainable development
Sustainable development is a growing issue. Questionnaires covering various aspects of sustainable development were sent to
each supplier. Responses were mixed and it is recognised that many companies are only just starting to take these issues into
consideration in their production systems. Tables 11 and 12 summarise the comparable information received.
Table 11. HbA1c and urine albumin or HbA1c only measurement: sustainable development issues
Device
A1cNow+
Afinion
DCA Vantage
in2it
NycoCard
Power saving features
N/A
None
Automatic switch to power

save after 30 min
Automatic switch to
standby after 20 min
Automatic switch to
standby after 10 min
Designed for ease of maintenance

and repair
N/A
Only at manufacturer
9 for reader pen
Operation
50 dBA
48 dBA
< 65 dBA at im
Standby
N/A
Not known
Not known
Not known
None but virgin materials

from sustained forestry.
None
Audible noise
output (dBA or
dB)
Percentage of the packaging from

recyclate
Table 12. Urine albumin only measurement: sustainable development issues

Device
Power saving features
Designed for ease of
maintenance and repair
Audible noise
output (dB)
Operation
Standby
Percentage of the packaging

from recyclate
CEP08057: June 2009
HemoCue
Clinitek Status
Microalbustix
Uritest 13 G
ImmunoDip
Micral-Test
None
None
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Minimal
17.8 dB
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Not known
Not known
Not known
Not known
75-100 outer boxes and foil for transport .

Virgin materials from FSC certified sources.
Market review
51
Summaries
The information gathered for this report is summarised in 11 device specific tables (tables 13-23).
Table 13. A1cNow+ summary
A1cNow+
Strengths
Lightweight and convenient
Easy to use
Sample size 5 L
Walk away once monitor loaded with cartridge
Clear time countdown during analysis
Electronic checks during measurement
CEP08057: June 2009
Overall rating: Satisfactory for a quantitative system

Limitations
IFU sheet very large
Awkward multi-step sample preparation
No patient or operator ID entry
Result only displayed for 20 min, no memory
Immunological method susceptible to
haemoglobin variant interference
Small size increases risk of losing device
Expensive
Not possible to remove battery before
disposal
Summary
The A1cNow+ is a very small disposable monitor used
with single use cartridges for HbA1c measurement. It
is supplied as a pack containing everything needed
for 10 measurements.
Consumable storage: room temperature for up to 90
days
Performance assessment: underestimation relative
to laboratory measurements which might result in
under-treatment of the patient
Overall ease of use: rated satisfactory by the
ergonomic assessment and good by the users
Training quality: generally good but one user had not
received any
Recommended by users: 5/5
Potential use: low sample throughput situations such
as the GP surgery or in the home performed by a
community nurse; less suited to use in a busy clinic
Market review
52
Table 14. Afinion summary
Overall rating: Good for a quantitative system
Afinion
Strengths
More than one analyte can be measured
Boronate affinity methodology for HbA1c
Straightforward to use, no capillary wiping
Cartridge and capillary holder barcoded
Patient ID displayed during measurement
Walk away once analyser loaded
Locked analysis compartment during
measurement
Short analysis time (3.5 min HbA1c, 5.5 min
ACR)
Good liquid containment in used cartridge
Screen result in large font
Easy recall of previous results
Reliable
Compact and transportable
CEP08057: June 2009
Limitations
Icon only screen instructions
No spare capillaries
No prompt to enter operator ID for each
sample
Poor QC solutions material, hard to resuspend
No QC lockout, on-board QC ranges or QC
programme
No real time countdown during analysis
Error codes only on screen, need manual
for resolution
No on-board printer
Lack of IT connectivity
Summary
The Afinion is a fairly small analyser using single use
cartridges for HbA1c, ACR or CRP measurement.
External barcode reader and printer are available.
days
Performance assessment: good agreement with
laboratory results for HbA1c and ACR
Overall ease of use: rated good, but use of words and
symbols in instructions would be clearer than symbols
alone
Training quality: generally good
Potential use: in a clinic
Market review
53
Table 15. DCA Vantage summary
DCA Vantage
Strengths
Straightforward to use, clear on-screen
instructions
Entry of IDs can be mandatory, audit trail
possible
QC lockout if QC not measured, maintenance
prompts
Optical check cartridge for electronics check
Timed count down during analysis
Clear screen results, graphical patient result
trending
Reliable results and good EQA results
Results can be printed on labels and
downloaded to computer
Errors codes explained, solutions given onscreen
IT connectivity potential
Ease of training
CEP08057: June 2009
Overall rating: Good for a quantitative system

Limitations
Relatively quite large and heavy, not very
portable
Patient ID not shown during analysis
Card bar code swiping adds to procedure
steps
Short sample if capillary wiping technique
poor
6 or 7 min analysis time too long if clinic very
busy
Awkward cartridge removal
Liquid leak from some used cartridges on
disposal
Printout result font too small
No on-board QC programme
Security settings insufficient for POCT policies
Need interface to LIMS
Immunological method susceptible to
haemoglobin variant interference
Thermal printer
Summary
The DCA Vantage is medium sized analyser using
single use cartridges for HbA1c or ACR measurement.
An external barcode reader is available.
days
Performance assessment: HbA1c reasonable
agreement with laboratory results, but a tendency to
overestimate above an HbA1c concentration of 9%;
very good agreement of ACR results up to an ACR of
at least 15 mg/mmol
Overall ease of use: rated good
Training quality: generally good but the experience
of some users was mixed
Potential use: in a clinic, but more than one analyser
would be needed for busy clinics especially if ACR
measurements were made as well as HbA1c, due to
the time taken for each analysis
Market review
54
Table 16. in2it summary
in2it
Strengths
Small footprint and light weight
Boronate affinity methodology
Very simple to use
No capillary wiping
Clear time count down during analysis
System check cartridge for electronics check
Clear result on screen and printout
Minimal maintenance
Results can be printed on labels and
downloaded to computer
Good for low sample throughput
CEP08057: June 2009

Limitations
Comes in parts therefore lots of leads and
more space needed than for analyser alone
Keypad is numeric only
2 hours to warm up cartridges from fridge
Long analysis time (10 min)
Patient ID not displayed during analysis
Noisy
Error codes only on screen, need manual for
resolution
QC material only stable 1 week
Limited memory, need regular download to
computer
Thermal printer
Summary
The in2it is a small analyser using single use
cartridges for the measurement of HbA1c. External bar
code reader, numerical keypad and printer are
available and if used additional space is required.
days
laboratory results and a low average bias
Overall ease of use: rated good by the ergonomic
assessment and satisfactory by users (laboratory
staff assessing the analyser)
Training quality: generally at least satisfactory
Potential use: in a clinic, but more than one analyser
would be needed in a busy clinic because of the time
taken for each analysis
Market review
55
Table 17. NycoCard summary
Overall rating: Poor for a quantitative system
NycoCard
Strengths
Boronate affinity methodology for HbA1c
No complicated calibrations
No capillary wiping
Same volume for all additions of liquid in one
test
Staff training good
CEP08057: June 2009
Limitations
No ACR
Screen very small
No patient or operator ID entry
Too many awkward steps throughout the
procedure
Timer required
Memory only 1 result
Not interfaced with computer
Turns itself off too quickly (10 min)
Summary
The NycoCard is a small analyser using different kits
for the measurement of HbA1c, urine albumin, CRP
and D-Dimer. Axis Shield now only market the
NycoCard for laboratory use.
Consumable storage: part of the kit refrigerated, part
at room temperature until expiry date
Performance assessment: overestimation of HbA1c
compared to laboratory results and good agreement
of urine albumin results
Overall ease of use: rated unacceptable for POCT by
the ergonomic assessment but good by the users as
they all used the device in a laboratory
Training quality: good
Recommended by users: 5/5 for use in a laboratory
Potential use: in a laboratory for low sample
throughput
Market review
56
Table 18. HemoCue summary
HemoCue
Strengths
Ease of use
Small sample size
Short analysis time
Good memory capacity for the size of analyser
Results can be downloaded to a computer if it
is connected during analysis
CEP08057: June 2009

Limitations
No ACR
No patient or operator ID entry, also limits
memory use
Short sample if cuvette wiping technique poor
Awkward placing of cuvette in analyser
No actual time countdown during analysis
Error codes only on screen, need manual for
resolution
Thermal printer
Summary
The HemoCue 201 albumin is a small analyser used
with single use cuvettes. A printer is available,
requiring additional space.
Consumable storage: can be kept at room
temperature for 3 days. Can be used straight from
the fridge if care is taken to remove any condensation.
Performance assessment: some underestimation in
comparison with laboratory results; average bias was
negative and quite high in relation to the normal cutoff
concentration
Overall ease of use: rated good in the ergonomic
assessment and very good by the user
Training quality: good but the user found training
given too early in relation to regular use of analyser
Potential use: in a clinic but the lack of ACR is a
shortcoming and therefore does not meet current UK
clinical guidance [9]
Market review
57
Table 19. Clinitek Status summary
Clinitek Status
Strengths
Multi-purpose reader detecting alternative
strips automatically
More than one analyte is measured on the
Clinitek Microalbumin strips
Sample quality can be recorded
Ease of use
ACR estimation provided, using optical
readings
On-board printer
Reduces operator error
Results are accurately timed
Removes operator subjective strip reading
CEP08057: June 2009
Overall rating: Very good for a non-quantitative system

Limitations
Semi-quantitative
Instructions on bottle and IFU sheet do not
match exactly
Dip, wipe and load time (8 s) very short
Regular cleaning of tray and calibration strip
important
Thermal printer
No power saving features
Summary
The Clinitek Status is a fairly small analyser used for
automatic reading of urine reagent strips (Multistix or
Microalbustix) and Clinitest pregnancy test palettes. It
provides an accurately timed, non-subjective reading
which is electronically recorded. It does not rely on the
quality of the operators colour vision or the ambient
lighting, vital for the accurate visual reading of other
urine reagent strips.
Consumable storage: permanently at room
temperature
laboratory results for albumin and ACR given the
semi-quantitative nature of the results
Training quality: good
Potential use: in a clinic or ward setting; even a busy
clinic may only require one analyser as measurement
time is short
Market review
58
Table 20. Microalbustix summary
Microalbustix
Strengths
More than one analyte is measured on these
strips
Easy to use
ACR estimation available
Minimum space required
Quick test
Long shelf life
Overall rating: Satisfactory for a non-quantitative system

Limitations
Semi-quantitative
Different languages on ACR chart confusing
Dependent on subjective result reading
Requires ambient lighting and operator colour
vision of a set standard
Requires stringent timing of result reading
Analyte reading times close together (10 s)
Manual result recording
Summary
Microalbustix is a urine reagent strip for the semiquantitative measurement of urine albumin and
creatinine concentrations. A chart is provided to read
off an approximate ACR result but this is a ratio of two
semi-quantitative results. Microalbustix should be
read in a well lit area by a well-trained user with good
colour vision. A timer should be used for accurate
result reading. There should be a reliable system of
manually recording the results. Use of an automatic
urine reagent strip reader would be preferable to
visual reading.
temperature
Performance assessment: some slight
overestimation at lower albumin concentrations
potentially giving rise to some false positive cases of
microalbuminuria
Training quality: generally satisfactory
Potential use: in a clinic or on a ward
CEP08057: June 2009
Market review
59
Table 21. Uritest summary
Uritest 13G
Strengths
Albumin and creatinine measurements
available plus 11 other analytes
Minimum space required
Quick test
Long shelf life
CEP08057: June 2009
Overall rating: Poor for a non-quantitative system

Limitations
Semi-quantitative
Strip too long to fit into universal container for
dipping
Need to rest dipped stick on colour chart to
check block alignment with chart
13 results all to be read and recorded within
one minute
Minimal difference in colour between albumin
chart colour blocks
Albumin chart block concentrations do not
show what concentratons are considered
negative
Summary
Uritest 13G is a urine reagent strip for the semiquantitative measurement of 13 urine analytes
including albumin and creatinine.
temperature
Performance assessment: very poor; very difficult to
discriminate between the albumin colour blocks and
readings across the concentration range were all at
the highest value colour block on the chart,
agreement of creatinine results with those from the
laboratory was not consistent even allowing for their
semi-quantitative nature
Overall ease of use: rated unacceptable by the
ergonomic assessment; no users for user survey
Training quality: no training offered, no IFU on visual
reading of the strip provided; these sourced from the
internet by the evaluator
Recommended by users: no users
Potential use: Uritest 13G strips not recommended
for use on the grounds of inadequate analytical
performance, poor design and complete lack of
supplier support
Market review
60
Table 22. ImmunoDip summary
ImmunoDip
Strengths
Immunological method
Ease of use
Good IFU
Requires colour intensity matching not colour
shade matching unlike other urine reagent
strips
Long shelf life
CEP08057: June 2009
Overall rating: Good for a non-quantitative system

Limitations
Qualitative
No ACR
Requires good ambient lighting and visual
ability to discern differences in blue line
intensity
Minimum read time (3 min) quite long for a
urine dipping device.
Need a rack to stand urine container in during
dipping to avoid spillage
No automatic reader available
Expensive
Summary
ImmunoDip is a device for the qualitative detection of
albumin in urine; negative cutoff is 18 mg/L. It should
be read in a well lit area by a well-trained user. There
should be a reliable system of manually recording the
results. Use of an automatic strip reader would be
preferable to visual reading.
temperature
laboratory results given the qualitative nature of the
results
Overall ease of use: rated good by the ergonomic
assessment and very good by the users
Training quality: good where it was provided but one
user had not received any
Potential use: in a clinic or on a ward, low sample
throughput; less suitable for busy clinic
Market review
61
Table 23. Micral-Test summary
Micral-Test
Strengths
Immunological method
No blotting required
1-5 min reading period
Quick test
Colour of different chart blocks distinctive
Long shelf life
CEP08057: June 2009
Overall rating: Satisfactory for a non-quantitative system

Limitations
Semi-quantitative
No ACR
Care needed to dip correctly
Different colour reading convention compare
to other urine reagent strips
No training may result in incorrect use and
wasted strips.
Summary
Micral-Test is a urine reagent strip for the semiquantitative measurement of urine albumin
concentration. Micral-Test should be read in a well lit
area by a well-trained user with good colour vision
and a timer. There should be a reliable system of
manually recording the results. Use of an automatic
urine reagent strip reader would be preferable to
visual reading.
months
Performance assessment: some slight
overestimation at lower albumin concentrations
potentially giving rise to some false positive cases of
microalbuminuria
Overall ease of use: rated satisfactory by the
ergonomic assessment and good by the users
Training quality: no training was offered by the
supplier but IFU were supplied with the product
Potential use: in a clinic or on a ward
Acknowledgements
62
We should like to thank the following for their contribution to this buyers guide.
Janet Anderson, Ergonomist, University of Surrey
Alistair Ashworth, Director, Econo-med
Steve Carey, NPT Team Leader, Siemens Healthcare Diagnostics Ltd
Paul Henriksen, UK Sales manager, Axis Shield UK
Anneliese Holland, Country manager UK, HemoCue Ltd
Dr David Lovell, Statistician, University of Surrey
Wendy Reynolds, Account manager, Bio-Rad Laboratories Ltd
Sue Ross, Marketing executive Diabetes care, Roche Diagnostics Ltd
Catherine Spurgeon, Product manager - urinalysis, Siemens Healthcare Diagnostics
Ltd
Jon Strotton, Northern European Manager Diabetes and Haemoglobinopathies, BioRad Laboratories Ltd
Talat Syed, Director, Chirus Ltd
Bharat Vadukul, Managing Director, BHR Pharmaceuticals Ltd
Lena Wahlhed, Global product manager urine albumin, HemoCue AB
Sue Younghusband, Marketing director, Axis Shield UK
The diabetic clinic nursing team, Cedar Centre, Royal Surrey County Hospital
The point of care support team and clinical laboratory staff, Partnership Pathology
Plus, Royal Surrey County and Frimley Park Hospitals
Respondents to our survey questionnaire
CEP08057: June 2009
Glossary
63
ACR
albumin:creatinine ratio (mg albumin/mmol creatinine)
Average bias
represents the mean difference between the POC

method and the laboratory method used as a reference
method. It is an indication of accuracy.
Confidence interval
gives a measure of the range of result deviations from

the line of agreement of the graph
FSC
Forest Stewardship Council
Glycaemic
relating to blood glucose
Haemoglobinopathy
a genetic defect that results in an abnormal structure of

one of the globin chains of the haemoglobin molecule
Levey Jennings plot
a graph of quality control data showing how well the

analytical test is performing
NGSP
National Glycohemoglobin Standardization Program.

Its purpose is to standardise glycated haemoglobin test
results so that all method results are comparable to
those reported in the DCCT trial.
Non-quantitative
referring to semi-quantitative and qualitative methods
Recyclate
recycled material that is used to form new products
Reportable range
the range of concentrations across which the device

can provide an accurate result
Semi-quantitative
providing an approximation of the quantity or amount of

a substance; between quantitative and qualitative
Sensitivity (in this

report)
percentage of microalbuminuria positive tests by

reference method which are positive by POCT
Specificity (in this

report)
percentage of microalbuminuria negative tests by

reference method which are negative by POCT
Virgin materials
materials that have not been used in production before

i.e. not recyclate
CEP08057: June 2009
References
64
1. Report of the Review of NHS Pathology Services in England. Chaired by Lord

Carter of Coles. Department of Health 2006.
2. Guidelines for the safe and effective management and use of Point of Care
Testing Approved by the Academy of Medical Laboratory Science, Association
of Clinical Biochemists in Ireland, Irish Medicines Board and RCPI Faculty of
Pathology November 28, 2007.
3. Report of the Second Phase of the Review of NHS Pathology Services in
England. Chaired by Lord Carter of Coles. Department of Health 2008.
4. Diabetes in the UK 2004. A report from Diabetes UK October 2004. Available
from http://www.library.nhs.uk/DIABETES/ViewResource.aspx?resID=82430
5. The Diabetes Control and Complications Trial (DCCT) . Links to documents
available at http://www.bsc.gwu.edu/bsc/studies/dcct.html
6. The Diabetes Control and Complications Trial and Follow-up Study.
http://diabetes.niddk.nih.gov/dm/pubs/control
7. American Diabetes Association. Implication of the United Kingdom
Prospective Diabetes Study. Diabetes Care 2002; 25: S28-S32
8. Kanavos P, Ostergren J, Weber M. High blood pressure and health policy.
2007 ISBN-10 1-932646-43
9. National Institute for Clinical Excellence Inherited Clinical Guideline 66 Type 2
diabetes. The management of type 2 diabetes. 2006.
10. Department of Health. National Service Framework for Diabetes: Standards.
2001
11. Department of Health. The National Service Framework for Renal Services.
Part Two: Chronic kidney disease, acute renal failure and end of life care.
2005.
12. National Institute for Clinical Excellence Clinical Guideline15 Type 1 diabetes:
diagnosis and management of Type1 diabetes in children, young people and
adults. 2004
CEP08057: June 2009
References
65
13. National Institute for Clinical Excellence Clinical Guideline G. Guideline for
type 2 diabetes, management of blood glucose. 2002.
14. National Institute for Clinical Excellence Clinical Guideline 73 Chronic Kidney
Disease Early identification and management in adults in primary and
secondary care. 2008.
15. Crowe E, Halpin D, Stevens P on behalf of the Guideline Development Group.
Early identification and management of chronic kidney disease: summary of
NICE guidance. BMJ 2008; 337: 812-815.
16. Proteinuria: detection and quantitation in adults using ACR information for
GPs. http//www.dh.gov.uk/pubilcations
17. Proteinuria: detection and quantitation in adults using ACR information for
laboratories. http//www.dh.gov.uk/publications
18. Sacks DB, Arnold M, Bakris GL, Bruns DE, Horvath AR, Kirkman MS, et al.
The National Academy of Clinical Biochemistry Laboratory Medicine Practice
Guidelines: Guidelines and recommendations for laboratory analysis in the
diagnosis and management of diabetes mellitus: Update. Draft guidelines
Version 1107, 2007. Accessed at the AACC website November 12th 2008.
http://www.aacc.org/Pages/default.aspx
19. John WG, Mosca A, Weykamp C, Goodall I. HbA1c standardisation: History,
Science and Politics. Cin Biochem Rev 2007; 28:163-168.
20. National Glycohemoglobin Standardization Program. http://www.ngsp.org
21. Manley SE, Round RA, Smith JM. Calibration of HbA1c and its measurement
in the presence of variant haemoglobins: report on questionnaire to
manuafacturers. Annals of Clinical Biochemistry 2006; 43:135-145.
22. Sickle cell and Thalassaemia Handbook for Laboratories. 2006. Available from
http://www.kcl-phs.org.uk/haemscreening/Documents/LabHandbook2006.pdf
23. National Institute for Clinical Excellence Inherited Clinical Guideline F
Management of type2 diabetes, renal disease prevention and early
management. 2006.
CEP08057: June 2009
References
66
24. Clinical and Laboratory Standards Institute. Point-of-Care In Vitro Diagnostic

(IVD) Testing; Approved Guideline. 2nd Edition 2006. POCT4-A2 Volume 26:
No 30
25. Device Bulletin Management and use of IVD Point of Care Test Devices.
MDA DB2002(03). March 2002. ISBN 1 84182 533 6
26. Point of Care Testing Top 10 Tips. MHRA 2004.
27. Point-of-care testing (POCT) Requirements for quality and competence. ISO
22870: 2006(E)
28. Aarsand AK, Alter D, Frost SJ, Kaplanis B, Klovning A, Price CP et al.
Diagnosis and Management of Diabetes Mellitus. Chapter 6 in Evidence
based practice of Point of Care Testing, National Academy of Clinical
Biochemistry, Laboratory Medicine Guidelines. AACC 2006.
29. Clarke W, Frost SJ, Kraus E, Ferris M, Jaar B, Wu J, et al. Renal function
testing. Chapter 12 in Evidence based practice of Point of Care Testing,
National Academy of Clinical Biochemistry, Laboratory Medicine Guidelines.
AACC 2006.
30. Clinical and Laboratory Standards Institute. Implementation guide of POCT01
for Health Care Providers. Approved Guideline 2008. POCT02-A Volume 28
No 18
31. Cagliero E, Levina E, Nathan D. Immediate feedback of HbA1c levels
improves glycaemic control in type1 and insulin-treated type 2 diabetic
patients. Diabetes Care 1999; 22: (11) 1785-1789.
32. Yokoyama K, Cryar A, Griffin K, Godley P, Woodward B. Cost-effectiveness
of a multidisciplinary diabetes care clinic. Drug Benefit Trends 2002;
14(Supplement D): 36-41, 43-44.
33. Grieve R, Beech R, Vincent J, Mazurkewicz J. Near patient testing in diabetes
clinics: appraising the costs and outcomes. Health Technology Assessment
1999; 3: No 15
34. Robinson P. Personal communication on local scheme for point of care
testing for microalbuminuria. 2008.
CEP08057: June 2009
References
67
35. Kiberd B, Jindal K. Screening to prevent renal failure in insulin dependent

diabetic patients: an economic evaluation. British Medical Journal 1995;
311:1595-1599.
36. Davidson E, Croal B. Introduction of an Albumin-to-Creatinine ratio point of
care device: analytic, clinical and cost effectiveness aspects. Point of Care:
The Journal of Near-Patient Testing and Technology 2003; 2(2): 89-95.
37. National Institute for Clinical Excellence Clinical Guideline 73 Chronic Kidney
Disease Costing report. Implementing NICE guidance.
38. http://nww.pasa.nhs.uk/PASAWeb/Guidance/TOPPM/LandingPage.htm (NHS
intranet only)
39. http://www.ogc.gov.uk/procurement_policy_and_application_of_eu_rules_eu_
procurement_thresholds_.asp
40. UK Government Strategy for Sustainable Development; Securing the Future
http://www.sustainable-development.gov.uk/publications/uk-strategy/index.htm
41. Health and Safety Executive. Reducing noise at work. Guidance on the noise
at work regulations 1989. ISBN 0 7176 1511 1.
42. EC Directive on Waste Electrical and Electronic Equipment
http://www.berr.gov.uk/files/file35992.pdf
43. User demonstration of Performance for Precision and Accuracy: Approved
guideline. CLSI EP15-A 21: No 25 2001.
44. Guy M, Newall R, Borzomator J, Kalra PA, Price CP. Diagnostic accuracy of
the urinary albumin: creatinine ratio determined by the Clinitek Microalbumin
and DCA 2000+ for the rule-out of albuminuria in chronic kidney disease. Clin
Chim Acta 2008; doi:10.1016/j.cca.2008.09.006
45. http://www.pasa.nhs.uk/pasaweb/productsandservices/leasing
46. http://www.ogc.gov.uk/stdtoolkit/reference/documentation/p13_buscase.html
47. http://nww.pasa.nhs.uk/PASAWeb/Guidance/OPPM/LandingPage.htm (NHS
intranet only)
CEP08057: June 2009
References
68
48. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPro
curement/DH_4070620
49. http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPro
curement/DH_4109316
CEP08057: June 2009
Appendix 1: Supplier contact details
69
Supplier
Devices
Axis-Shield UK
Ouse Road
Bicton Industrial Park
Kimbolton
Cambridgeshire
PE28 0LP
Tel: 01480 862100
Email:
Afinion
NycoCard
www.axis-shielduk.com
Bio-Rad Laboratories Ltd

Bio-Rad House
Maylands Avenue
Hemel Hempstead
Herts HP2 7TD
Tel: 0800 181134
Email: techsupport.uk@bio-rad.com
in2it
www.bio-rad.com
BHR Pharmaceuticals Ltd

41 Centenary Business Centre
Hammond Close
Attleborough Fields
Nuneaton
Warwickshire
CV11 6RY
Tel: 024 7635 3742
Email: info@bhr.co.uk
www.bhr.co.uk
CEP08057: June 2009
ImmunoDip
70
Supplier
Devices
Chirus Limited
Park House
15-23 Greenhill Crescent
Watford Business Park
Watford
Hertfordshire WD18 8PH
United Kingdom
Tel: 01923 212744
Email: info@chirus.com
www.chirus.com
A1cNow+
econo-med
Trafalgar House
Station Road
Long Sutton
Lincs
PE12 9BR
Tel: 01406 364242
Email:info@econo-med.com
Uritest 13G
www.uritest.co.uk
HemoCue Limited
Viking Court
31 Princess Road
Dronfield
Derbyshire
S18 2LX
Tel: 01246 292955
Email:
customercare@prospectdiagnostics.co.uk
www.hemocue.com
CEP08057: June 2009
HemoCue
71
Supplier
Devices
Roche Diagnostics Ltd

Charles Avenue
Burgess Hill
West Sussex
RH15 9RY
Tel: Freephone 0808 100 9998
Email: burgesshill.pm@roche.com
www.roche-diagnostics.co.uk
Micral-Test
Siemens Healthcare Diagnostics Ltd

Newton House
Sir William Siemens Square
Frimley
Camberley
Surrey GU16 8QD
Tel 01276 696000
Email: info.cc.uk@siemens.com
DCA Vantage
www.siemens.co.uk
CEP08057: June 2009
Clinitek Status
Microalbustix
Appendix 2: EU procurement procedure
72
EU procurement procedure
Lease options
National frameworks are in place for operating leases to help the NHS procure
leases more cost efficiently and effectively. The framework came into place on 1st
April 2007 and runs for two years. Further details are available from the PASA
website [45].
EU procedures
The Public Sector Directive (2004/18/EC) has been transposed into UK law via the
following statutory instruments:
the Public Contracts Regulations SI 2006 No.5 (the regulations)
the Utilities Contracts Regulations SI 2006 No. 6 (not relevant to this guide).
The regulations apply to contracts worth more than 90,319 (from January 1st 2008)
[36] over their whole life, and specify the procedures to be followed for public sector
contracting, including adherence to strict timetables, requirements for advertising,
invitation to tender and the award of contract. Organisations undertaking a
procurement exercise covered by the regulations must give all suppliers an equal
opportunity to express an interest in tendering for the contract by placing a contract
notice in the Official Journal of the European Union (OJEU).
At all stages of the procurement process, the purchaser must be demonstrably fair,
as any decision made can be challenged by the unsuccessful suppliers.
Establishing a procurement strategy
To achieve a successful outcome, decisions need to be made on:
whether an existing contract/agreement can be used

the need to consider sustainable development issues
whether EU directives apply
the type and form of contract
sourcing potential suppliers
duration of contract and opportunity to review/extend
payment schedules
how to minimise any risks with the chosen strategy, including supplier appraisal
and evaluation/clarification of suppliers bids.
Preparing a business case

A business case should be drafted and approved before conducting any procurement
exercise. Further guidance on preparing business cases is available from the Office
CEP08057: June 2009
Appendix 2: EU procurement procedure
73
of Government Commerce [46] and an illustrative example is provided in the NHS

PASA Operational Purchasing Procedures Manual, Procedure 1-01 [47].
The EU tendering exercise
EU procurements usually take between 4 and 6 months to complete. This needs to
be taken into account in the planning stages. The length of the exercise depends on
the chosen procedure (open or restricted). Further information is available from the
Department of Health [48].
The procurement panel
A multidisciplinary team should be selected to guide the purchase. Representatives
from clinical, user, technical, estates and financial areas should be considered.
Identifying potential suppliers
Criteria for supplier selection must be established. A supplier pre-qualification
questionnaire may be employed as an initial screen to exclude unsuitable suppliers
which asks for details such as skills and experience of the service engineers.
Evaluation criteria
Performance specifications should be derived from local operational requirements,
and agreed by the procurement panel. They will form the basis for assessing the
adequacy of suppliers technical specifications, provided in response to the technical
specification questionnaire.
It is important to have agreed on the performance specifications of the product as
they will be used in the adjudication against company specifications.
Requests for features which are supplier-specific are not permitted under the
regulations. Very specific features which are not supported by operational
requirements are also not allowed.
Award of contract
Following award of the contract to the successful supplier; unsuccessful suppliers
may need to be debriefed. This is at the suppliers request.
Buyers must be aware of the Alcatel procedure (see the Trust Operational
Purchasing Procedures Manual [38], Procedure No.T-08, section 6 - Mandatory
Standstill Period).
For more information on procurement please refer to the Department of Health
Website [49].
CEP08057: June 2009
Appendix 3: Technical evaluation data
74
Technical evaluation data

Table 24. HbA1c devices: technical performance
Device
A1cNow+
Afinion
DCA Vantage
in2it
NycoCard
1.02
(Tosoh 2.2 Plus HPLC)
0.96
(affinity HPLC)
0.92
(IE HPLC by Tosoh G7,
BioRad Variant II and
BioRad D10)
0.88-0.90
(IE HPLC)
No information
3.0 at 6, 4.0 at 9% HbA1c
1.1 at 5.6 and 10%

HbA1c
2.6 at 5.3, 3.2 at 11.6%

HbA1c
2.9 at 5, 3.1 at 9, 2.8

at 12% HbA1c
<5 across whole

measuring range
0.87
(0.81 to 0.92)
1.04
(1.01 to 1.07)
1.19
(1.13 to 1.25)
1.04
(0.99 to 1.09)
1.15
(1.09 to 1.21)
-0.1 to -1.8
-0.6 to +0.6
-0.1 to 1.8
-0.5 to 1.2
-0.1 to 2.1
No average bias
-0.23
(up to 10% HbA1c)
0.13
(up to 8.5% HbA1c)
0.08
(full range)
No average bias
Increasing negative bias

with concentration.
Rise in bias and

scatter above 10%
HbA1c
Sudden rise in bias

above 9% HbA1c
Increase in scatter at
higher concentration
Increasing positive
bias with
concentration
Manufacturers claims
Accuracy slope
(reference method)
Reproducibility
(total CV%)
Evaluation results
Accuracy slope
(95% CI)
Bias range
Average bias (% HbA1c)
(analyte range)
Comment
CEP08057: June 2009
75
Table 25. Urine albumin quantitative devices: technical performance - albumin

Device
Afinion
DCA Vantage
HemoCue
NycoCard
0.93
(immunoassay by Roche
MODULAR P)
1.02
(immunoassay by
ARCHITECT, ADVIA,
Olympus)
0.97
(immunoassay by Beckman
Coulter CX5)
No information
5.5 at 12, 4.8 at 55, 5.0 at 175

mg/L
5.6 at 34, 4.5 at 226 mg/L
4.3 at 27 mg/L and 9.2 at 79

mg/L
5-8 usual
0.87
(0.83 to 0.90)
1.06
(1.02 to 1.09)
0.92
(0.87 to 0.97)
0.92
(0.89 to 0.96)
-15.9 to 9.6
-8.7 to 36
-28.0 to 8.4
-13.1 to 6.9
No average bias
No average bias
-4.4 (up to 148 mg/L)
No average bias
Positive bias up to
approximately 70 mg/L
becoming negative at higher
concentrations.
Positive bias up to
approximately 40 mg/L.
Variable at higher
concentrations.
Marked scatter. One sample

increased bias range, from 15 to -28.
Positive bias up tp
approximately 40 mg/L
becoming negative at
higher concentrations.
Accuracy slope
(reference method)
Reproducibility
(total CV%)
Evaluation results
Accuracy slope
(95% CI)
Bias range
Average bias (mg/L)
(analyte range)
Comment
CEP08057: June 2009
76
Table 26. Urine albumin quantitative devices: technical performance creatinine and ACR
Device
Afinion
Creatinine
DCA Vantage
Creatinine
Afinion
ACR
DCA Vantage
ACR
0.97
(Roche MODULAR P)
0.95
(Jaffe based by
ARCHITECT, ADVIA,
Olympus )
1.01
(Roche MODULAR P)
1.06
(ARCHITECT, ADVIA,
Olympus)
3.8 at 5, 2.7 at 14, 3.0 at 31

mmol/L
3.6 at 8.9, 4.3 at 34.7 mmol/L
4.8 at 0.4, 4.6 at 4, 6.0 at 39

mg/mmol
4.7 at 3.8, 2.3 at 6.5

mg/mmol
0.92
(0.87 to 0.97)
1.01
(0.95 to 1.08)
1.08
(1.04 to 1.11)
1.01
(1.00 to 1.03)
-2.7 to 0.8
-1.5 to 2.6
-1.1 to 5.4
-2.5 to 3.4
-0.15
(up to 17 mmol/L)
0.35
(up to 11 mmol/L)
0.52
(up to 20 mg/mmol)
No average bias
Single sample at > 17

mmol/L had greater
negative bias.
Bias much more variable

above 11 mmol/L, scatter
marked.
Marked scatter, majority

positive bias. Greater
positive bias above 20
mg/mmol.
Positive bias up to about 4

mg/mmol. Bias variable
above this, scatter marked.
Accuracy slope
(reference method)
Reproducibility
(total CV%)
Evaluation results
Accuracy slope
(95% CI)
Bias range
Average bias (mmol/L or mg/mmol)
(analyte range)
Comment
CEP08057: June 2009
77
Table 27. Manufacturers claimed performance for urine albumin non-quantitative measurement devices (link to glossary)
Device
(reference method)
Clinitek Status
(Immunoassay)
Microalbustix
(immunoassay)
Uritest 13G
ImmunoDip
(Quest Hitachi 717)
Micral-Test
(immunoassay)
Sensitivity (%) - albumin
83
90
No data
100
92
Sensitivity (%) - ACR
83
84
No data
N/A
N/A
Specificity (%) - albumin
87
88
No data
71
94
Specificity (%) - ACR
86
91
No data
N/A
N/A
CEP08057: June 2009
78
Figure 5. HbA1c: POCT method comparison to reference method

14
y=x
13
Afinion
DCA Vantage
in2it
A1cNow+
NycoCard
12
11
10
9
8
7
6
5
4
4
10
12
14
Menarini 8160 % HbA1c
Figure 6. Urine albumin: POCT method comparison to reference method

300
y=x
Afinion
DCA Vantage
HemoCue
NycoCard
250
200
150
100
50
0
0
50
100
150
200
Siemens ADVIA 2400 albumin mg/L
CEP08057: June 2009
250
300
79
Figure 7. Urine creatinine: POCT method comparison to reference method

18
y=x
16
Afinion
DCA Vantage
14
12
10
0
0
10
12
14
16
18
Siemens ADVIA 2400 creatinine mmol/L
Figure 8. ACR: POCT method comparison to reference method

45
y=x
Afinion
DCA Vantage
40
35
30
25
20
15
10
0
0
10
15
20
25
30
35
Siemens ADVIA 2400 ACR mg/mmol
CEP08057: June 2009
40
45
80
Figure 9. Urine albumin measurement: POCT method comparison to reference method

a. ImmunoDip and Micral-Test
Micral-Test
ImmunoDip
100
50
20
pos
neg
0
50
100
150
200
250
300
b. Clinitek Status and Microalbustix

150
Clinitek Status
Microalbustix
80
30
10
0
50
100
150
200
Siemens ADVIA 2400 albumin 2400
CEP08057: June 2009
250
300
81
Figure 10. Uritest 13G: urine measurements comparison to reference method

a. urine albumin
Uritest 13G
100
neg
neg
50
100
150
200
250
300
b. urine creatinine
Uritest 13G
26.4
17.6
One reading to this colour block but no reference method result
8.8
4.4
0.9
0
10
12
14
CEP08057: June 2009
16
18
20
82
Figure 11. Urine creatine and ACR: POCT method comparison to reference method
a. urine creatinine
26.5
Clinitek Status
Microalbustix
17.7
8.8
4.4
0.9
0
10
15
20
b. urine ACR
Clinitek Status
Microalbustix
>33.9/
high
abnormal
3.4-33.9/
abnormal
<3.4/
normal
0.1
2.5 3.5
10
Siemens ADVIA 2400 ACR mg/mmol
CEP08057: June 2009
100
1000
83
Table 28. HbA1c methods: comparison at normal Type 1 diabetes cutoff 7.5% HbA1c
Sample number
10
11
12
13
14
15
16
17
18
19
20
21
% HbA1C
Menarini HA 8160
5.1
5.2
5.4
5.7
6.1
6.6
6.8
7.0
7.4
7.9
8.1
8.4
9.0
9.5
9.7
10.2
10.4
10.4
12.1
12.3
17.2
A1cNow+
4.85
4.8
5.05
5.35
5.55
6.1
6.55
6.1
6.4
7.2
7.35
7.0
8.2
8.7
8.9
9.4
8.64
9.05
11.25
11.0
>14.0
Afinion
5.0
5.05
5.35
5.55
5.8
6.2
6.45
6.75
7.25
7.5
7.6
8.1
8.95
9.25
9.65
10.4
10.2
10.6
12.55
12.0
>15.0
DCA Vantage
5.2
5.2
5.5
5.85
6.25
6.75
6.95
7.1
7.6
7.95
8.4
8.5
9.45
9.75
10.55
11.05
11.5
12.1
>14.0
>14.0
>14.0
in2it
4.95
5.1
5.7
5.65
6.05
6.65
6.5
7.2
7.6
8.2
7.65
8.25
9.15
9.75
10.1
10.45
10.25
10.8
12.85
12.0
>13.0
NycoCard
5.75
5.2
6.1
6.1
6.8
6.9
7.55
7.5
8.1
8.6
9.5
9.1
10.4
11.15
10.75
11.5
11.9
12.15
13.4
13.15
>15.0
The results for each analyte are ordered according to the laboratory result therefore the sample numbers are not always in consecutive order. The clinically
normal results, below the cutoff, are shown as coloured blocks in tables 28-32; HbA1c - pink, albumin - orange and ACR blue. The dark green line marks the
cutoff according to the laboratory method.
CEP08057: June 2009
84
Table 29. Quantitative urine albumin methods: comparison at normal cutoff 20 mg/L
1
Sample number
10
11
mg/L
ADVIA 2400
2.9
4.6
5.7
7.6
9.1
13.1
19.2
20.9
21.1
21.6
23.2
Afinion
< 5.0
7.45
8.9
13.1
17.3
22.25
24.6
26.85
25.05
29.3
28.2
DCA Vantage
7.6
9.4
12.6
15.0
18.95
24.35
26.35
28.05
28.75
25.2
HemoCue
6.0
< 5.0
5.5
6.0
11.0
19.5
8.5
22.5
28.0
19.0
NycoCard
< 5.0
< 5.0
7.0
10
14.0
19.5
20.0
25.0
25.5
26.0
24.5
10
11
* No mean as one result < or >
Table 30. Non-quantitative urine albumin methods: comparison at normal cutoff 20 mg/L
Sample
6
mg/L
ADVIA 2400
2.9
4.6
5.7
7.6
9.1
13.1
19.2
20.9
21.1
21.6
23.2
Clinitek Status
10
10
10
10
10
30
30
30
30
Microalbustix
10
10
10
10
30
30
30
30
30
30
30
Uritest 13 G
> 100
> 100
> 100
> 100
> 100
> 100
> 100
> 100
> 100
> 100
> 100
ImmunoDip
Neg
Neg
Neg
Micral-Test
Neg
Neg
Neg
20
* No mean because duplicates not the same

Negative cutoff is 18 mg/L
CEP08057: June 2009
Neg
Neg
Pos
Neg
Pos
20
20
20
20
*
20
85
Table 31. Quantitative measurements of ACR: comparison of at normal female cutoff 3.5 mg/mmol
Sample number
11
12
13
mg/mmol
ADVIA 2400
0.4
0.3
0.5
0.6
0.9
1.5
1.7
1.7
2.2
3.8
4.9
Afinion
0.6
0.8
0.95
1.85
1.95
2.1
1.65
2.85
4.2
5.45
DCA Vantage
0.45
0.75
0.8
1.4
1.7
1.95
2.25
2.3
3.9
4.5
* No mean as one result < or >

No result Afinion not give ACR result if contributing results < or >
Table 32. Non-quantitative measurements of ACR: comparison of at normal female cutoff of 3.5 mg/mmol
Sample number
11
12
13
mg/mmol
0.4
0.3
0.5
0.6
0.9
1.5
1.7
1.7
2.2
Clinitek Status
< 3.4
< 3.4
< 3.4
< 3.4
< 3.4
< 3.4
< 3.4
< 3.4
< 3.4
3.4-33.9
< 3.4
Clinitek Status comment
Normal
Normal
Normal
Normal
Normal
Normal
Normal
Normal
Normal
Abnormal
Normal
Microalbustix comment
Normal
Normal
Normal
Normal
Abnormal
Normal
Normal
Abnormal
Normal
Abnormal
Normal
ADVIA 2400
CEP08057: June 2009
3.8
4.9
Author and report information

Buyers guide:
Point of Care devices for the
measurement of HbA1c and low
concentration albumin in urine
Sheena Pearson, Susan Lamph, Wendy
Bennitt, Stephen P Halloran
Guildford Medical Device Evaluation

Centre
Postgraduate Medical School
Daphne Jackson Road
Manor Park
University of Surrey
Guildford
Surrey GU2 7WG
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About CEP
Crown Copyright 2009
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
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the uptake of useful, safe and
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We are here to help you make
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agreed protocols.
CEP08057: June 2009
86

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Buyers guide

Point of care devices for the

Author and report information.................................................................86

CEP08057: June 2009

a patients life is under threat

CEP08057: June 2009

CEP08057: June 2009

level 1 certification 95% confidence intervals (CI) of differences must be

Devices for the measurement of HbA1c

Calibration and reportable ranges

Devices for the measurement of urine albumin and ACR

Sources of error in POCT

CEP08057: June 2009

Quality control and quality assurance

CEP08057: June 2009

POC testing by non-laboratory healthcare professionals requires well organised

Space requirements, accessories, consumables, storage and

Service provision, workflow and impact on patient pathways

CEP08057: June 2009

Staff requirements, training and instructions

CEP08057: June 2009

Urine reagent strip good features:

an automated reader is required to remove all subjective elements of reading

numerous operator dependent steps

Servicing and maintenance

Software and IT connectivity

selection of results by a variety of identifiers e.g. date, patient, lot number

remote checking of QC and calibration

CEP08057: June 2009

Published evidence on cost-effectiveness

Potential costs and benefits

purchase of equipment with the necessary features and software

reduced travel if the patient is seen in primary care

Value added features

CEP08057: June 2009

Purchasing considerations for local use

CEP08057: June 2009

Some manufacturers claims to provide a connectivity system may be misleading.

is subsequently decontaminated such that it no longer poses an infection risk, it is

CEP08057: June 2009

stakeholders following consultation on the best information to include

CEP08057: June 2009

Table 1. HbA1c quantitative measurement comparative table (page 1 of 4)

Calibration traceable to:

Sample volume (L)

Analysis time (min)

HbF, HbS, HbC and

HbF >10%, HbS, HbC,

Reportable range HbA1c (%)

Quality control material supplied

CEP08057: June 2009

Error codes, explanation

Error code + brief

Consumable storage long-term

Consumable storage at room

Waste collection and disposal

Used cartridge liquid

Used disc and pipette

Locked while analysing

Printer and use of labels

1 until next test

Other analytes measured

Analyser result storage (Patient +