buyers guide urine monitors for diabetes

8/10/2019 Buyers Guide Urine Monitors for Diabetes

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Buyers guide

Point of care devices for themeasurement of HbA1cand lowconcentration albumin in urine

CEP08057

June 2009


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Contents 2

CEP08057: June 2009

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


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Introduction 3

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Devices that provide analyses at the point of care are now commonplace. Obtainingprompt results can increase clinical effectiveness and can contribute to improvedoutcomes for patients, but results must be accurate and reliable. The improvedreliability and range of point of care testing (POCT) devices has led to their increaseduse in community clinics, general practitioner (GP) surgeries and the homeenvironment. There is a growing demand for POCT as patients exercise choice andhave a greater range of healthcare facilities available to them [1]. Clinicaleffectiveness 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 robustmanagement structure, and accreditation, audit and clinical governance should beintegrated with that of the laboratory [3]. Information technology (IT) links with locallaboratories play an important part in facilitating appropriate transfer and storage ofPOCT results, which currently are not always added to the patients notes.

The 2006 report recognised that by locating test equipment near to the patient, testresults can be made available more rapidly, and decisions on appropriate treatmenttaken 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 savingselsewhere in the patient pathway, through earlier treatment, reduction in the numberof clinic visits required, shortened in-patient stays etc[1].

ScopeThis buyers guide describes POCT devices for haemoglobin A1c(HbA1c) and lowconcentration albumin in urine that are currently available in the UK. Comparativeinformation is presented for quantitative measurement of HbA1cand 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 currentusers (tables 5-8)and a limited technical evaluation (tables 24-32 andfigures 5-11).Technical, operational and economic considerations and information on purchasingare also presented.


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Introduction 4

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Background

The incidence of both type 1 and type 2 diabetes is rising in the UK [4]. It has beenshown in the Diabetes Control and Complications Trial (DCCT) and the UKProspective Diabetes Study (UKDPS) that good control of blood sugarconcentrations in both types of diabetes reduces the risk of microvascular diseasesuch as renal failure and reduces the long term risk of macrovascular disease suchas coronary heart disease [5-7]. HbA1cconcentration is an indicator of the level ofblood glucose control over the past 3 months, weighted towards the control of thelast 30 days. HbA1cmeasurements therefore provide a good means of monitoringdiabetic glycaemic control and response to treatment. It is widely accepted that the

risks of developing micro- or macrovascular disease are minimised by maintainingHbA1cconcentrations as low as possible without increasing hypoglycaemic episodes.

Patients with diabetes and those suffering from hypertension are at risk of developingrenal disease. Early detection of renal disease permits prompt treatment and betterpatient outcomes [7, 8]. Urine albumin measurements can be used to screen for thepresence of elevated urine albumin concentrations (albuminuria) and to monitor theprogression of kidney disease and response to treatment.

This guide covers products for point of care measurement of HbA1cand low

concentration albumin in urine on the UK market in June 2008. The products aredescribed in detail in the market review (page 23).

This guide includes four urine albumin analysers, three of which use single-usedisposable cartridges or cuvettes, and five non-quantitative albumin urine reagentstrips. Two of the analysers also measure creatinine allowing the calculation of thealbumin:creatinine ratio (ACR) as recommended in NICE guidance [9]. Three of theurine reagent strips measure creatinine as well as albumin. One strip is used with anelectronic reader which removes subjective visual reading and provides accuratelytimed reading and recording of results. Three of the analysers offer HbA1cand urinealbumin measurement. In addition the guide includes two analysers which onlymeasure HbA1c.

National guidance

National service frameworks

The National Service Framework for Diabetes [10]recommends that all laboratoriesmeasuring HbA1cshould participate in an external quality assessment (EQA) schemefor HbA1cand should use a method of proven accuracy and reproducibility. POCTanalysers should also be subject to EQA.

The National Service Framework for Renal Services [11]indicates that diabetes andhypertension are the greatest risk factors for the development of chronic kidney


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Introduction 5

CEP08057: June 2009

disease (CKD). Early stage CKD can be detected by testing urine for lowconcentration albumin in at risk populations. Early detection will permit timelyintervention before dialysis or transplantation become necessary.

NICE

Guidance from the National Institute for Health and Clinical Excellence (NICE) statesthat, provided there is no disabling hypoglycaemia, the target HbA1cconcentration forchildren, young people and adults with type 1 diabetes is 7.5% HbA1c [12]. For adultswith increased risk of developing complications of diabetes the target is 6.5% HbA1c.HbA1cshould be measured by a DCCT harmonized method 2-4 times a year as

required. If the HbA1cconcentration is consistently >9.5% additional support shouldbe offered.

Lowering HbA1clevels in type 2 diabetes reduces tissue damage [13]. Patients withtype 2 diabetes should be encouraged to keep HbA1cconcentration to 6.5% or belowif it is safe and appropriate for that individual, to improve their longer term quality oflife. Individual targets may be set above this following agreement with the individualshealth care team.

It is inappropriate to monitor glycaemic control by measurement of HbA1cin the

presence of haemoglobinopathies or increased red blood cell turnover [9,12].

Microalbuminuria should be monitored annually to screen for signs of complicationsof type 1 diabetes from the age of 12 [12]. NICE defines microalbuminuria in patientswith diabetes as urine albumin concentration greater than or equal to 20 mg/L or anACR greater than or equal to 2.5 mg/mmol (men) or 3.5 mg/mmol (women), andrecommends that urinary ACR concentration is measured annually in patients withtype 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 ofthe NICE guidance [15]highlights that reagent strips for detecting albumin in urineare not quantitative. Quantitative ACR measurement is more sensitive for earlydetection of CKD than the protein:creatinine ratio (PCR). Those patients withoutdiabetes should be referred for specialist assessment when the ACR is >30mg/mmol.

The Department of Health has produced leaflets for GPs and laboratories highlightingthe advice on the detection and quantitation of proteinuria given in the NICEguidance on chronic kidney disease [16, 17, 14].


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Technical considerations 6

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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 oferroneous results. POCT results should ideally match those produced by thelaboratory so that a patients progress can be consistently monitored whichevertesting method is employed.

Technical guidelines

Calibration of laboratory and POCT methods to the same standard material ensurescomparability of results, facilitating interpretation. Analysers are usually calibrated bythe manufacturers using a secondary reference material which has itself beencalibrated against a primary reference material.

HbA1c

All POCT and laboratory methods should be certified by the NationalGlycohemoglobin Standardization Program (NGSP) and traceable to DCCT. Inter-assay imprecision should be < 5%, preferably < 3%, and laboratories should beaware of potential interference by haemoglobin variants [18]. Method calibrationshould 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 NGSPsecondary reference laboratory method:

level 1 certification 95% confidence intervals (CI) of differences must bewithin 0.75% HbA1c

level 2 certification 95% confidence intervals (CI) of differences must bewithin 0.85% HbA1c.

Albumin

The analytical coefficient of variation (CV) of methods for the detection of

microalbuminuria should be 95% of patients with microalbuminuria. Positive results mustbe confirmed by an accredited laboratory [18].

Devices for the measurement of HbA1c

Sample

True point of care measurements require freshly collected samples which require nofurther processing. For these devices, whole blood capillary samples give optimumperformance, although some can also use venous blood samples. Heparin,ethylenediaminetetraacetic acid (EDTA) or fluoride oxalate are acceptableanticoagulants for most HbA1cmeasurement devices.


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Calibration and reportable rangesThe IFCC has established an international reference measurement system for HbA1cwhich should be used for calibrating all HbA1cmethods. In the UK it is recommendedthat HbA1cresults should be reported in both IFCC units (mmol/mol) and derivedNGSP units (%), synonymous with DCCT, from June 2009 onwards. Conversionbetween the IFCC and NGSP units is achieved by the IFCC-NGSP master equation[19]. The reportable ranges of POCT devices must be suitable for monitoringglycaemic control in patients with diabetes and should extend from at least 4-14%HbA1c.

Analytical errors and interferencePOCT results must be reliable as operators may not be aware of potential sources oferror. Analysers should give error messages when an error in the analyticalprocedure has occurred, (whether due to the analyser or the operator), and shouldnot provide a numerical result in such circumstances.

However, the presence of interfering substances in the sample may produceerroneous results. Haemoglobin (Hb) variants, including fetal haemoglobin (HbF), arethe most significant source of interference and they can be present in glycated andnon-glycated forms. Their presence is detectable by high performance liquidchromatography (HPLC) methods but not by current POCT methods. Therefore allpatients to be monitored using a POCT device should have an initial samplemeasured by an HPLC method to check for the presence of haemoglobin variants.

Analysers using methodology based on boronate affinity chromatography are notsusceptible to interference by variant haemoglobins but those based onimmunological techniques will have variable susceptibility depending on the specificantibody used [21]. The prevalence of haemoglobin variants is raised in some ethnicgroups. The antenatal and newborn screening programmes for sickle cell diseaseand thalassaemias have raised awareness of the prevalence of haemoglobin variants[22].

HbA1cconcentrations are disproportionately low in patients with increased red bloodcell turnover or anaemia, and should not be used to monitor glycaemic control insuch patients.

Devices for the measurement of urine albumin and ACR

Sample

A timed urine collection without added preservative is the recommended sample typefor urine albumin or ACR measurement. Screening using an untimed sample

(preferably early morning) is acceptable if an appropriate cutoff concentration is usedfor increased albumin excretion. The measurement of creatinine in addition to


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albumin improves the reliability of results from untimed urine collections [11,18]. Ifthe sample cannot be measured shortly after collection it should be refrigerated forno more than a week, but should not be frozen. A transparent container is required toaid dipping of the urine reagent strips.

Calibration and reportable ranges

The majority of the urine albumin POCT measurement devices are calibrated to theCertified Reference Material (CRM) 470 (also named ERM-DA470) from theReference Preparation for Proteins in Human Serum (RPPHS). The quantitativecreatinine methods are calibrated to Standard Reference Material (SRM) 914a from

the National Institute of Standards and Technology (NIST). The reportable ranges ofPOCT devices for albumin and creatinine should be suitable for screening purposesgiven the usual cutoff concentration for a normal urine albumin of 20 mg/L and anormal ACR of 2.5 or 3.5 mg/mmol for patients with diabetes and 30 mg/mmol forclinically significant proteinuria for those patients without diabetes [23,12, 16].Quantitative urine albumin measurements must be used for monitoring diseaseprogression and response to treatment.

Analytical methodology

Immunologically based tests for urine albumin are more specific than those involvinga chemically based colour change. Some methods for creatinine measurementinvolve use of an enzyme and a chemically based colour change and others onlyinvolve a chemically based colour change. Analysers which measure urine creatinineprovide the ACR results alongside results for albumin and creatinine.

Analytical errors and interference

Analysers measuring albumin, quantitatively or semi-quantitatively, should give errormessages when an error in the analytical procedure has occurred (whether due tothe 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 thedevice 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 thoseoccurring during the measurement. Pre-analytical errors for POCT include incorrectreagent or consumable storage and preparation for use, incorrect sample collectionand patient identification. Post-analytical errors include mis-recording of the result.


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CEP08057: June 2009

Quality control and quality assurance

At least two quality control (QC) materials with different values should be analysed asan independent measure of assay performance [18]. Material suitable for internal QCof this type of device is generally supplied or recommended by device suppliers.Some devices store QC results but none currently have data management systemswhich would allow the production of Levey Jennings plots to monitor long-termanalyser performance and therefore rely on downloading results to a computer toproduce these plots.

Participation in external quality assessment schemes (EQAS) enables the user tomonitor both the performance of the device and the operator. It is important that allthese POCT devices used for clinical analysis should participate in an accreditedEQAS [10]and several national schemes are available.


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Operational considerations 10

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POC testing by non-laboratory healthcare professionals requires well organisedsupport from laboratory staff to ensure the provision of accurate and reliable results.The organisational structure needed for this has been detailed by the CLSI, theMedicines and Healthcare products Regulatory Agency (MHRA) and in InternationalStandard ISO 22870 [24-27].

Space requirements, accessories, consumables, storage anddisposal

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. Caremust be taken to place analysers so that all operators can see the screen easily inambient lighting, avoiding glare.

Space for consumable storage needs to be considered. Most consumables for theseanalysers require long-term storage at 2-8C; some can be used directly from thefridge. Refrigerated space may be difficult to provide at POC. Some consumablescan be kept at room temperature for 1-3 months and therefore room temperaturestorage space will be required. Good stock control measures need to be adopted.

Infection control procedures should be adopted and the analyser placed in a suitablelocation to avoid contamination of other products.

Portability can be convenient for POCT devices and purpose-made carrying cases tohold the analyser and consumables can be very useful.

Battery operation can allow greater flexibility of location for use, however the mostcommon 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 printersavailable to use with them. The ability to print onto labels is an asset when securingresults into a patients notes. Printouts from thermal printers are subject to fadingmaking them unsuitable for storage. Photocopies of thermal printouts are acceptablebut this may not be convenient at the POC. Use of an inkjet printer would overcomethe problem of printout fading.

As IT links across the NHS improve, the goal of recording and transferring all resultsto an electronic patient record comes closer. The use of bar code readers to enterpatient details into the analyser is becoming more important and reduces the risk oftranscription errors at this point. The ability to record patient and operator IDs is also

important to reduce reporting errors due to misidentification of results. Electronicstorage and transfer of results are only of use if the patient ID is part of the stored


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result. The record of patient and operator IDs is also important to the point of care co-ordinator who requires them to be able to check an operators frequency of use anderror record to determine any need for retraining. Some point of care analysers offerthe possibility of locking out poorly performing operators. Production of a full audittrail requires access to the record of patient and operator ID. Complete audits ofquality control values can also be recorded if QC results are stored separately frompatient results.

A touchscreen or a keypad can be used to enter information into POCT analysers. Itis essential that any touchscreen or keypad is designed to be easy to clean.

Consumables for the quantitative analysers vary from self-contained cartridges orcuvettes to multiple individual components. The non-quantitative devices are all urinereagent strips of varying design. Cartridges and cuvettes are packaged individuallyand the packet should not be opened until a measurement is to be made. Urinereagent strips are supplied in pots usually containing 25-100 strips. It is essential toreplace the lid on the pot as soon as a strip has been removed, to preventdeterioration of the remaining strips.

The safe disposal of the used consumables from POCT must be considered. Theseshould not contain hazardous chemicals requiring special treatment but will allcontain patient sample and therefore have to be disposed of as biohazardous waste.Most areas where POCT is performed will already have suitable systems for thedisposal of biohazardous waste.

Service provision, workflow and impact on patient pathways

POCT devices are designed for relatively low sample throughput. More than oneanalyser may be needed by busy clinics. In a well run clinic, the patient can have theHbA1cand urine albumin or ACR measurements performed alongside weight andblood pressure checks before seeing the clinician. With all results available, the

doctor can discuss them with the patient and when necessary alter the treatmentwithout the need for a second visit. There is good evidence that the use of POCmeasurement of HbA1cin both primary and secondary care settings leads to animproved clinical outcome for the patient when compared to measurement in alaboratory [6, 7,28].

There is no evidence to show that POC measurement of urine albuminconcentrations results in improved clinical outcome for the patient but there is clearevidence linking raised urine albumin excretion with early diabetic nephropathy [28].POC urine reagent strip testing for albumin could not be recommended for assessingnon-diabetic nephropathy with respect to improved clinical outcomes [29].


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It is the combined use of the test and treatment that yields an improved healthoutcome in diabetes [28].

Staff requirements, training and instructions

Most POCT device manufacturers recommend that their devices are used byhealthcare professionals; generally all staff grades are suitable provided training andcompetency are documented. Staff chosen to perform POCT must be skilled inobtaining good patient samples and in the case of the visual reading of urine reagentstrips must have good colour vision.

Training is essential even though some suppliers do not offer it. Sufficient trainingsessions must be offered to allow for multiple users of the devices, staff turnover andrefresher training. Sessions may take between 30 minutes and 2 hours depending onthe complexity of the device. Regular competency checks must form part of thetraining scheme. Only staff recorded as trained and competent should be allowed tocarry out POCT. Many hospitals use cascade training; supplier-trained hospital staffcan train other hospital staff, often a role for laboratory trained POC support teamstaff. Some manufacturers produce electronic or online information to assist withtraining and competency checks.

Instruction for use (IFU) and operator manuals supplied with all devices should meetthe 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 aresult; those using a self-contained cartridge or cuvette require the least. Participantsin an ergonomic assessment concluded that the most important attributes of theseanalysers 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 theoperator is under pressure e.g. in accident and emergency departments.


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Urine reagent strip good features:

an automated reader is required to remove all subjective elements of readingthe correct concentrations

sufficient time between reading different analyte results improves accuracyfor 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 theiranalysers. Most suppliers offer an exchange service for a faulty analyser so that theclinical site has a functioning analyser while the faulty one is being repaired.

The ideal POCT device should have minimal maintenance and remain reliable. Themaintenance 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 QCresults into a specific log but electronic storage of results is preferable [24]andbecoming more common. Provision of electronic plotting of QC results on a LeveyJennings plot is an efficient means of monitoring analyser performance. Well-developed analyser software is required for the secure electronic storage of resultstogether with the patient and operator identities needed for reliable result recall andaudit 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 sendthe results to a laboratory information system (LIS) or hospital information system


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(HIS) and in the future to an electronic patient record requires a good IT connectivitysystem.

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 ITconnectivity package enabling such activities as transmission of results to a LIS andremote monitoring of analyser performance from the laboratory. Connectivitypackages are less common amongst smaller POCT devices such as those formeasuring HbA1cand or urine albumin and ACR, but there is a move towards greaterprovision. The most important features of a good connectivity system have beenoutlined 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 thandevice 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


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monitoring of analyser activity allow POCT support staff to use their time mosteffectively.


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Economic considerations 17

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Potential costs and benefits

When deciding if a point of care service should be provided, consideration mustbe 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 theinterface

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 forquantitative laboratory tests

positive effect on patient motivation to achieve better control of diabetessince results can be discussed with the doctor at a single appointment

immediate treatment change, when appropriate, giving better continuity ofcare.

An organisation may have to pay more for POCT than laboratory testing but canbenefit 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 includethe lifetime of the analyser, the costs of the analyser and consumables and theirdisposal, 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 beincluded.


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Cost of analysersThe purchase prices reflect the complexity of the analysers. The more expensiveanalysers generally have more features and better software. None of the devices orconsumables for POCT measurement of HbA1cor urine albumin is currently on thedrug tariff.

Cost of analyser consumables

Self contained cartridges or cuvettes are more expensive than multiple componentconsumables. The number of analytes measured by the cartridge/cuvette is notalways reflected in the cost.

Urine reagent strips provide the least expensive urine albumin measurements butthey do not provide quantitative results.

Pricing is often volume-dependent and potential customers should always obtain aquote from the supplier before making any procurement decision.

Costs of operation

The cost of refrigerated storage space should be considered. Minimal refrigeratedspace may be needed at POC, sufficient only for QC material, but much more maybe needed in the laboratory for consumable stocks (eg cartridges). Devicemaintenance should be minimal and cost very little. The majority of waste isbiohazardous, and will incur some additional disposal costs. The bulkiestconsumables 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 analysistime or the costs of the service, but all can also be viewed in terms of economicbenefits.An analyser has greater potential if it can offer additional analytemeasurements especially if the transition from one to another is quick and simple.Quantitative methods require smaller patient sample volumes which can be animportant factor, particularly for children. Analysers with either or both of thesefeatures could provide savings in space, staff training and purchasing and runningcosts. Provision of an on-board printer saves the space and cost required for aseparate printer.

A robust system for the prevention of measurement and reporting errors can help tominimise costs (including legal costs) associated with inappropriate and ineffective


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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 connectivitypackages. These allow the transfer of patient results with their patient and operatorIDs to the LIS and/or HIS thus facilitating audit. The facility to print results allowsthem 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 rangeensure that the analyser is only used when functioning properly. Automatic reading ofurine 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 toprint results onto labels allows direct attachment to the patients notes savingoperator time. Automatic reading of urine reagent strips reduces operator time. Useof a bar code reader and an IT connectivity package both permit efficient use ofoperating and support staff time. A well developed IT connectivity system would alsoallow for secure long-term storage and retrieval of results by all healthcareprofessionals involved with the patient. The time taken for training will reflect thecomplexity of the device and the range of features. Most suppliers offer initial trainingfree of charge but further training sessions on site may incur charges. Traininggenerally requires 1-2 hours for an analyser and 30-45 minutes for very simpledevices such as urine reagent strips. Some suppliers do not offer any training

sessions. Specific information provided by suppliers to assist with cascade trainingwill save time for hospital staff responsible for these issues.

The cost of a POCT service is influenced by the need for quantitative or non-quantitative results, dictated by clinical requirements. Single cartridges specifically forchecking the optics temperature and electronics of the analyser can be usedrepeatedly to check the functioning of the analyser between liquid QC measurementswithout incurring the cost of measuring a liquid QC. The cost of an interface betweenthe connectivity package and the LIS will probably be the responsibility of thecustomer not the supplier. Any charges incurred in the exchange of a faulty analyserfor a working one during repair need to be balanced against the impact on the patientof not providing the test results for the clinic.


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Purchasing 20

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Purchasing procedures

The Trust Operational Purchasing Procedures Manual provides details of theprocurement process [38].

European Union procurement rules apply to public bodies, including the NHS, for allcontracts worth more than 90,319 (from January 1st2008) [39](appendix 2). Thepurpose of these rules is to open up the public procurement market and ensure thefree movement of goods and services within the EU. In the majority of cases, acompetition is required and decisions should be based on best value.

NHS Supply Chain (NHS SC) offers national contracts or framework agreements forsome products, goods and services. Use of these agreements is not compulsory andNHS organisations may opt to follow local procedures.

Purchasing options

This type of analyser has three main purchasing options. Outright purchase andlease purchase are straightforward. Reagent rental involves provision of an analyserin 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 inaccordance 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 ofany 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.


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Some manufacturers claims to provide a connectivity system may be misleading.They may not be able to provide a working demonstration of the device beinginterfaced since the provision of an interface is usually the responsibility of thecustomer. This can be developmental work with additional hidden costs. There arevery few, if any, truly open connectivity systems able to connect to devices producedby all manufacturers. As a result several separate data streams may have to comeinto the LIS and/or HIS.

Supplier stability

Large multinational companies with significant resources are generally moreeconomically stable than relatively small individual companies. But the stability ofsuch an individual supplier can be indicated by how long they have been in themarket.

Sustainable procurement

The UK Government launched its current strategy for sustainable development,Securing the Future[40]in March 2005. The strategy describes four priorities inprogressing sustainable development:

sustainable production and consumption working towards achieving more withless

natural resource protection and environmental enhancement protecting thenatural 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 fromwhich the analysers and consumables are manufactured and their safe disposal afteruse. Packaging is also an important consideration. Power consumption is lesssignificant as it is low.

Materials

There is a high level of plastic use in the manufacture of the devices and theirconsumables 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 theirconsumables does not currently use any recycled materials (recyclate), nor any


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natural materials therefore none of the materials can be sourced from renewableresources.

Disposal of consumables

Generally used consumables and single use devices will be disposed of in existingcontainers 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, whereassingle use cartridges are relatively bulky.

PackagingConsumable packaging can consist of individual spray foil wrapping, a cardboard boxwhich has an outer cellophane wrapper on some products. Some IFUs are shrinkwrapped in plastic within the box. None of this material is recyclable if it has been in aclinical area as it may have been contaminated and must be disposed of as abiohazard. Outer packaging used for transport of the consumables will usually berecyclable and in some instances is made from recyclate; in other instances virginmaterials are used but they are sourced from Forest Stewardship Council (FSC)certified sustainable sources.

Batteries, power supply and energy consumptionA minority of this type of analyser can use battery power including rechargeablebatteries. All the analysers are intended for use at room temperature and their powerconsumption is very low (tables 1-3).

Power saving features are few, but some analysers automatically switch to standbymode after a short period of inactivity. A few of the analysers utilize LEDs to reduceenergy demand (tables 11 and 12).

Noise output

The noise output of the analysers falls well below the Health and Safety Executiverecommended noise reduction action limits of 85 dBA or 140 dB [41].

End of life disposalConsideration should be given to the likely financial and environmental costs ofdisposal at the end of the products life. Where appropriate, suppliers of equipmentplaced on the market after the 13thAugust 2005 should be able to demonstratecompliance with the UK Waste Electrical and Electronic Equipment (WEEE)regulations (2006) [42].The WEEE regulations place responsibility for financing thecost 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 thepoint at which the equipment is scheduled for disposal by the final user. However, if it


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is subsequently decontaminated such that it no longer poses an infection risk, it isagain covered by the WEEE regulations, and there may be potential to dispose of theunit 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 wouldreduce the environmental impact of the waste. Use of biodegradeable plastic mightbe 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 allresults to be displayed on a single screen could provide the clinician with an instantview of patient status. A similar development for laboratory results could includePOCT where it is linked to the LIS. This would aid the provision of the optimumtreatment and shorter patient stay, with possible cost savings. These developments

and the linking of results to the electronic patient record accessed across differenthealthcare providers could reduce the risk of test duplication and also reduce theamount of paper generated in recording/reporting results. This may bring savings tothe patient, the healthcare provider and the environment.


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Introduction

This market review includes all devices for point of care measurement of HbA1candlow concentration albumin in urine on the UK market in June 2008. All the devicesare CE marked. The prices quoted are list prices (Spring 2008); discounts may beavailable.

The analysers included in this guide could be used in a diabetic clinic setting withinsecondary care and some are suitable for use within primary care if demand issufficient. The urine reagent strips are often used in primary care. Any grade ofappropriately trained staff could use these devices with one exception which requiredlaboratory trained staff. Axis Shield now market the NycoCard only for laboratory usesince the procedure includes pipetting which is a laboratory skill.

The information presented in the market review tables 1-3was selected andgathered 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 themanufacturers 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 5-8).

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 5-8with a poor rating forpoor and very poor scores.

Technical considerations

The specifications of the devices are detailed in tables 1-3.The results of a limitedtechnical evaluation are discussed (page 36)and tables and graphs of the results arepresented in appendix 3.


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Table 1. HbA1cquantitative measurement comparative table (page 1 of 4)

Device A1cNow+ Afinion DCA Vantage

UK launch date 2007 2007 2007

Analysis informationMethodology basis Immunological Boronate affinity Immunological Bo

Calibration traceable to: IFCC standard IFCC standard IFCC standard IF

Reportable range HbA1c(%) 4-13 4-15 2.5-14

Measurement consumable Cartridge Cartridge Cartridge

Sample volume (L) 5 1.5 1

Analysis time (min) 5 3.25 6.5

Quality control material supplied Advice only 2 levels 2 levels

Affected by Hb variants HbF, HbS, HbC andothers

No effect of HbAS,HbAE, HbF, HbS or HbC

HbF >10%, HbS, HbC,HbE

No e

Electronics check During analysis

During start up

1 self-test/day if analyserleft switched on

During start up

Optics cartridge

Durin

Test


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Troubleshooting information onscreen

Error codes Error codesError codes, explanation

+ resolutionErr

Consumable storage long-term 2-8C 2-8C 2-8C

Consumable storage at roomtemperature

90 days 90 days 90 days

Waste collection and disposalUsed cartridge

biohazardUsed cartridge

compressed, biohazardUsed cartridge liquidabsorbed, biohazard

U

Other analytes measured None ACR, CRP ACR


Bar code reader available N/A

Touch screen

On-screen procedure instructions Minimal Brief + symbols Concise Mi

Mandatory ID entry N/A Patient only

Mandatory QC + lockout both

Locked while analysing N/A

Printer and use of labels N/A External On-board + labels Ex

Analyser result storage (Patient +QC)

None 500 P + 500 QC 4000 P + QC

Data management on-board Patient trending

Connectivity currently available N/A but planned


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Audit trail

General information

Size of analyzer (mm) W x D x H 53 x 80 x 15 170 x 320 x 170 287 x 277 x 254 13

Weight of analyser 68 g 5 Kg 3.88 Kg

Power supply Battery Mains Mains Ma

Power useOperation 4.5 Wh < 100Wh 70 Wh

Standby 10 nA 40 Wh N/A

Use of rechargeable batteries N/A N/A N/A

Portable + Case (C) Portable Transportable + C Portable + C

Analyser life span (yr) 1 5 At least 5 10

Costs

Analyser N/A 3,995 3,989

Analyser/consumable financeoptions

PurchasePurchase, reagent

rental, leasePurchase, reagent

rental, leasePur

Test devicesCost / pack size 79 for 10 + monitor 70 for 15 91.08 for 10

Cost / test 7.90 4.66 9.11

Warranty N/A 1 yr 1 yr

Service contract / extendedwarranty

N/A 360/yr 377/yr


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Replace faulty analyser to fix just replace if on contract

Additional training 250/session 88/h 450 + VAT/day ~2

Supplier support

Support staff hours and helpline 8.30-17.00 M-F 9.00-17.00 M-F 24 h/d, 365 d/yr 9.

Consumable ordering options Fax, phone, emailPost, fax, phone, email,

websiteFax, email Fax

Consumable delivery times 1-14d 1d, if order 1pm M-Th 3d 1d,


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Table 2. Urine albumin quantitative measurement comparative table (page 1 of 4)

Device Afinion DCA Vantage Hem

UK launch date 2007 2007 2

Analysis information

Methodologybasis

Albumin Immunological Immunological Immu

Creatinine Enzymatic + colorimetric Colorimetric N

Calibrationtraceable to

Albumin ERM DA 470 * CRM 470 * CRM

Creatinine SRM 914a SRM 914a N

Reportablerange

Albumin (mg/L) 5 - 200 5 - 300 5

Creatinine (mmol/L) 1.5 - 30 1.3 44.2 N

Measurement consumable Cartridge Cartridge Cu

Sample volume (L) 3.5 40

Analysis time (min) 5.5 7

Quality control material supplied 2 levels 2 levels 2 l

Electronics checkDuring start up + 1 self-test/day

if left switched onDuring start up + optics

cartridgeDuring


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Troubleshooting information on screen Error codesError codes, explanation +

resolutionErro

Consumable storage long-term 2-8C 2-8C 2

Consumable storage at room temperature 90 days 90 days3 days, ca

from

Waste collection and disposalUsed cartridge compressed,

biohazardUsed cartridge liquidabsorbed, biohazard

Used cuve

Other analytes measured HbA1c, CRP HbA1c N


Bar code reader available N

Touch screen

On-screen procedure instructions Brief + symbols Concise

Mandatory ID entry available Patient only N

Mandatory QC + lockout both

Locked while analysing

Printer and use of labels External On-board + labels Ex

Analyser result storage (Patient + QC) 500 P + 500 QC 4000 P+QC 600

Data management on-board Patient trending

Connectivity currently available but planned but

Audit trail


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General information

Size of analyzer (cm) W x D x H 17 x 32 x 17 28.7 x 27.7 x 25.4 17.0 x

Weight of analyser 5 Kg 3.88 Kg 0.3

Power supply Mains Mains M

Power useOperation


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Supplier support

Support staff hours and helpline 9.00-17.00 M-F 24 h/d, 365 d/yr 8.00-1

Consumable ordering options Post, fax, phone, email, website Fax, email Post, phon

Consumable delivery times 1 d, if order 13:00 M-Th 3 d 1 d if ord

* ERM-DA470 and CRM 470 are different names for the same material.


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Table 3. Urine albumin non-quantitative measurement comparative table (page 1 of 4)

Device Clinitek Status Microalbustix Uritest 13 G Im

UK launch date 2003 1998 Not known

Analysis information

Methodologybasis

Albumin Colorimetric Colorimetric Colorimetric Imm

Creatinine Colorimetric Colorimetric Colorimetric

Calibrationtraceable to

Albumin CRM 470 CRM 470 Not known C

Creatinine CAS 60-27-5 CAS 60-27-5 Not known

Reportablerange

Albumin (mg/L) 10 - 150 10 - 150 Neg - >100 Neg 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 thelaboratory method at the cutoff point was good (table 31)but the DCA Vantageresults showed slightly better overall agreement (table 26). The Afinion confidenceintervals were slightly narrower than those for the DCA Vantage. Accuracy data forthe analysers agreed with available manufacturers quoted performance. The Afinionand DCA Vantage both showed greater scatter at higher values for both creatinineand ACR results (figures 7 and 8).


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Non-quantitative:Creatinine measurement using the Clinitek Status was goodalthough there were some poor duplicates midway between colour blocks which

were excluded. Creatinine at lower concentrations tended to be overestimated on thevisually read Microalbustix (figure 11a). Uritest 13G creatinine results showed noclear relationship to the laboratory results (figure 10b).

ACR results (figure 11bplotted on a log scale) showed that the Clinitek Statusprovided better discrimination between normal and abnormal ACR values thanMicroalbustix. Only one sample with a raised ACR by the laboratory method gave anormal Clinitek Status result and therefore a normal Clinitek Status result was agood indication that ACR was within normal range; this agreed with another recentstudy [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-quantitativedevices was poorer than that for the quantitative POCT devices (tables 31and 32).Refinements to the Clinitek Status assessment of ACR showed its superiority to thevisually read Microalbustix.

Manufacturers claimed performance for albumin and ACR measurements on theurine reagent strips shows that most fall just short of the recommended sensitivityof> 95% [18](table 27).

Overall conclusion for urinalysis

Quantitative: The NycoCard and DCA Vantage showed slightly better performancefor albumin measurement than the Afinion and HemoCue. The creatinine and ACRmeasurements made by the DCA Vantage were marginally better than those by theAfinion.

Non-quantitative:The Clinitek Status provided the most accurate measurement ofalbumin 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 thealbumin results to the colour blocks and to the unsuitability of their concentrations tothe usual 20 mg/L cutoff point for microalbuminuria [23]. Creatinine colour blockswere distinctive in colour but the results were still very imprecise.


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Operational considerations

Training and instructionsThe suppliers of these devices offer training to suit the customer, generally accepting4-10 trainees per session. The suppliers also offer refresher training and someliterature to assist with training. Two suppliers of urine dipsticks (Uritest 13G andMicral-Test) do not offer any training.

The IFUs and operators manuals supplied with these devices were assessedagainst the British Standard (BS) En 591:2001 which specifies the IFU contentrequired for in vitro diagnostic devices, linked to the requirements of the IVDD. TheIFUs 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 ofevaluators, 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 distributedof which 42 were completed (68%) (tables 5-8). The NycoCard users all worked inlaboratories which may have influenced their opinions. The in2it users wereevaluating the analyser in the laboratory not at POC. No users contact informationwas 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 thanparticipants in the ergonomic assessment. The exception was the in2it.

Based on the features set out on page 12and 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)

HbA1canalysersUrine albumin analysers -quantitative

Urine albumin devices non-quantitative

1 DCA Vantage DCA Vantage Clinitek Status

2 Afinion Afinion ImmunoDip

3 in2it HemoCue Micral-Test

4 A1cNow+ NycoCard Microalbustix

5 NycoCard Uritest 13 G


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Table 5. HbA1cand urine albumin or HbA1conly measurement: ease of use assessment

Device A1cNow+ Afinion DCA Vanta

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

Information displayed on analyser status

Clarity and content of results displayed on screen

Clarity and content of result printout N/A N/A

Overall ease of use

User overall ease of use

Poor: Satisfactory: Good: Very good:


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Table 6. Urine albumin only measurement: ease of use assessment

Device HemoCue

Clinitek

Status Microalbustix

Clarity of short form instructions None

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

Information displayed on analyser status

Clarity and content of results displayed on screen

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 - -

Ease of selecting correct result for strip - -

Overall ease of use

User overall ease of use



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Table 7. HbA1cand urine albumin or HbA1conly measurement: user assessment

Device A1cNow+ (5) Afinion (7) DCA Vantage (7) in2it (6

Would like bar code readerand printer (%)

N/A 50 100 75

Would like good IT links (%) N/A 92 93 100

Maintenance andtroubleshooting

Training

Supplier support

Environmental

Recommend 5/5 5/6 7/7 3/6 (for POC

Poor: Satisfactory: Good: Very good: *NycoCard user comments reflect laboratory use.

Table 8. Urine albumin only measurement: user assessment

Device HemoCue (1) Clinitek Status (4) Microalbustix (3) Uritest 13G (0) Immu

Maintenance andtroubleshooting

N/A No users

Training No users

Supplier support No users

Environmental

No users Recommend 1/1 4/4 3/3 No users



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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 ClinitekStatus where the sample is not enclosed in a cartridge. The DCA Vantage andNycoCard 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 page14.

1. DCA Vantage2. in2it3. Clinitek Status4. Afinion5. A1cNow+6. NycoCard7. HemoCue

Several of the devices have IT connectivity facilities in development.


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Economic considerations

Whole-life costsThe whole-life costs have been calculated from the lifetime of the analyser, plusanalyser, consumable and servicing costs. Costs of power consumed (tables 1-3)and consumable disposal should be low. Analyser disposal costs will have to beborne by the customer unless the analyser has been fully decontaminated. Thesetypes of device are used by a range of staff grades which makes a meaningfulestimate of staff time costs very difficult.

Table 9. Whole life and annual costs for multiuse analysers

Device AfinionDCA

Vantage

HemoCue in2it NycoCardClinitek

StatusWhole oflife cost(500)

17,695 28,644 14,845 31,500 17,694 4,910

Whole oflife 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 outthe measurements. It is well suited to low throughput situations, is extremely portableand requires little operator time. The NycoCard would be expensive in operator time.Although the HemoCue 201 albumin is the least expensive method for measuringurine albumin quantitatively it does not provide the ACR recommended by NICE [9].The Hemocue cuvettes are the only POCT analyser consumables which cannot bestored at room temperature for at least 1 month. The boxes of 25 cuvettes requirelittle 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 developedsoftware. The cheapest test, Uritest 13 G, has inferior design features (table 4)andinadequate technical performance (table 30).


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Purchasing

Supplier stabilityA companys economic stability might influence the choice of supplier. Five of theeight suppliers of these devices are large multinational companies with significantresources. BHR and Chirus have been supplying a variety of POCT devices for 18and 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?

A1cNow+In2it

HemoCue

Uritest 13 G

Clinitek Status

Microalbustix

ImmunoDipMicral-Test

Afinion

DCA Vantage

NycoCard

Urine albumin

/ACR only

HbA1c only

HbA1c and urine

albumin /ACR


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Figure 2. Choice of analyser measuring HbA1cand urine albumin

NoNo

YesNo

No

Yes

Yes

NoYes

NoYes

Quantitative?

Easy to use for

POCT?

Analysis time

< 4 minutes?

Record patient

& operator IDs?

Record patient

& operator IDs?

NycoCard

Yes

No

IT connectivity?IT connectivity?

Afinion

Yes

DCA Vantage


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Figure 3. Choice of analyser measuring HbA1conly

No

YesNo

Yes

No

Yes

No

Yes

Quantitative?

Easy to use for

POCT?

Analysis time

< 4 minutes?

Record patient& operator IDs?

YesNo

IT connectivity?

A1cNow+

in2it


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Figure 4. Choice of devices measuring urine albumin

YesYes

No

Yes No

Yes No

Yes

Quantitative?

Easy to use for

POCT?

Record patient

& operatorIDs?

Record patient

& operatorIDs?

Yes

Need stringenttiming?

ITconnectivity?

NoYes

Analysis time

< 4 minutes?

No

No

No

Yes

Yes

Easy to use for

POCT?

Analysis time

< 4 minutes?

No

HemoCue

Uritest 13 G

Micral-Test ImmunoDip

MicroalbustixClinitek Status No Yes

Needs colourmatching?

No


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Sustainable development

Sustainable development is a growing issue. Questionnaires covering various aspects of sustainabeach supplier. Responses were mixed and it is recognised that many companies are only just starticonsideration in their production systems. Tables 11 and 12 summarise the comparable informatio

Table 11. HbA1c and urine albumin or HbA1conly measurement: sustainable development issues

Device A1cNow+ Afinion DCA Vantage in2

Power saving features N/A NoneAutomatic switch to power

save after 30 minAutomatic standby aft

Designed for ease of maintenanceand repair

N/A Only at man

Audible noiseoutput (dBA ordB)

Operation 0 50 dBA 48 dBA < 65 dBA

Standby 0 0 N/A 0

Percentage of the packaging fromrecyclate

Not known Not known Not knownNone but virgfrom sustaine

Table 12. Urine albumin only measurement: sustainable development issues

Device HemoCue Clinitek Status Microalbustix Uritest 13 G

Power saving features None None N/A N/A

Designed for ease ofmaintenance and repair

N/A N/A

Audible noiseoutput (dB)

Operation Minimal 17.8 dB N/A N/A

Standby 0 N/A N/A N/A

Percentage of the packagingfrom recyclate

Not known75-100 outer boxes and foil for transport .

Virgin materials from FSC certified sources.Not known


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Summaries

The information gathered for this report is summarised in 11 device specific tables (tables 13-23).

Table 13. A1cNow+ summary

A1cNow+ Overall rating: Satisfactor

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

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 tohaemoglobin variant interference

Small size increases risk of losing device

Expensive

Not possible to remove battery beforedisposal

Summary

The A1cNow+ is a vwith single use cartris supplied as a pacfor 10 measuremen

Consumable storadays

Performance assesto laboratory measuunder-treatment of t

Overall ease of useergonomic assessm

Training quality: gereceived any

Recommended by

Potential use:low as the GP surgery o

community nurse; le


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Table 14. Afinion summary

Afinion Overall rating: Goo

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 duringmeasurement

Short analysis time (3.5 min HbA1c, 5.5 minACR)

Good liquid containment in used cartridge

Screen result in large font

Easy recall of previous results

Reliable

Compact and transportable

Limitations

Icon only screen instructions

No spare capillaries

No prompt to enter operator ID for eachsample

Poor QC solutions material, hard to re-suspend

No QC lockout, on-board QC ranges or QCprogramme

No real time countdown during analysis

Error codes only on screen, need manualfor resolution

No on-board printer

Lack of IT connectivity

Summary

The Afinion is a fairly cartridges for HbA1c, AExternal barcode read

Consumable storagedays

Performance assess

laboratory results for H

Overall ease of use: symbols in instruction

alone

Training quality: gen

Recommended by us

Potential use:in a cli


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Table 15. DCA Vantage summary

DCA Vantage Overall rating: Goo

Strengths


Straightforward to use, clear on-screeninstructions

Entry of IDs can be mandatory, audit trailpossible

QC lockout if QC not measured, maintenanceprompts

Optical check cartridge for electronics check

Timed count down during analysis

Clear screen results, graphical patient resulttrending

Reliable results and good EQA results

Results can be printed on labels anddownloaded to computer

Errors codes explained, solutions given on-screen

IT connectivity potential

Ease of training

Limitations

Relatively quite large and heavy, not veryportable

Patient ID not shown during analysis

Card bar code swiping adds to proceduresteps

Short sample if capillary wiping techniquepoor

6 or 7 min analysis time too long if clinic verybusy

Awkward cartridge removal

Liquid leak from some used cartridges ondisposal

Printout result font too small

No on-board QC programme

Security settings insufficient for POCT policies

Need interface to LIMS

Immunological method susceptible tohaemoglobin variant interference

Thermal printer

Summary

The DCA Vantage issingle use cartridge

An external barcode

Consumable storadays

Performance assesagreement with labooverestimate abovevery good agreeme

at least 15 mg/mmoOverall ease of use

Training quality: geof some users was

Recommended by

Potential use: in a

would be needed fomeasurements werethe time taken for ea


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Table 17. NycoCard summary

NycoCard Overall rating: Poo

Strengths


Boronate affinity methodology for HbA1c

No complicated calibrations

No capillary wiping

Same volume for all additions of liquid in onetest

Staff training good

Limitations

No ACR

Screen very small

No patient or operator ID entry

Too many awkward steps throughout theprocedure

Timer required

Memory only 1 result

Not interfaced with computer

Turns itself off too quickly (10 min)

Summary

The NycoCard is a sfor the measuremenand D-Dimer. Axis SNycoCard for labora

Consumable storaat room temperature

Performance assescompared to laboratof urine albumin res

Overall ease of usethe ergonomic assethey all used the de

Training quality: go

Recommended by

Potential use: in a

throughput


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Table 18. HemoCue summary

HemoCue Overall rating: Satisfactor

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 itis connected during analysis

Limitations

No ACR

No patient or operator ID entry, also limitsmemory 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 forresolution

Thermal printer

Summary

The HemoCue 201 with single use cuverequiring additional

Consumable storatemperature for 3 dathe fridge if care is t

Performance assecomparison with labnegative and quite h

concentrationOverall ease of useassessment and ve

Training quality: gogiven too early in re

Recommended by

Potential use: in a shortcoming and theclinical guidance [9]


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Table 19. Clinitek Status summary

Clinitek Status Overall rating: Very good for

Strengths

Multi-purpose reader detecting alternativestrips automatically

More than one analyte is measured on theClinitek Microalbumin strips

Sample quality can be recorded

Ease of use

ACR estimation provided, using opticalreadings

On-board printer

Reduces operator error

Results are accurately timed

Removes operator subjective strip reading

Limitations

Semi-quantitative

Instructions on bottle and IFU sheet do notmatch exactly

Dip, wipe and load time (8 s) very short

Regular cleaning of tray and calibration stripimportant

Thermal printer

No power saving features

Summary

The Clinitek Status automatic reading oMicroalbustix) and Cprovides an accuratwhich is electronicaquality of the operatlighting, vital for the urine reagent strips

Consumable stora

temperaturePerformance asseslaboratory results fosemi-quantitative na

Overall ease of use

Training quality: go

Recommended by

Potential use:in a clinic may only requtime is short


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Table 20. Microalbustix summary

Microalbustix Overall rating: Satisfactory for

Strengths

More than one analyte is measured on thesestrips

Easy to use

ACR estimation available

Minimum space required

Quick test

Long shelf life

Limitations

Semi-quantitative

Different languages on ACR chart confusing

Dependent on subjective result reading

Requires ambient lighting and operator colourvision of a set standard

Requires stringent timing of result reading

Analyte reading times close together (10 s)

Manual result recording

Summary

Microalbustix is a urquantitative measurcreatinine concentraoff an approximate Asemi-quantitative reread in a well lit areacolour vision. A timeresult reading. Thermanually recording urine reagent strip r

visual reading.

Consumable storatemperature

Performance assesoverestimation at lopotentially giving rismicroalbuminuria

Overall ease of use

Training quality: ge

Recommended by

Potential use:in a


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Table 21. Uritest summary

Uritest 13G Overall rating: Poor for

Strengths

Albumin and creatinine measurementsavailable plus 11 other analytes

Minimum space required

Quick test

Long shelf life

Limitations

Semi-quantitative

Strip too long to fit into universal container fordipping

Need to rest dipped stick on colour chart tocheck block alignment with chart


13 results all to be read and recorded withinone minute

Minimal difference in colour between albuminchart colour blocks

Albumin chart block concentrations do notshow what concentratons are considerednegative

Summary

Uritest 13G is a urinquantitative measurincluding albumin an

Consumable storatemperature

Performance asses

discriminate betweereadings across thethe highest value co

agreement of creatilaboratory was not csemi-quantitative na


Training quality: noreading of the strip pinternet by the evalu

Recommended by

Potential use:Uritefor use on the grounperformance, poor d

supplier support


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Table 22. ImmunoDip summary

ImmunoDip Overall rating: Good for

Strengths

Immunological method

Ease of use

Good IFU

Requires colour intensity matching not colourshade matching unlike other urine reagentstrips

Long shelf life

Limitations

Qualitative

No ACR

Requires good ambient lighting and visualability to discern differences in blue lineintensity

Minimum read time (3 min) quite long for aurine dipping device.

Need a rack to stand urine container in duringdipping to avoid spillage

No automatic reader available

Expensive

Summary

ImmunoDip is a devalbumin in urine; nebe read in a well lit ashould be a reliableresults. Use of an apreferable to visual

Consumable stora

temperature

Performance asses

laboratory results giresults

Overall ease of useassessment and ve

Training quality: gouser had not receive

Recommended by

Potential use:in a throughput; less sui


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Table 23. Micral-Test summary

Micral-Test Overall rating: Satisfactory for

Strengths

Immunological method

No blotting required

1-5 min reading period

Quick test

Colour of different chart blocks distinctive

Long shelf life

Limitations

Semi-quantitative

No ACR

Care needed to dip correctly


Different colour reading convention compareto other urine reagent strips

No training may result in incorrect use andwasted strips.

Summary

Micral-Test is a urinquantitative measurconcentration. Micraarea by a well-traineand a timer. There smanually recording urine reagent strip rvisual reading.

Consumable stora

monthsPerformance asses

overestimation at lopotentially giving rismicroalbuminuria


Training quality: nosupplier but IFU we

Recommended by

Potential use: in a


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Acknowledgements 62

CEP08057: June 2009

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, Bio-Rad 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 PathologyPlus, Royal Surrey County and Frimley Park Hospitals

Respondents to our survey questionnaire


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Glossary 63

CEP08057: June 2009

ACR albumin:creatinine ratio (mg albumin/mmol creatinine)

Average bias represents the mean difference between the POCmethod and the laboratory method used as a referencemethod. It is an indication of accuracy.

Confidence interval gives a measure of the range of result deviations fromthe 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 ofone of the globin chains of the haemoglobin molecule

Levey Jennings plot a graph of quality control data showing how well theanalytical test is performing

NGSP National Glycohemoglobin Standardization Program.

Its purpose is to standardise glycated haemoglobin testresults so that all method results are comparable tothose 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 devicecan provide an accurate result

Semi-quantitative providing an approximation of the quantity or amount ofa substance; between quantitative and qualitative

Sensitivity (in thisreport)

percentage of microalbuminuria positive tests byreference method which are positive by POCT

Specificity (in thisreport)

percentage of microalbuminuria negative tests byreference method which are negative by POCT

Virgin materials materials that have not been used in production beforei.e. not recyclate


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References 64

CEP08057: June 2009

1. Report of the Review of NHS Pathology Services in England. Chaired by LordCarter of Coles. Department of Health 2006.

2. Guidelines for the safe and effective management and use of Point of CareTesting Approved by the Academy of Medical Laboratory Science, Associationof Clinical Biochemists in Ireland, Irish Medicines Board and RCPI Faculty ofPathology November 28, 2007.

3. Report of the Second Phase of the Review of NHS Pathology Services inEngland. Chaired by Lord Carter of Coles. Department of Health 2008.

4. Diabetes in the UK 2004. A report from Diabetes UK October 2004. Availablefrom http://www.library.nhs.uk/DIABETES/ViewResource.aspx?resID=82430

5. The Diabetes Control and Complications Trial (DCCT) . Links to documentsavailable 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 KingdomProspective 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 Clini

buyers guide urine monitors for diabetes

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