urinalysis from roche what else… - roche … · urinalysis from roche expertise coming from a...

Urinalysis from RocheWhat else…

Urinalysis from Roche

Expertise coming from a long tradition of more than 25 years

…suits your daily environment

Combur-Test®

Visual reading

Urisys® 1100

~30 samples per day

cobas u 411

~80 samples per day

Urisys® 2400

~100 samples per day

…guarantees results you can trust in

No ascorbic acid inter-ference up to 750mg/L. Securing no false negative results for Glucose and Blood

Patented net sealing tech-nology provides higher analytical sensitivity

Compensation pad for strongly colored samples

Strips also available in cassettes for excellent convenience

…simplifies your workload

All test pad results easily readable after 60 seconds

Improve data input with barcode reader or key-board

Consolidation of strip and microscopy workflows

Automatic upload of test results via host connec-tivity

Roche’s portfolio…

COBAS, COBAS U, LIFE NEEDS ANSWERS, COMBUR-TEST and URISYS are trademarks of Roche.

©2010 Roche

Roche Diagnostics Ltd.CH-6343 RotkreuzSwitzerlandwww.roche.com

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Ascorbic acid - Vitamin CHealthy, powerful and interfering

Be attentiveConsider that laboratories testing urine samples regularly found high amounts of ascorbic acid (≥400 mg/L) in a significant proportion of a routinely tested population 1

Identify the problemRecognize the potential of ascorbic acid interference on urine test strips based on the peroxidase redox indicator test principle

Diminish adulterating influencesEliminate the interference of ascorbic acid in urine test strips and prevent false negative results, which necessitate a retest-ing of patients or a more expensive microscopic examination

Find the answerDo not miss the opportunity to detect symptoms of a potentially serious disease. Use ascorbic acid resistant urine test strips and detect immediately reliable and precise results

Solve the problemUse iodate impregnated components to minimize the influence of ascorbic acid on blood and glucose test pads even under high levels of ascorbic acid (up to 750 mg/L)

Feel safeAvoid potentially serious and costly consequences of false negative results for doctor and patient using iodate impreg-nated urine strips such as applied in Combur-Test®

COBAS, LIFE NEEDS ANSWERS, COMBUR-TEST and URISYS are trademarks of Roche.

©2010 Roche


Ascorbic acid - Vitamin CSpecifications

Definition

Water soluble vitamin Chemical name: 2-oxo-L-threo-hexono-1,4-lactone-2,3-enediol A six-carbon compound, structurally related to glucose

Characteristics

Average half life: 10-20 days 2

Elimination via the urine Renal threshold: plasma ascorbate concentrations of about 1.2-1.8 mg/dL corresponding to 60 mg doses per day 3-6

Average body tissue of an adult stores 1.2-2.0 g presumably maintained by taking 60-75 mg per day 3-5,7,8

RDA* 90 mg per day for an adult male (set by the US Food and Nutrition Board in 2000) 9

Ingestion of 60 mg/day prevents the development of scurvy for 30-45 days with a diet lacking vitamin C 3,4,7,8

Sources

Natural: fresh fruits and vegetables, e.g., oranges, lemons, grapefruits, watermelons, papayas, strawberries, green leafy vegetables, tomatoes, broccoli, etc.Synthetic: used in vitamin preparation, as preservative and antioxidant (e.g., E300, E301, E302, E303, E304), discoloration inhibitor, supplement in tablets, food additive

Consumption The most frequently used vitamin supplement in the world10

Worldwide annual demand in 1995 was evaluated at 60.000 tons11

Functions

Required for many metabolic functions in humans and cofactor for lots of metabolic reactionsPotent reducing agent playing an important role in the antioxidant defense system, immune competence, and in strengthening resistance to infectionVitamin C prevents DNA mutations and might be important in treating certain cancers, heart disease and other chronic diseases

Interference

Ascorbic acid has the ability to prevent oxidization of indicator substances in urine test strips e.g. in peroxidase redox indicator test principle. Interference can be removed using iodate test components such as applied in Combur-Test®

* Recommended daily allowance

References1. Nagel, D., Seiler, D., Hohenberger, E.F., Ziegler, M. (2006). Investigations of ascorbic acid interference in urine test strips. Clin Lab; 52:149-153.2. Hellman, L., Burns, J.J. (1958). Metabolism of L-ascorbic acid-1-C14 in man. J Biol Chem; 230:923-930.3. Baker, E.M., Hodges, R.E., Hood, J., Sauberlich, H.E., March, S.C. (1969). Metabolism of ascorbic-1-14C acid in experimental human scurvy. Am J Clin Nutr; 22:549-558.4. Baker, E.M., Hodges, R.E., Hood, J., Sauberlich, H.E., March, S.C., Canham, J.E. (1971). Metabolism of 14C- and 3H-labeled L-ascorbic acid in human scurvy. Am J Clin Nutr; 24:444-454.5. Kallner, A., Hartmann, D., Hornig, D. (1979). Steady-state turnover and body pool of ascorbic acid in man. Am J Clin Nutr; 32:530-539.6. Pietrzik, K., Loew, D., Golly, I. (2008). Vitamin C. In: Handbuch Vitamine. Für Prophylaxe, Therapie und Beratung. Munich: Urban & Fischer, Elsevier GmbH; 173-185.7. Hodges, R.E., Baker, E.M., Hood, J., Sauberlich, H.E., March, S.C. (1969). Experimental scurvy in man. Am J Clin Nutr; 22:535-548.8. Hodges, R.E., Hood, J., Canham, J.E., Sauberlich, H.E., Baker, E.M. (1971). Clinical manifestations of ascorbic acid deficiency in man. Am J Clin Nutr; 24:432-443.9. Food and Nutrition Board IoM, National Academies. (2008). Dietary Reference Intakes: Recommended Intakes for Individuals, Vitamins. Washington D.C.

10. Naidu, K.A. (2003). Vitamin C in human health and disease is still a mystery? An overview. Nutr J; 2:7.11. Elvers, B., Hawkinds, S. (1996). Ullmann’s Encyclopedia of Industrial Chemistry.

Chronic kidney disease (CKD)Chronic, often unrecognised, and serious

Be aware of the consequencesRemember that CKD is a common problem with consequences that can severely compromise patients’ quality of life. Diabetes and hypertension are now the major causes of end-stage CKD worldwide.1

Recognise the signs and symptomsNote that deterioration of kidney function in CKD is usually slow. Symptoms of worsening kidney function can therefore be nonspecific and may go undetected.3 Only regular and specific testing of high-risk-groups can detect the first signs of the disease in the urine. Benefit by taking precautionsBe aware of the medical and economic importance of detecting CKD at an early stage.3 Combur urine test strips are an important and cost-effective diagnostic instrument for detecting albumin in the urine, their ease of use facilitating early diagnosis. Early treat-ment can slow progression and reduce cardiovascular risk.3

Be alertPay attention to elderly or overweight patients with diabetes or hypertension or a family history of CKD. Early detection and management with urinalysis can prevent or delay progression to end-stage kidney failure.2

Obtain results quickly and easilyOffer your patients first-line diagnostics to obtain quick and reliable information on pathological changes in the urine. Routine testing of the urine with Combur test strips to detect protein and red as well as white blood cells is the first step in the diagnosis of CKD.

Let urinalysis help youUse urinalysis, a simple procedure with high sensitivity and specificity, to screen asymptomatic patients for CKD in your office. Persistent proteinuria is a marker of kidney damage, a key prognostic finding, and a guide to therapy.4

COBAS, LIFE NEEDS ANSWERS and COMBUR-TEST are trademarks of Roche.

©2010 Roche


Chronic kidney disease (CKD)Features

Definition Kidney damage: defined by structural or functional abnormalities of the kidney, with or without decreased glomerular filtration rate (GFR < 60 mL per minute per 1.73 m2 for three months or more, with or without kidney damage) 2

Epidemiology Overall CKD prevalence in a European general population: 10.2% (US: 11.5%).5

Prevalence of stage 4 and 5 in hospitalized patients aged < 30 years: 1%; aged > 80 years: 12%.6

Over 2 million patients worldwide require maintenance dialysis.7

Classification 4,8

Screening Regular and specific testing (including urine dipstick, GFR, blood pressure) of high-risk-groups.

Risk factors 4 Diabetes, hypertension, cardiovascular disease, structural renal tract disease, renal calculi or prostatic hypertrophy, multisystem diseases with potential kidney involvement, systemic lupus erythematosus, family history of stage 5 CKD, hereditary kidney disease, opportunistic detection of hematuria or proteinuria, the elderly.

Symptoms Symptoms of worsening kidney function can be nonspecific.Increase in urinary protein or serum creatinine.With decreasing kidney function: high blood pressure, urea accumulation (azotemia, uremia), hyperkalemia, anemia, fluid volume overload (edema, pulmonary edema), hyperphosphatemia, hypocalcemia, metabolic acidosis, atherosclerosis, cardiovascular disease, etc.

Diagnosis 4 All patients: measurement of blood pressure, examination of urine sediment or dipstick for protein and red and white blood cells, further urinalysis as required, serum creatinine to estimate GFR.Selected patients: imaging of the kidneys (ultrasound, CT), serum electrolytes, urinary concentration/dilution, pH, biopsy.4

Therapy Slow down progression, treatment of underlying disease, if necessary dialysis, last resort: transplantation.

References1. Levey, A.S., Atkins, R., Coresh, J., et al. (2007). Chronic kidney disease as a global public health problem: approaches and initiatives - a position statement from Kidney Disease

Improving Global Outcomes. Kidney Int; 72:247-259.2. Johnson, C.A., Levey, A.S., Coresh, J., Levin, A., Lau, J., Eknoyan, G. (2004). Clinical practice guidelines for chronic kidney disease in adults: Part I. Definition, disease stages,

evaluation, treatment, and risk factors. Am Fam Physician; 70:869-876.3. National Institute for Health and Clinical Excellence. (2008). Clinical guideline 73: Chronic kidney disease. London.4. National Kidney Foundation. (2002). K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis.;392 suppl 1:S1–266.5. Hallan, S.I., Coresh, J., Astor, B.C., et al. (2006). International comparison of the relationship of chronic kidney disease prevalence and ESRD risk. J Am Soc Nephrol; 17:2275-2284.6. Marsik, C., Endler, G., Gulesserian, T., Wagner, O.F., Sunder-Plassmann, G. (2008). Classification of chronic kidney disease by estimated glomerular filtration rate. Eur J Clin Invest; 38:253-259.7. Xue, J.L., Ma, J.Z., Louis, T.A., Collins, A.J. (2001). Forecast of the number of patients with end-stage renal disease in the United States to the year 2010. J Am Soc Nephrol; 12:2753-2758.8. Winzer, C., Pohanka, E. (2006). Sinn und Unsinn der Kreatinin-Bestimmung. Nephro Skript; 9:6-10.

Evaluation for

proteinuria

Rec check at periodic

health evaluation

Diagnostic evaluation

Consulta-tion

Treatment

Albumin/ creatinine ratio

Total protein/creatinine ratio

Negative

$ 1+

Positive

Negative/ trace

> 30 mg/g

# 200 mg/g

# 30 mg/g

> 200 mg/g

Albumin- specific dipstick

Standard dipstick

at i risk

not at i risk

0

Replacement Preparationfor replacement

Evaluating, treating complications

Estimating, slowing progression

Diagnosis, treatment of comorbid conditions

Stage 5GFR <15mL/min

Stage 4GFR 15-29mL/min



Stage 1GFR ≥90mL/min

177354530707884

24681012

10

Not sensitive to serum creatinine

Standard value

Persistent albuminuriaSensitive to serum creatinine

20 30 40 50 60 70 80 90Glomerular filtration rate [mL/min]

100 110 120 130

Ser

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cobas u 411 analyzerFast, flexible and competent

Considered for workloads of approximately 80 samples per day …and what it takes to further optimize workflow

Define your own paceImpact workload with flexibility of continuous test strip loading

Consolidate your analysisWork parallel on the cobas u 411 analyzer and its sediment terminal as a result of a consolidated work- and dataflow for strip analysis and microscopy. Ease documentation and improve overview of patient records with single print-out for strip and microscopic information

Ease workloadReduce manual work with sample identification via barcode reader or download from host, electronic transfer of sediment work list and printable QC results

Judge at one glanceDifferentiate quickly normal and abnormal results or samples to sieve for microscopy examination with availability of user-definable flags

Ensure comparabilityStandardize microscopy result reporting with selection of pre-defined result ranges on the sediment terminal

Secure your investmentStay easily up-to-date with simplified software upload via USB slot

COBAS, COBAS U, LIFE NEEDS ANSWERS, COMBUR-TEST and URISYS are trademarks of Roche.

©2010 Roche


cobas u 411 analyzerTechnical specifications

Instrument System Semi-automated urine test strip analyzer

Type Reflectance photometer

Measuring system Wave lengths: 470 nm, 555 nm, 620 nm

Throughput Approx. 600 test strips/h

Memory 1000 sample results, 300 control results (3 levels)

User interface LCD touch screen (90x120 mm)

Printer Thermal printer

Certificates CE, UL, CB, CUL

Physical dimensions

Width: 42.5 cmDepth: 34.0 cmHeight: 26.0 cm

Weight Approx. 12 kg

Strips* Test strips Combur 10 Test® M

Parameters

Specific gravity, pH, leukocytes, nitrite, protein, glu-cose, ketones, urobilinogen, bilirubin, blood (erythrocytes/ hemoglobin), color

Calibration Control-Test M calibration strip

Connectivity System interfaces Serial interfaces to barcode reader, sediment terminal and PC/Host; USB Slot

Host protocols ASTM + and Urisys® 2400 ASTM

Sample identification Sample ID via manual entry, barcode reader or download from host

Accessories Type Barcode reader, Sediment Terminal

Supported barcode types Code 39, Code 128, NW 7 (Codabar), ITF (Interleaved 2 of 5)

* Combur Test® strips are marketed under Chemstrip® in United States and Canada.

Combur-Test® strip technologyAccurate, safe and protective

Be confident with the resultsCount on protection and stable performance since sensitive areas are protected against contact, contamination or abrasion with the application of a nylon mesh

Have no doubtsBenefit from a uniform color development of test pads due to the usage of a fine porous nylon mesh

Believe in what you seeBe convinced of your diagnosis. Identify even slight patho-logical changes in the urine as a result of high sensitivity and clear color changes in the test area

Detect UTI for surePrevent false leukocyte results through improved reagent stability in the leukocyte test pad

Don’t worry with ascorbic acidAvoid patient revisits just because of vitamin C interference with iodate impregnated components protecting blood and glucose detection even from high levels of ascorbic acid

Rely on qualityProvide a basis for standardized diagnostic procedures with the application of high-quality urine test strips based on years of research and development

Nylon mesh Reagent paper

Absorbent paperCarrier foil


©2010 Roche


Combur-Test® strip technologySpecifications

Nylon mesh fixing of components – unique sealing technology

No interference with glue components Avoidance of contamination by protective functionUniform liquid penetration and color developmentNo run over of reaction color

Stable reaction colors Synchronized reaction time All in 60 seconds

Sturdy plastic carrier foil No splashing of urine, hygienic strip readingAbsorbent paper

Iodate impregnated component

Protects blood and glucose test areas efficiently from ascorbic acid interference and false-negative results by oxidization even at high concentrations of vitamin C. When five common 10 parameter urine test strips are compared, Combur-Test® strip showed the highest resistance to ascorbic acid interference at higher hemoglobin or glucose concentrations 1:

At a hemoglobin concentration of 0.075 mg/dL, Combur-Test® strips were the only brand to register a correct analysis with ascorbic acid levels as high as 400 mg/L 1

At a glucose concentration of 300 mg/L, Combur-Test® strips were the only brand to show consistently accurate results, even at an ascorbic acid level of 1000 mg/L 1

Additional diazonium salt impregnated mesh

Improves reagent stability in the leukocyte test pad

Absorbent paper Prevents chemical interference

Low test detection limits

High sensitivity and specificityWith no ascorbic acid present, only three out of five tests were able to detect pathologically relevant low hemoglobin and glucose concentrations of 0.03 mg/dL and 50 mg/dL, respectively 1

Reliable visual evaluation Colorfast printing colors on the labelReading of all test pads at once at a consistent reading time

References1. Nagel, D., Seiler, D., Hohenberger, E.F., Ziegler, M. (2006). Investigations of ascorbic acid interference in urine test strips. Clin Lab; 52:149-153.

Hemoglobin (Target value of 0.075 mg/dL = 25 Ery/µL)

Ascorbic acid interference in routine analysis

Glucose (Target value of 300 mg/dL)

Glu

cose

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]

Combur10 test® UX from Roche

Ascorbic acid [mg/L]Ascorbic acid [mg/L]

300

500

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Combur 10 Other BrandsCombur 10 Other Brands Target value Target value

Combur10 test® UX from Roche25

10

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[Ery

/µL]

Combur-Test® strips*Precise, secure and easy

A quality choice for professional use.

Be on the safe sideBe independent from interferences of glued components as a result of an unique sealing technology

Be accurateDetect even low concentrations of erythrocytes/hemoglobin (5-10 Ery/μL)

Be specificStop test area colors from running through an absorbent paper

Find an immediate answer to ascorbic acidAvoid retesting and prevent false-negative results in glucose and blood even under high levels of ascorbic acid (up to 750 mg/L) with the application of an iodate impregnated mesh layer

Results you can trustReduce risk of false results through compensation of strong intrinsic urine coloration with the availability of a color compen-sation pad **

Choose the easy wayEase analysis of results with a consistent reading time of 60 seconds for all parameters. Benefit from advanced and hygienic strip handling with possibility of reading tip down


©2010 Roche


Combur-Test® strips*Technical specifications

Parameter combinations Parameters

Name SG pH LEU NIT PRO GLU KET UBG BIL BL

Combur 2 Test • •Combur 3 Test • • •

Combur 3 Test E • • •Combur 4 Test • • • •Combur 5 Test • • • • •Combur 6 Test • • • • • •Combur 7 Test • • • • • • •Combur 9 Test • • • • • • • • •

Combur 10 Test • • • • • • • • • •Local availability might differ, please check with your local representative

Test construction Composition Reagent paper and underlying absorbent paper are sealed with a thin porous nylon mesh and fixed to a carrier foil

Nylon mesh features

Protection from strip contamination.Homogenous liquid distribution and uniform color development.Prevention from falsification of the color by glue

Practical detection limit

Detection limit is made such that even slight pathological changes in the urine are made visible by a clear color change in the test area

Vial construction Composition Protection of test strips from atmospheric humidity with drying agent filled cap

Color Scale Special colorfast printing colors on the vial label allow easy and reliable evaluation of the resultsy

* Combur Test® strips are marketed under Chemstrip® in United States and Canada.

** Only available for instrument tests

Diabetes mellitusSweet, sugar-sweet, and bitter-sweet

Be aware of the high prevalenceTake note that by 2030 about 438 million people worldwide will suffer from diabetes, corresponding to 7.7% of the adult popula-tion aged between 20 and 79 years.1 This means an increase of 54% compared to 2010.1

Face the factsBe aware that type 2 diabetes often goes undiagnosed until com-plications such as diabetic nephropathy, retinopathy, neuropathy, or atherosclerosis appear. In a third of people with diabetes the disease is undiagnosed.2 Depending on the population studied, about 50% of diabetes patients die of cardiovascular diseases.1

Take advantageUse glucose-sensitive test strips to test for glucose in the urine and thus obtain information on type 2 diabetes by means of a simple test. Type 2 diabetes is the most common form of diabetes, accounting for 90–95%* of all cases.1

Discard misconceptionsRemember that despite the existence of a renal threshold for glucose, urinalysis is an important and viable diagnostic tool for screening for diabetes. Positive results of urinalysis can indicate the presence of diabetes and therefore call for a diabetes work-up.

Prevent complications by early diagnosisScreen asymptomatic people regularly for pre-diabetes and type 2 diabetes with urine test strips. All people aged 45 years or older, especially if overweight or obese, and younger individuals with additional risk factors should be tested.2

Benefit your patients todayUse easy-to-use and cost-effective Combur urine test strips routinely for primary diabetes screening and thus benefit your patients by reducing their risk of acute and long-term complica-tions of diabetes.


©2010 Roche


Diabetes mellitusFeatures

Definition Group of metabolic diseases characterised by hyperglycemia resulting from defects in insulin secretion, insulin action, or both.

Epidemiology 438 million people worldwide (7.7% of the adult population) will suffer from diabetes by 2030, with higher prevalence in developed than in developing countries.1

Types** •Type1diabetes:autoimmunedestructionofthebetacellsofthepancreaswithconsequentinsulin deficiency.

•Type2diabetes:abnormalitiesthatresultinresistancetoinsulinaction(metabolicsyndromeisconsideredto be a precursor).

Othercauses:geneticdefectsofthepancreaticbetacellfunctionorinsulinaction,diseasesoftheexocrinepancreas, endocrinopathies, drug- or chemical-induced diabetes.

Screening All individuals ≥ 45 years, particularly those with a body mass index ≥ 25 kg/m2.If risk factors for diabetes are present, testing should be considered at a younger age or be carried out more frequently.Determination of urine glucose (Combur urine test strips) is a common screening test for possible diabetes. A positive result might be indicative of the presence of diabetes and should lead to a diabetes work-up.

Risk factors Obesity, apple-shaped figure, age, family history, sedentary lifestyle, history of diabetes in pregnancy, impaired glucose tolerance, high blood pressure, high cholesterol or other fats in the blood; Aboriginal, African, Latin American, Asian or Indian ethnic ancestry.

Symptoms 1 •Type1diabetes: Symptomsmaydevelopquiterapidly(weeksormonths):polyuria,polydipsia,significantweightloss,

polyphagia/constant hunger, glycosuria, diabetic ketoacidosis, fatigue, etc.

•Type2diabetes: Symptomsusuallydevelopmoreslowly:polyuria,polydipsia,polyphagia/obesity,glycosuria,diabeticketoaci-

dosis, etc.

Diagnosis 3 1. Symptoms of diabetes and a casual plasma glucose ≥ 200 mg/dL (11.1 mmol/L) or2. Fasting plasma glucose ≥ 126 mg/dL (7.0 mmol/L) or3. 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during a 75 g oral glucose tolerance test

Therapy 2 •Type1diabetes 1. Use of multiple-dose insulin injections (3–4 injections per day of basal and prandial insulin)

or continuous subcutaneous insulin infusion therapy. 2. Matching of prandial insulin to carbohydrate intake, premeal blood glucose, and anticipated activity. 3. For many patients (especially if hypoglycemia is a problem), use of insulin analogues.

•Type2diabetes 1. Intervention at the time of diagnosis with metformin in combination with lifestyle changes

(medical nutrition therapy and exercise). 2. Continuing timely augmentation of therapy with additional agents (including early initiation of

insulin therapy) as a means of achieving and maintaining recommended levels of glycemic control.

Complications Diabetic nephropathy, retinopathy, neuropathy, macrovascular disease, atherosclerosis.

References1. International Diabetes Federation. (2009). Diabetes Atlas, Fourth Edition.2. Standards of medical care in diabetes. (2008). Diabetes Care; 31 Suppl 1:S12-54.3. WorldHealthOrganization/InternationalDiabetesFoundation.(2006).DefinitionandDiagnosisofDiabetesMellitusandIntermediateHyperglycemia:reportofaWorldHealth

Organization/InternationalDiabetesFoundationConsultation.Geneva,Switzerland:WHO Document Production Service: 1-46.

* Type 2 and 3 are accounting for 5% - 10% of all cases 1

** Type 3: In 2% - 5% of all pregnancies are women developing a third, usually temporary type of diabetes called gestational diabetes 1

Urisys® 1100 analyzerConnected, compact and intuitive

Designed for doctor’s office or ward.

Rule out your doubtsMinimize potential transcription errors through convenient data input via barcode reader

Simplify your lifeEliminate manual documentation through export of data over host connection

Be safePrevent unauthorized access and comply with accreditation requirements by an operator lock-out feature

Learn at your paceConduct self-trainings anytime with existing training CD (available in English, German and Spanish)

Peace and calmness for everyoneGuarantee friendly environment with quiet operations

Centralize initialization (cobas IT 1000 solution required)Change general instrument settings for several analyzers from a central area

COBAS, LIFE NEEDS ANSWERS, COMBUR-TEST and URISYS are trademarks of Roche.

©2010 Roche


Urisys® 1100 analyzerTechnical specifications

Instrument System Semi-automated urine test strip analyzer


Measuring system Wave lengths: 565 nm, 610 nm

Throughput Approx. 50 test strips/h (normal mode)Approx. 100 test strips/h (fast mode)

Memory 100 results

User interface Liquid Crystal Display (LCD), 2 lines of 24 characters

Printer Thermal printer

Certificates CE, UL, CUL

Physical dimensions

Width: 15.0 cmDepth: 29.0 cmHeight: 9.5 cm

Weight Approx. 0.8 kg

Strips* Urine test strips Combur Test® Strips

Parameters

Name SG pH LEU NIT PRO GLU KET UBG BIL BL

Combur 5 Test • • • • •Combur 7 Test • • • • • • •

Combur 10 Test UX • • • • • • • • • •Calibration Control-Test M calibration strip

Connectivity System interfaces 5-pin DIN socket for keyboard and barcode readerSerial interface to PC and host

Host protocols Unidirectional, bidirectional or ASTM (selectable)

Sample identification Sample ID via keyboard entry or barcode reader

Accessories Type Barcode reader, keyboard

Supported barcode types Code 39, Code 128, NW 7 (Codabar), ITF (Interleaved 2 of 5)

* Combur Test® strips are marketed under Chemstrip® in United States and Canada. Combur 7 Test® and Combur 5 Test® are not available in some countries.

Urisys® 2400 analyzerEfficient, reliable and convenient

Committed to the needs of laboratories with a throughput of more than 100 samples per day.

Stay flexibleAdjust easily to different workloads with continuous rack or batch loading. Streamline laboratory workflow with standard racks from Roche

Convenience you deserveIncrease walk-away time with a fully automated solution. Simplify interaction with one-grip and one-push loading of patented test strip cassette and sample rack as well as wash procedures similar to sample loading

Ease traceabilityCapture easily sample ID and standard rack ID with integrated barcode reader

Ensure qualityMaintain quality with fully automated wash procedures and QC due to definable control racks. Secure quality of test strips on-board up to two weeks in humidity safe cassette compartment

Do things the way you wantGain access to raw data for expert interpretation or customize reporting with the availability of flexible ranges and reflectance values

Influence spendingManage effectively your operational costs with a dry calibration concept in combination with calibration intervals of 4 weeks

COBAS, LIFE NEEDS ANSWERS and URISYS are trademarks of Roche.

©2010 Roche


Urisys® 2400 analyzerTechnical specifications

Instrument System Fully automated urine test strip analyzer


Measuring system

Wave lengths: 470 nm, 555 nm and 620 nmSpecial Gravity: Refractometer Clarity: Turbidimeter

Throughput Approx. 240 samples/h (75 samples = 15 racks/tray for 75 samples)

Minimum sample volume 1.5 mL

Liquid Handling 2 syringes, 1 needle, liquid level detection

Memory 1000 routine samples, 200 STAT samples, 300 control samples

User interface LCD color touch screen (118x89 mm / 4.6x3.5 inches)

Printer External printer

Certificates VDE, GS, UL, CE

Physical dimensions

Width: 53.0 cm (21 inches)Depth: 65.0 cm (25.6 inches)Height: 67.0 cm (26.4 inches)

Weight Approx. 85 kg (187 Am. pounds)

Strips Test strips Urisys® 2400 Cassette with 400 test strips

Parameters

pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, blood (erythrocytes/hemoglobin), color, (clarity, specific gravity)

Calibration Urisys® 2400 Calibration Strip

Connectivity System interfaces Serial interface RS 232 C to host; Parallel printer port

Host protocols Urisys® 2400 ASTM

Sample identification Via integrated barcode reader (supported barcode types: Code 39, Code 128, NW 7 {Codabar}, ITF {Interleaved 2 of 5})

Urinary tract infection (UTI)Frequency, urgency, and burning

Understand the importance of UTIsRemember that acute UTIs are among the most common reasons for which people seek medical advice. One woman in five develops a UTI during her lifetime.1 Optimisation of the diagnostic process can reduce morbidity and improve patient outcomes and satisfaction.

Keep it simple and safeBe aware of the practical value of urinalysis. Easy-to-use and sensitive test strips are a standard diagnostic tool and can detect about 90% of UTIs.5 Early diagnosis permits adequate treatment and thus prevents serious complications. Manage your timeTake advantage of urinalysis with quick and easy-to-use urine test strips with UTI-specific test pads for leukocytes, nitrite, and erythrocytes.2 On-site testing and even patient self-testing at home are possible and can detect bacteriuria, pyuria, and hematuria immediately.

Back up the clinical diagnosisDo not rely on clinical diagnosis alone. Instead, confirm the presence of uropathogens by means of urine test strips.2 These detect leukocyte esterase with a specificity of up to 98% and a sensitivity of up to 96%.3 Nitrite tests have a specificity of 95% and a sensitivity of up to 85%.4

Save money Bear in mind that healthcare costs associated with UTIs exceed a billion US dollars a year in the US alone. Advances in diagnosis can have a major economic impact.5 Combur urine test strips provide a cost-effective method of detecting UTI.

Avoid unnecessary antibiotic treatmentOptimise your diagnostic management by using Combur urine test strips to obtain a firm diagnosis. Avoid unnecessary antibi-otic treatment resulting from false-positive results and thereby reduce the risk of side effects and complications including the development of antibiotic resistance.


©2010 Roche


Urinary tract infection (UTI)Features

Definition Infection of any part of the urinary tract with pathogenic microorganisms.

Epidemiology Second most common type of infection after respiratory infections.6

One woman in five develops a UTI during her lifetime. UTIs in men are not as common as in women but can be very serious when they do occur. Uncomplicated UTIs are most common in young, sexually active women. UTIs affect up to 15% of women each year. More than 25% of women who have had a UTI will experience a recurrence.1 Most common causative agent of uncomplicated UTI (75–95%): Escherichia coli.5,7 Other important species: Proteus, Klebsiella.

Risk factors Anatomical or functional abnormalities of the urinary tract, immunosuppression or immunodeficiency, diabetes, pregnancy, history of cystitis, frequent or recent sexual activity, urological instrumentation, e.g. catheterisa-tion, etc.

Symptoms Dysuria, polyuria, urinary frequency, urinary urgency, suprapubic pain, hematuria. Fever, loin pain, nausea, and vomiting might indicate upper urinary tract infection (pyelonephritis).7,8

Diagnosis Urine test strips, bacterial load (significant bacteriuria: ≥ 105 organisms/mL usually indicates the presence of an infection), urine culture (with susceptibility testing), microscopic examination of the urine.The diagnosis of UTI is confirmed by detection of uropathogenic organisms in monoculture accompanied by leukocyturia. Counts of less than 105 organisms/mL do not rule out the presence of a UTI.

Therapy 5 Three-day course of double-strength TPM-SMX (trimethoprim-sulfamethoxazole) as empirical therapy.Fluoroquinolones are not recommended as first-line agents (resistance concerns).Treatment alternative: seven-day course of nitrofurantoin or a single dose of fosfomycin.Beta-lactams are not recommended.

References1. Car, J. (2006). Urinary tract infections in women: diagnosis and management in primary care. BMJ; 332:94-97.2. Stamm, W.E. (2008). Urinary tract infections, pyelonephritis, and prostatitis. In: Fauci AS, Braunwald E, Kasper DL, et al., eds. Harrison’s principles of internal medicine.

New York: Mc Graw Hill; 1820-18303. Hooton, T.M., Stamm, W.E. (1997). Diagnosis and treatment of uncomplicated urinary tract infection. Infect Dis Clin North Am; 11:551-581.4. Orenstein, R., Wong, E.S. (1999). Urinary tract infections in adults. Am Fam Physician; 59:1225-1234, 1237.5. Mehnert-Kay, S.A. (2005). Diagnosis and management of uncomplicated urinary tract infections. Am Fam Physician; 72:451-456.6. National Kidney and Urologic Diseases Information Clearinghouse http://www.kidney.niddk.nih.gov/, National Institute of Diabetes and Digestive and Kidney Diseases

http://www.niddk.nih.gov, National Institutes of Health http://www.nih.gov, NIH Publication No. 07–2097, December 2005.7. Nicolle, L.E. (2003). Urinary tract infection: traditional pharmacologic therapies. Dis Mon; 49:111-128.8. European urinalysis guidelines. (2000). Scand J Clin Lab Invest Suppl; 231:1-86.

Diagnosis algorithm 8

≥ 3 symptoms of UTI: dysuria, urgency, frequency, polyuria, haematuria, etc

Mild or ≥ 2 symptoms of UTI

Nitrite +, leucocyte +/-, protein +/-

Probable UTI

Treatment with first line agents

Nitrite -, leucocytes - protein -, blood -, NPV 95%

UTI very unlikely urethral syndrome probable

reassure, give advice on management symptoms

Nitrite -, leucocytes +

Review time of specimen UTI or urethral syndrome

Treat in case of severe symp-toms, send urine for culture

Consider other diagnosis

Nitrite -, leucocytes -, blood or protein +

No vaginal discharge or irritation

perform lipstick test with nitrite

Urine specimen

90% culture positive

Examine

Empirical antibiotic treatment,

no dipstick needed

Urine not cloudy, 91% negative culture,

NO TREATMENT

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