Medi-Test Brochure

Urine Analysiswith Test StripsURYXXON ® Relax – Fast, Standardized Urine AnalysisURYXXON ® 300 –Urine Analysis for Medium to High Sample ThroughputMedi-Testwww.mn-net.com2www.mn-net.comMN www.mn-net.com MNwww.mn-net.comMN www.mn-net.com MN- Quality made in Germany- Urine analysis since more than 25 years- Special pH papers for pharmaceutical industries- EN ISO 13485 and EN ISO 9001 certi?ed- MACHEREY-NAGEL commercial department in Düren, GermanyWe are pleased that you are interested in our high-quality medical test strips. This bro-chure gives a survey of the different products and applications in the ?elds of urine and blood analysis. MACHEREY-NAGEL – The companySince its foundation in 1911, the roots of MACHEREY-NAGEL are in the ?eld of high quality ?lter papers. Since the ?fties, we have developed ?lter papers into top quality test papers for laboratory use. Today, we offer the world’s largest selection of different test papers. Ad-ditionally, we offer a versatile programme of special products for analytical chemistry in the ?elds of chromatography, water analysis and bioanalysis.The production of our test strips, as well as our company headquarter, are located in Düren (Germany). Local sales of?ces for test strips are found in Switzerland, France and the US.MACHEREY-NAGEL – Medical test stripsSince the late seventies, MACHEREY-NAGEL produces high quality test strips for urine analysis. At that time, we were the fourth manufacturer of such test strips world-wide. In the meantime, we have continuously developed the chemistry of our test strips. We are proud that today customers in more than 70 countries enjoy the outstanding quality of our medical test strips.In addition, many pharmaceutical companies rely on MACHEREY-NAGEL. pH test strips manufactured by MN are used to monitor the dosing of different medications. We have gained the IVD application with CE certi?cation according to the IVD Directive 98/79/EC. MACHEREY-NAGEL – Certi?ed qualityAlready since 1996, MACHEREY-NAGEL is certi?ed according to EN ISO 9001. As a mat-ter of course, we are also certi?ed according to the Medical Devices Directive EN ISO 13485. Today we are among the few manufacturers who can offer urine test strips with CE certi?cation not only for professionals, but also for the patient self-testing.MACHEREY-NAGEL - The CompanyWelcome to MACHEREY-NAGELMACHEREY-NAGELFiltration · Testing · Chromatography · BioanalysisFiltrieren · Testen · Chromatographie · BioanalytikMNwww.mn-net.comMN www.mn-net.com MN3www.mn-net.comMN www.mn-net.com MNThe use of urine test strips is acknowl-edged as modern screening method in medical practice. With these non-invasive tests important information on the health status of the patient is rapidly obtained. The urine sample is easily drawn and can imme-diately be investigated with a test strip. Thus one obtains within minutes a result, which facilitates the decision for further diagnostic and therapeutic action. Only on pathological results for certain pa-rameters, a subsequent, e.g. microscopic, examination of the urine is necessary. If the test strip result is without pathologi-cal ? nding and the patient is not clinically conspicuous, further time- and cost-inten-sive investigations, can often be avoided. This saves considerable costs for the healthcare system and spares the patient unnecessary examinations.Urine test strips from MACHEREY-NAGEL are especially user-friendly. Due to the high resistance towards interferences by ascor-bic acid, a second testing for sensitive pa-rameters such as blood or glucose is un-necessary in most cases. The optimized, ? exible shape of the test strips also allows the examination of very small amounts of urine. This makes urinalysis reliable and easy.Urine Analysis with Test StripsUrine Analysis with Test Strips- Urine test strips offer a rapid survey of the health status of a patient- Urine chemistry – rapid and reliable- Flexible strip design for small volume urine samples- improves integrity of urine testing- Urine test for animals: rapid and easilyThe examination of the urine of small ani-mals (dogs, cats, rabbits, guinea pigs etc.) provides valuable information for the diagnosis of disorders and diseases of the urinary tract. Ideally, a urine sample should be obtained through cystocentesis. How-ever, the examination of spontaneous urine is often adequate for an initial diagnosis. First, all urine samples undergo a macro-scopic examination. The urine volume,colour, transparency and smell are evaluated.Using Medi-Test Combi 10® VET the urine status can easily be evaluated. The leaf-let describes characteristics of the in-dividual tests for the different species.This makes urine analysis of small ani-mals safe and easy.- rapid and easilyUrine test strips for animals – Combi 10® VETAdulteration is the intentional tamper-ing with a urine sample by the donor to avoid detection of illicit drug use. Successful adulteration produces a false-negative drug test result. An estimated 4% of all urine samples sub-mitted for drugs-of-abuse testing in the USA is adulterated. With the easy access of information from the internet, the number of adulterated specimen is increasing. Re-cently, urine adulteration has also become a problem in Europe.Classic adulterants include many com-monly available household substances like water, bleach, baking soda or vinegar. More recently, commercial adulterants became available with names like Urine Luck, Klear etc.. Medi-Test adulteration sticks reliably detect unusual levels of Creatinine, Nitrite, Glutar-aldehyde, pH, Speci? c Gravity and Oxidants generally connected with classical or com-mercial adulterants. Removing adulterated samples for drugs of abuse testing saves money and increases the integrity of the testing program.Easy detection of urine adulteration – Medi-Test Adulteration Stick4www.mn-net.com MNwww.mn-net.com MN?? ??????????????The URYXXON® Relax provides depend-able urine status results to detect early stages of many diseases such as diabetes, kidney disease and urinary tract infections. Instrument-read results have long proven to be advantageous for both, busy health care professionals and patients. URYXXON® Relax readings eliminate the subjectivity of visual colour interpretation. The compre-hensive interface options and the optimized printouts minimize risks associated with manual transcriptions. Reliable results can be obtained virtually immediate at the point of care.The URYXXON® Relax makes urinalysis simpler and more reliable.Technical speci? cationsCapacity· 50 strips/hInstrument memory· 200 patient test results including name or patient IDInterface· User: Touch screen display, alphanu- meric input, password protection· Computer: USB interface for connection to PC alternatively RS 232 interface for connection to PC and PS/2 interface for connection of keyboard and/or barcode readerPower requirements· 110-240 V AC, automatic · Battery powered operation (optional) with 6 AA batteriesDimensions / Weight· Depth: 20 cm (8 inches) · Width: 16 cm (6 inches)· Height: 7.5 cm (3 inches) · Weight: 710 g (1.90 lb) (without batteries and power supply)Operation· Temperature range: 5-40 °C (41 °F-104 °F)· Humidity range: 20-80% relative humid- ity, non condensing · Calibration: automatic, self-calibratingURYXXON ® RelaxURYXXON® Relax – automated urinalysis at the point of care- 50 measurements/h- Evaluation software- high precision optic- Medi-Test URYXXON® Stick 10www.mn-net.com MN5www.mn-net.com MN?? ??????????????The URYXXON® 300 Instrument has been designed for the ef?cient and rapid reading of urine test strips URYXXON® Stick 10. With a high throughput of 1 strip every 8 seconds (400/h), the reader is ideal for medium to large laboratories.The instrument ?ags all positive results and can be con?gured to report only positive samples if necessary. This allows for the quick identi?cation of pathological samples and of patients in need of further care. Due to the self-explanatory menu the instrument is very user friendly and easy to operate.The URYXXON® 300 can be operated with barcoded samples and can easily be con-nected to existing laboratory information systems via RS 232 interface.Technical Speci?cations:Capacity· 400 strips/hInstrument memory· 500 measurements with ID and date, 20 calibration measurementsInterfaces:· RS 232, unidirectional or bidirectional to host· PS/2 for the connection of barcode reader and/or keyboardPower requirements· external mains adaptor· 110-240 V, 50/60 Hz, 24 WDimensions / Weight· 240x280x150 mm (DxWxH)· Weight: approx. 4 kgURYXXON ® 300URYXXON® 300 – high performance urinalysis- 400 measurements/h- easy to use- small footprint- Medi-Test URYXXON® Stick 106www.mn-net.comMN www.mn-net.com MNwww.mn-net.comMN www.mn-net.com MNSigni?cance of the parametersUrine test strips are indispensable tools in medical diagnostics to gain a rapid survey of the state of health of a patient.The medical context of urine parametersBlood: Serious infections of the kidneys and urinary tract, urolithiasis, suspected renal or bladder neoplasmsUrobilinogen: Acute and chronic liver parenchyma damage, hemolytic jaundice, pathological state of the intestinal tractBilirubin: Liver parenchyma damage, obstructive jaundice (also for indicating biliary obstructions)Protein: Symptomatic of renal and urinary tract diseasesNitrite: Bacterial infection of kidneys or urinary tractKetones: Metabolic abnormalities, indication of ketoacidosisGlucose: Early detection and supervision of diabetes mellituspH: Useful in relation to other parameters Specific gravity: Concentration ability of kidneys, supplement for other parametersLeukocytes: Symptomatic of inflammatory renal and urinary tract diseasesDiabetes mellitus with test fields for Glucose, KetonesLiver and bile with test fields for Bilirubin, UrobilinogenKidneys and urinary tract diseases with test fields for Protein, Blood, Leukocytes Nitrite, Specific gravity, pH valueParameters of the Combi 10® SGLThe test pads for Glucose and Blood have the best available protection against interferences caused by vitamin C (ascor-bic acid). This ensures correct results also when fruit juice or vitamin tablets are consumed. Eating restrictions do not apply. The excretion of vitamin C is harmless in itself. However, vi-tamin C interferes with important oxidation reactions. With many test strips this leads to false negative readings for blood and glucose.The Medi-Test technology overcomes the in?uence of vita-min C. This ensures optimal and safe results for all important urine parameters. 1)Test strips that already feature the optimal protection against ascorbic acid are marked in the ordering information.Best available vitamin C protection1)50403020100 MN R B D YBlood(10 mg/dl)4003002001000 MN R B D YGlucose(100 mg/dl)Concentration of vitamin C in the sample, with no effect on the results for blood and glucose in urine (mg/dl)www.mn-net.comMN www.mn-net.com MN7www.mn-net.comMN www.mn-net.com MNPrinciple, Evaluation, Sources of error, Diagnosis of test ?eld parameters GlucosePrinciple: The detection is based on the glu-coseoxidase-peroxidase-chromogen reation. The oxidation of glucose by atmospheric oxygen is catalyzed by glucoseoxidase to form gluconic acid lactone and hydrogen peroxide. Peroxidase catalyzes the reaction of hydrogen peroxide with the chromogen. Apart from glucose, no other compound in urine is known to give a positive reaction. Evaluation: Pathological glucose concen-trations are indicated by a colour change from green to bluish green. Yellow or green-ish test ?elds should be considered nega-tive or normal. All test ?elds which have an intensity greater than the greenish nega-tive colour ?eld must be considered posi-tive. The colour ?elds correspond to the fol-lowing ranges of glucose concentrations: neg. (yellow), neg. or normal (greenish), 50, 150, 500 and =1000 mg/dl or neg. (yellow), neg. or normal (greenish), 2.8, 8.3, 27.8 and =55.5 mmol/l. An inhibitory effect is produced by gentisic acid. Falsely posi-tive reactions can also be produced by a residue of per-oxide-containing cleansing agents. For test strips that already feature the optimal protection against ascorbic acid, the glucose test is not in?u-enced by vitamin C. These strips are marked in the ordering information. Other test strips may show false negative results with larger amounts of ascorbic acid in the sample.Diagnosis: Because of the clear distinc-tion between physiological and pathological glucosuria, the test is especially suitable for the detection of diabetes mellitus and for su-pervising (and self-supervising) of diabetes. Apart from diabetes mellitus, renal glucosuria with increased glucose concentrations may be noted during pregnancy, and after a meal with excessive carbohydrates. Every positive test reaction requires further diagnosis.Medical parameterspH valuePrinciple: The test paper contains indicators, which clearly change colour between pH 5 and pH 9 (from orange to green to turquoise).Evaluation: The pH value of fresh urine from healthy people varies between pH 5 and pH 6. The colour scale gives a clear distinction of pH value between pH 5 and pH 9. The pH should always be measured in fresh urine, since bacterial decomposition may increase the pH of the urine to values > 9.Diagnosis: The pH value is only of signi?-?cance in relation to other parameters. More acid urine (lower pH values) is found in case of an increased protein metabolism, high fever, serious diarrhoea and metabolic acidosis (serious form of diabetes mellitus). Alkalinity (increased pH value) may be noted in urinary tract infections, respiratory or metabolic alka-losis.- Early detection of diabetes mellitus- Supervision of type-II-diabetics- Diseases of the urogenital tract- Supplement for other parameters- Backup for microscopic results- Early detection of ketosis / acidosis- Control-parameter for Diabetes mellitusKetonPrinciple: The test is based on the principle of Legal`s test. Acetoacetic acid and acetone form a violet coloured complex with sodium nitroprusside in alkaline medium.Evaluation: Acetoacetic acid reacts more sensitively than acetone. Values of 10 mg/dl of acetoacetic acid or 50 mg/dl acetone are indicated. The colour ?elds correspond to the following acetoacetic acid values:0 (negative),25 (+), 100 (++) and 300 (+++) mg/dlor0 (negative)52.5 (+), 10 (++) and 30 (+++) mmol/l.Phenylketones in higher concentrations inter-fere with the test, and will produce deviating colours. ß-hydroxybutyric acid (not a ketone) is not detected. Phthalein compounds inter-fere by producing a red colouration.Diagnosis: Ketone bodies including acetoace-tic acid, acetone, and ß-hydroxybu-tyric acid are only produced in the liver. Ketones in the urine are caused by an abnormal carbo-hydrate metabolism. Frequently, ketonuria is a sign of diabetic ketosis, which in connection with other metabolic abnormalities may cause diabetic coma. Ketonuria may also be noted in case of insulin overdoses, starvation (e.g. slimming diet, calorie free diet), dangerous metabolic abnormalities during pregnancy (Hyperemesis gravidarum), acetonemic vomiting of infants and fever caused espe-cially by infections.8www.mn-net.comMN www.mn-net.com MNwww.mn-net.comMN www.mn-net.com MN- Symptomatic of renal and urinary tract diseases- Symptomatic for renal and urinary tract infectionsMedical parametersProteinPrinciple: The test is based on the „protein error“ prin-ciple of indicators. The test zone is buffered to a con-stant pH value and changes colour from yellow to greenish blue in the presence of albumin. Other proteins are indicated with less sensitivity.Evaluation: The test strip detects values above 10 mg protein/dl urine. The colour ?elds cor-respond to the following ranges of albumin concentrations:negative, 30, 100 and 500 mg/dl ornegative, 0.3, 1.0 and 5.0 g/l.Falsely positive results are possible in strongly alkaline urine samples (pH > 9), after infusions with polyvinylpyrrolidone (blood substitute), af-ter intake of medicaments containing quinine, and also by disinfectant residues in the urine sampling vessel. The protein colouration may be masked by the presence of medical dyes (e. g. methylene blue) or beetroot pigments.Diagnosis: The limit of a physiological protein-uria lies between 10 and 30 mg/dl. It differenti-ates between:1) Benign proteinuria is observed after phys-ical strain, orthostatic proteinuria, with fever and during pregnancy. In such cases the pro-tein excretion rate is usually normal in the ?rst morning urine, however in the course of the day values can vary greatly.2) Extrarenal proteinuria frequently appears with acute diseases like heart insuf?ciency, colics, liver cirrhosis, plasmocytoma, and car-cinomas.3) Renal proteinuria is caused by increased permeability of the glomerular ?lter and may indicate pyelonephritis, glomerulonephritis, tuberculosis of the kidneys, kidneys participa-tion at infections and poisonings, cystic kid-neys, gouty kidney. Every positive test reac-tion requires further diagnostic examinations.LeukocytesPrinciple: The test is based on the es-terase activity of granulocytes. This enzyme splits a car-boxylic acid ester. The alcohol com-ponent formed during this step reacts with a diazonium salt to form a violet dye.Evaluation: The test detects values from about 10 to 25 leukocytes/l urine. Discolourations, which can no longer be correlated to the neg-ative test ?eld, and weakly violet discoloura-tions after 120 seconds are to be considered positive. The colour ?elds correspond to the following leukocyte concentrations:negative (normal), 25, 75, 500 leukocytes/µlA diminished reaction can result for protein excretion above 500 mg/dl, and a glucose concentration above 2 g/dl as well as during therapy with preparations containing cepha-lexin or gentamycin. Bacteria, trichomonades and erythrocytes do not give a positive reac-tion with this test. Formaldehyde (a preser-vative) can cause falsely positive reactions. Excretion of bilirubin, nitrofurantoin, or other strongly coloured compounds can cover the reaction colour. For samples from female patients vaginal secretion can simulate a falsely positive re-action. In order to avoid falsely positive re-sults, the urine should only be sampled after thorough cleaning of the genitals.Diagnosis: An increased excretion of leuko-cytes in urine (leukocyturia) is an important symptom for infectious diseases of the kid-neys and/or urinary tract (incl. the prostate). Leukocyturia is especially important for diag-nosis of chronic pyelonephritis. Often it is the only symptom between acute attacks.Other causes for leukocyturia may be:analgetic nephropathia, glomerulopathia and intoxications, cystitis, urethritis, kidney or uro-genital tuberculosis, fungus and trichomonade infections, gonorrhoea, urolithiasis, tumors with obstructions.BloodPrinciple: The detec-tion is based on the pseudoperoxidative activity of hemoglo-bin and myoglobin, which catalyze the oxidation of an indi-cator by an organic hydroperoxide, producing a green colour.Evaluation: The minimum sensitivity of the test strip is 5 to 10 erythrocytes/µl urine cor-responding to approx. 0.015 mg hemoglobin or myoglobin/dl urine. Intact erythrocytes are indicated by ?ecked discolourations of the test ?eld. The colour ?elds correspond to the following values:0 (negative), ca. 5-10, ca. 50, ca. 250 Ery/µl,or a hemoglobin concentration out of ca. 10, ca. 50, ca. 250 Ery/µl.www.mn-net.comMN www.mn-net.com MN9www.mn-net.comMN www.mn-net.com MN- Serious detection of the kidneys and urinary tract urolithiasis, suspend renal or bladder neoplasms- Bacterial infection of the kidneys or urinary tract- high concentrations may disturb other test ?eldsand by very low nitrate concentrations in urine as the result of low nitrate diet or strong dilution (diuresis). Falsely positive re-sults can be caused by the presence of diagnostic or thera-peutic dyes in the urine.Diagnosis: Bacteria, which cause infections, and can produce nitrite in the urine are e. g. E. coli (bacteria which causes most frequently in-fections), Aerobacteria, Citrobacteria, Klebsi-ella, Proteus, Salmonellae and in part Entero-cocci, Pseudomonas and Staphylococci. If the test is positive a microscopic examination and determination of susceptibility of pathogenic bacteria to chemotherapeutic agents should follow.Medical parametersThe blood test on Medi-Test urine test strips is opti-mally protected against interferences by ascorbic acid. Even with 40 mg/dl of ascorbic acid the tests provide safe results. Only for Combi 11 ascorbic acid in the sample may lead to false negative readings. For Combi 10® SGL and URYXXON® Stick 10 normal concentrations of ascorbic acid (< 40 mg/dl) do not in?uence the test result. However gentisic acid still shows an inhibitory ef-fect. Falsely positive reactions can be produced by a residue of peroxide-containing cleansing agents. Diagnosis: Every positive reaction should be taken as a pathological ?nding requiring further diagnos-tic examinations. Hematuria (hemolysis of intact erythrocytes occurs on the test ?eld), hemoglobin-uria or myoglobinuria are frequently caused by:Serious infections of the kidneys and urinary tract, kidney and bladder calculi, serious poisonings (e. g. benzene and aniline derivatives, chlorate, bacteria toxins, poisonous mushrooms and snake poison), heart attack, hemolysis after transfusion incident, cold hemoglobinuria or march hemoglo-binuria (after strong physical exertion), different paroxysmal hemoglobinurias and serious hemo-lytic anemias.NitritePrinciple: Microorganisms, which are able to reduce nitrate to nitrite, are indicated indirectly with this test, which is based on the principle of Griess reagent. The test paper contains an amine and a coupling component. Diazotiza-tion and subsequent coupling result in a red coloured azo compound. Only nitrite can pro-duce a diazonium salt for coupling reaction, therefore falsely positive results are virtually impossible in this case.Evaluation: The test detects concentrations from 0.05 to 0.1 mg nitrite/dl urine. Any pink colour indicates a bacterial infection of the uri-nary tract. The colour intensity only shows the nitrite concentration, and does therefore not provide information about the extent of the in-fection. A negative result does not preclude an infection of the urinary tract, if bacteria, which cannot produce nitrite are present. Falsely negative results can be produced by high doses of ascorbic acid, by antibiotics therapy, Ascorbic acid (Vitamin C)Modern Medi-Test urine test strips have the best available protection against in?uences of ascorbic acid (vitamin C) in the sample. For his-toric reasons, many test strips still feature a test pad for ascorbic acid. All test strips that already have the optimal protection against ascorbic acid are marked in the ordering information.Principle: The detection is based on the de-colouration of Tillman‘s reagent. The blue co-loured 2,6-dichlorophenol indophenol sodium salt is reduced to the colourless leuco form by ascorbic acid. In the presence of ascorbic acid a colour change takes place from blue to red.Evaluation: The colour ?elds correspond to the following values:0 (negative), 10 (+) and 20 (++) mg/dIor0 (negative), 0.6 (+) and 1.1 (++) mmol/I.Ascorbic acid may lead to false negative re-sults for glucose and blood. Therefore, the glucose and blood test must be repeated on positive ?ndings for ascorbic acid, however, at the earliest 10 hours after the last vitamin C intake.Please note: For URYXXON® Stick 10 and Combi 10® SGL normal concen- trations of ascor-bic acid (< 40 mg/dl) do not in-terfere, with the tests of blood and glucose.Diagnosis: The wide spread intake of ascorbic acid (e.g. in vitamin C therapy, as a therapeutical ingredient and stabilizer of numerous medica-ments, oxidation inhibitors and preservatives in food industry) causes a rapid saturation of the organism, and a renal excretion of the excess. Interfering ascorbic acid concentrations may be reached after the ingestion of fruit juice or plenty of fruit. Therefore, the ascorbic acid test zone minimizes falsely negative results. As with glucose detection, blood detection is also disturbed by low concentrations of ascor-bic acid, whereas high ascorbic acid concen-trations interfere with the nitrite and bilirubin test zones.10www.mn-net.comMN www.mn-net.com MNwww.mn-net.comMN www.mn-net.com MNMedical parametersUrobilinogenPrinciple: The test paper contains a stable diazonium salt producing a reddish azo com-pound with urobi-linogen.Evaluation: Depending on the urine colour 0.5 to 1 mg urobilinogen/dI urine are indicated. 1 mg/dl is considered to be the normal ex-cretion rate. Higher values are pathological. A complete absence of urobilinogen in the urine, which is likewise pathological, cannot be detected with the strips. The colour ?elds correspond to the following urobilinogen con-centrations:normal (0 - 1), 2, 4, 8,12 mg/dlornormal (0 - 17), 34, 70,140, 200 µmol/l.The test is inhibited by higher concentrations of formaldehyde. Longer exposure of the urine to light leads to lowered or falsely negative re-sults. Higher, or falsely positive results, can be caused by the presence of diagnostic or therapeutic dyes in the urine. Larger amounts of bilirubin produce a yellow colouration.Diagnosis: An increased urobilinogen con-centration in urine is a sensitive index of liver dysfunction or hemolytic diseases. Urobi-linogenuria is caused by e. g. virus hepatitis, chronic hepatitis, liver cirrhosis, infections, poisonings, congestion or carcinoma of liver, hemolytic, and pernicious anemina, polycy-themia and pathological state of the intestinal tract with an increased resorbence.- detection of liver diseases- in combination with Bilirubin differentiation between different forms of jaundice- detection of liver diseases - in combination with Urobilinogen differentiation between different forms of jaundice- Indication of the status of the kidney- Information about the state of hydrationSpeci?c gravity (Density)Principle: The test indicates the ion concentration of urine with good correlation to the r e f r a c t o m e t r i c method. Increasing ion concentrations cause a colour change from blue-green via green to yellow.Evaluation: The test allows determination of the urine density between 1.000 and 1.030. The normal value for adults with normal intake of food and liquid is from about 1.015 to 1.025; however, it can vary between 1.000 after extreme liquid intake, and 1.040 after a longer period of thirst. The density measured with test strips can vary slightly from value determined with other methods, since density increases due to glucose concentrations >1000 mg/dl (>56 mmol/l) are not covered. Increased protein excretion can result in density values, which are too high. Alkaline urines, with high contents of buffer substances, often show results, which are too low.Diagnosis: In kidney diagnostics determination of the urine concentration is important for checking the function of the kidney parenchyma. If high liquid intake is excluded, a very dilute urine can indicate a substantial insuf?ciency of the kidneys, and also a lowered ability of the kidneys to concentrate the urine, which may result from Diabetes mellitus, Diabetes insipidus, Hyperaldosteronism, in?uence of diuretic drugs.The density of the urine yields valuable supplementary information for the evaluation of other test strip parameters, and thus helps to avoid misinterpretations, especially:? during lysis of leukocytes and erythrocytes for interpreting possible differences with the sedimentation results? for evaluation of the test ?elds for nitrite, protein and glucoseEspecially in the intermediate range, between physiological and pathological results, the urine density can play the decisive role.BilirubinPrinciple: A red azo compound is obtained in the presence of acid by the coupling of bilirubin with a dia-zonium salt.Evaluation: The minimum sensitivity of the test strip is 0.5 to 1 mg bilirubin/dI urine. The co-lour ?elds correspond to the following values:o (negative), 1 (+), 2 (++), 4 (+++) mg/dlor0 (negative), 17 (+), 35 (++), 70 (+++) µmol/l.Some urine components can produce a yellow colouration of the test strip. Ascorbic acid and nitrite in higher concentrations inhibit the test. Longer exposure of the urine to light leads to lowered, or falsely negative results. Higher, or falsely positive results can be caused by the presence of diagnostic or therapeutic dyes in the urine.Diagnosis Only conjugated (water soluble) bilirubin is excreted by the kidneys. Normally bilirubin is undetectable in urine. Bilirubinuria generally indicates liver parenchyma damage (e. g. acute virus hepatitis and other forms of hepatitis, liver cirrhosis, toxic liver cell dam-age) or biliary obstructions (e. g. cholangitis, obstructive jaundice).Unconjugated bilirubin, which is detectable in serum, indicating hemolytic jaundice is not excreted by the kidneys and is absent from urine.www.mn-net.comMN www.mn-net.com MN11www.mn-net.comMN www.mn-net.com MNBlood test strips GlycaemieTest strips GlycaemieApplication: Orienting supervision of the blood-glucose concentration for diabetics and suspected diabetics and patient self-testing.Principle: Detection is based on the glucose-oxidase-peroxidase reaction and reacts spe-ci? cally to glucose. Evaluation: Visual evaluation by comparison with the colour scale. Normal concentrations (fasting blood sugar) vary between 70 and 120 mg/dl (3.9 - 6.7 mmol/l).Both hyperglycemia and hypoglycemia can be determined with this test. If the test results vary slightly from normal values, a quantita-tive (e.g. photometric) test should be carried out. Instructions for use:1. Open container. Remove one test strip. Do not touch the reaction zone3. After exactly 60 seconds wipe off the blood sample. Glycaemie C is unsuitable for monitoring neo-natal blood specimen.Laymen studies have shown that 95 % of all read-ings have been assigned to the correct colour ? eld. 3 % of the readings showed a falsely positive result, only 2 % of all readings were falsely negative. 2. Apply a good sized drop of blood to the test ? eld. >240 mg/dl: 180 s4. After 120 s (if values are over 240 mg/dl after 180 s) compare test ? elds with the colour scale. 216560 s47 60 s120 s1 23 40 100 200 300 400 500 6000100200300400500 ideal value+15 %-15 %Comparison of the results for Glycaemie C with labor methodGlycaemie C (photometric evaluation)ReferenceMN600MACHEREY-NAGEL – more than 25 years experience in medical test stripsMACHEREY-NAGEL GmbH & Co. KG · Neumann-Neander-Str. 6-8 · D-52355 DürenFrance:MACHEREY-NAGEL EURLTel.: +33 (0) 3 88 68 22 68Fax: +33 (0) 3 88 51 76 88e-mail: sales-fr@mn-net.comSwitzerland:MACHEREY-NAGEL AGTel.: +41 (0) 62 388 55 00Fax: +41 (0) 62 388 55 05e-mail: sales-ch@mn-net.comGermanyand international:Telefon: +49 (0) 24 21 96 90Fax: +49 (0) 24 21 96 91 99e-mail: sales-de@mn-net.comMNMACHEREY-NAGELwww.mn-net.comMACHEREY-NAGELZERTIFIZIERT NACHEN ISO 13485:2003MNMACHEREY-NAGELEN ISO 13485:2003CERTIFIEDMN USA:MACHEREY-NAGEL Inc.Tel.: +1 484 821 09 84Fax: +1 484 821 12 72e-mail: sales-us@mn-net.comMedi-Test ordering informationMedical-diagnostic test strips for urine analysisTest strips for semi-quantitative determination of glucose in blood (capillary blood)FlyUrine&Blood en6/1/0/10.07 PDKATEN100017Printed in Germany REF REF Medi-Test type with test ? elds for determination of 50 100 strips strips per per pack pack 930 01 930 24 Glucose1) • 930 03 930 26 Glucose 31) • • • 930 04 930 27 Protein 21) • • 930 05 930 28 Keton1) • 930 06 930 29 Nitrit1) • 930 12 930 33 Urbi • • 930 15 930 37 Combi 21) • • 930 07 930 30 Combi 3 A® • • • • 930 09 930 32 Combi 54) • • • • • 930 35 930 36 Combi 5 N® 4/5) • • • • • • 930 55 – Combi 5 S4/5) • • • • • 930 18 930 78 Combi 64) • • • • • • 930 13 930 34 Combi 6 A4) • • • • • • • 930 10 930 22 Combi 74) • • • • • • • – 930 21 Combi 8 L4/5) • • • • • • • • 930 11 930 23 Combi 9® 4) • • • • • • • • • – 930 56 Combi 10® 4) • • • • • • • • • • 930 79 930 58 Combi 10® L4) • • • • • • • • • • – 930 60 Combi 11 • • • • • • • • • • • 930 77 930 67 Combi 10® SGL4/5) • • • • • • • • • • – 930 68 URYXXON® Stick 102/4) • • • • • • • • • •Test strips for veterinary applications – 930 870 Combi 10® VET3) • • • • • • • • • • Test strips for detection of urine adulteration 930 19 – Medi-Test Adulteration Stick3) • • • • • • All products are CE-marked according to the directive 98/79/EC1) suitable for patient self-testing 2) for evaluation with URYXXON® re? ectometers 3) not an IVD product4) optimal protection of the blood test against ascorbic acid 5) optimal protection of the glucose test against ascorbic acid Instruments for evaluation of urine test strips URYXXON® Stick 10 930 88 URYXXON® Relax, automated urinalysis at the point of care 930 69 URYXXON® 300, high performance automated urinalysisAccessories and spare parts 930 65 Printer paper for URYXXON® Relax, Pack of 5 rolls 930 890 Strip adaptor for URYXXON® Relax 930 891 PC-software pack for URYXXON® Relax 930 71 Printer paper for URYXXON® 300, Pack of 5 rolls 930 72 PC-software pack for URYXXON® 300 930 74 Barcode scanner for URYXXON® 300 and URYXXON® RelaxBlutzucker-Teststreifen 928 07 Test strips Glycaemie C (bicolored) for visual determination, pack of 50 test strips1) 928 12 Test strips Glycaemie V for visual determination, pack of 50 test strips1)GlucoseKetonesAscorbic acidProteinBloodLeukocytesNitriteSpeci? c GravitypH valueBilirubinUrobilinogenCreatinineGlutaraldehydeOxidants