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5'-tetramethyl-benzidine and buffered organic peroxide. The resulting colors range from orange to yellow-green and dark green. Very high blood concentration may cause the color development to continue to dark blue.

pH: This test is based on the well known double pH indicator
method, where bromothymol blue and methyl red give distinguishable colors over the pH range of 5-9. The colors range from red-orange to yellow and yellow-green to blue-green.
Protein: This test is based on the protein error-of-indicator
U r in e T e sts
principle. At a constant pH, the development of any green color is due to the presence of protein. Colors range from yellow for a U r in e a n a ly sis str ip s
"Negative" reaction to yellow-green and green to blue-green for a
"Positive" reaction.

Urobilinogen: This test is based on a modified Ehrlich reaction in
which p-diethylaminobenzaldehyde reacts with urobilinogen in a
strongly acid medium. Colors range from light pink to bright
magenta.
For in vitro Diagnostic Nitrite: This test depends on the conversion of nitrate to nitrite by
the action of Gram-negative bacteria in the urine. The nitrite reacts with p-arsanilic acid to from a diazonium compound in an acid For the semi-quantitative and qualitative detection of Glucose, medium. The diazonium compound in turn couples with 1,2,3,4- Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, tetrahydrobenzo(h) quinolin to produce a pink color. Urobilinogen, Nitrite,and Leukocytes in urine. Leukocytes: This test is based on the action of esterase present in
leukocytes, which catalyzes the hydrolysis of an indoxyl ester Urine Strips for Urinalysis are firm plastic strips to which several derivative. The indoxyl ester liberated reacts with a diazonium salt different reagent areas are affixed. Depending on the product being to produce a beige-pink to purple color. used, Urine Strips provide tests for Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, REAGENTS
Urobilinogen, Nitrite and Leukocytes in Urine. Test results may (Based on dried weight at time of impregnation)
provide information regarding the status of carbohydrate
Glucose: 16.3%w/w glucose oxidase (Aspergillus niger, 1.3IU);
metabolism, kidney and liver function, acid-base balance, and 0.6%w/w peroxidase (horseradish, 3300 IU); 7.0% w/w potassium bacteriurea.1,2 Please refer to the outside box and bottle label for the iodide; 76.1% w/w buffer and non-reactive ingredients. specific test parameters of the product you are using. Bilirubin: 0.4% w/w 2,4-dichloroaniline diazonium salt, balanced
Urine Strips are packaged along with a drying agent in a plastic with buffer and non-reactive ingredients. bottle with a twist-off cap. Each strip is stable and ready to use upon removal from the bottle. The entire reagent strip is disposable. Ketone: 7.7% w/w sodium nitroprusside balanced with buffer and
Results are obtained by direct comparison of the test strip with the non-reactive ingredients. color blocks printed on the bottle label. No calculations or laboratory instruments are required. Specific Gravity: 2.8% w/w bromothymol blue, 69.0%; poly
(methyl vinyl ether/maleic anhydride); 28.2% sodium TEST PRINCIPLE

Glucose: This test is based on a double sequential enzyme reaction.
One enzyme, glucose oxidase, catalyzes the formation of gluconic Blood: 6.6% w/w cumene hydroperoxide; 4.0% w/w 3, 3', 5, 5'-
acid and hydrogen peroxide from the oxidation of glucose. A tetramethylbenzidine; 89.4% w/w buffer and nonreactive second enzyme, peroxidase, catalyzes the reaction of hydrogen peroxide with potassium iodide chromogen to oxidize the chromogen to colors ranging from blue-green to greenish-brown pH: 0.2% w/w methyl red; 2.8% w/w bromothymol blue; 97% w/w
through brown and dark brown. nonreactive ingredients. Protein: 0.3% w/w tetrabromophenol blue; 99.7% w/w buffer and
Bilirubin: This test is based on the coupling of bilirubin with a
nonreactive ingredients. diazotized dichloroaniline in a strongly acid medium. The colors range from light tan to reddish-brown. Urobilinogen: 2.9% w/w p-diethylaminobenzaldehyde balanced
with buffer and nonreactive ingredients. Ketone: This test is based on the reaction of acetoacetic acid with
sodium nitroprusside in a strongly basic medium. The colors range Nitrite: 1.4% w/w p-arsanilic acid, balanced with buffer and
from beige or buff-pink color for a "Negative" reading to pink and nonreactive ingredients. pink-purple for a "Positive" reading. Leukocytes: 0.4% w/w indoxyl ester derivative; 0.2%w/w
Specific Gravity: This test is based on the apparent pKa change of
diazonium salt; 99.4% w/w buffer and nonreactive ingredients. certain pretreated polyelectrolytes in relation to the ionic concentration. In the presence of an indicator, the colors range from WARNINGS AND PRECAUTIONS
dark blue or blue-green in urine of low ionic concentration to green Urine Strips are for in vitro diagnostic use.Do not touch test areas and yellow-green in urine of higher ionic concentration. of Urine Strips.
Blood: This test is based on the pseudoperoxidase action of
hemoglobin and erythrocytes which catalyzes the reaction of 3,3', 5,
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improbable in screening. The reactivity of the glucose test decreases as the SG and/or ascorbic acid of the urine increases. Reactivity may also vary with temperature.3 Store at room temperature between 15°-30°C (59°-86°F) and out of Bilirubin: Reactions may occur with urine containing large doses
direct sunlight. Do not use after expiration date. of chlorpromazine or rafampen that might be mistaken for positive bilirubin.3 Indican (indoxyl sulfate) and metabolites of Lodine RECOMMENDED HANDLING PROCEDURES
may cause false positive or atypical color; ascorbic acid (25mg/dL All unused strips must remain in the original bottle. Transfer to any or greater) may cause false negative results. container may cause reagent strips to deteriorate and become nonreactive. Do not remove desiccant from bottle. Do not open Ketone: Color reaction that could be interpreted as "positive" may
container until ready to use. Opened bottles should be used within 3 be obtained with urine specimens containing MESNA or large months after first opening. amounts of phenylketones or L-dopa metabolites.3 SPECIMEN COLLECTION AND PREPARATION
Specific Gravity: The chemical nature of the specific gravity test
Collect urine in a clean container and test as soon as possible. Do not may cause slightly different results from those obtained with the centrifuge. The use of urine preservatives is not recommended. If specific gravity methods when elevated amounts of certain urine testing cannot be performed within one hour after voiding, refrigerate constituents are present. Highly buffered alkaline urine may cause the specimen immediately. Allow refrigerated specimen to return to low readings relative to other methods. Elevated specific gravity room temperature before testing. readings may be obtained in the presence of moderate quantities (100-750 mg/dl) of protein. TEST PROCEDURE
1. Remove from the bottle only enough strips for immediate use and Blood: The sensitivity of the blood test is reduced in urine with
replace cap tightly. high specific gravity and/or high ascorbic acid content. Microbial 2. Completely immerse reagent areas of the strip in fresh, well-mixed peroxidase, associated with urinary tract infection may cause false urine. Remove the strip immediately to avoid dissolving out the positive reactions. 3. While removing, touch the side of the strip against the rim of the pH: If proper procedure is not followed and excess urine remains
urine container to remove excess urine. Blot the lengthwise edge on the strip, a phenomenon known as "running over" may occur, in of the strip on an absorbent paper towel to further remove excess which the acid buffer from the protein reagent area run onto the pH urine and avoid running over (contamination from adjacent reagent area, causing a false lowering in the pH result. 4. Compare each reagent area to its corresponding color blocks on Protein: False positive results may be obtained with highly alkaline
the color chart and read at the times specified. Proper read time is urine. Contamination of the urine specimen with quarternary critical for optimal results. ammonium compounds may also produce false positive results.4 5. Obtain results by direct color chart comparison. Urobilinogen: The test area will react with interfering substances
known to react with Ehrlich's reagent, such as porphobilinogen and
p-aminosalicyclic acid.3 This test is not a reliable method for the
detection of porphobilinogen. Drugs containing azo-dyes (e.g. Azo
Gantrisin) may give a masking golden color. The absence of
urobilinogen cannot be determined with this test.
Nitrite: The pink color is not quantitative in relation to the number
Note: All reagent areas except Leukocytes may be read between 1-2 of bacteria present. Any degree of pink coloration should be minutes for screening positive urine from negative urine. Changes in interpreted as a positive nitrite test suggestive of 105 or more color after 2 minutes are of no diagnostic value. organisms/ml. There are occasional urinary tract infections from organisms, which do not contain reductase to convert nitrate to QUALITY CONTROL
For best results, performance of reagent strips should be confirmed by testing known negative and positive specimens or controls whenever a Leukocytes: Highly colored urine and the presence of the drugs
new test is performed or whenever a new bottle is first opened. Each cephalexin (Keflex) and gentamicin have been found to interfere laboratory should establish its own goals for adequate standards of with this test. High urinary protein of 500 mg/dl or above performance, and should question handling and testing procedures if diminishes the intensity of the reaction color. Elevated glucose these standards are not met. concentration or high specific gravity may cause decreased results. EXPECTED VALUES
Results are obtained by direct comparison of the color blocks printed on Glucose: Small amounts of glucose are normally excreted by the
the bottle label. The color blocks represent nominal values; actual kidney.5 Concentrations as little as 0.1 g/dl glucose, read either at 10 values will vary around the nominal values. or 30 seconds, may be significantly abnormal if found consistently. At 10 seconds, results should be interpreted qualitatively; for semi- LIMITATIONS OF PROCEDURE
quantitative results, read at 30 seconds only. Comparison to the color chart is dependent on the interpretation of the individual. It is therefore, recommended that all laboratory personnel Bilirubin: Normally, no bilirubin is detectable in urine by even the
interpreting the results of these strips be tested for color blindness. most sensitive method. Even trace amounts of bilirubin are sufficiently abnormal to require further investigation. Atypical As with all laboratory tests, definitive diagnostic or therapeutic colors (colors produced which are different than the negative or decisions should not be based on any single test result or method. positive color blocks shown on the Color Chart) may indicate that bilirubin derived bile pigments are present in the urine sample and Glucose: Moderate amounts of ketone bodies (40mg/dL or greater)
are possibly masking the bilirubin reaction. may decrease color development in urine containing small amounts of glucose (75-125 mg/dl). However, such concentration of ketone simultaneously with such glucose concentration is metabolically Ketone: Normally, no ketones are present in urine. Detectable
Ketone: The ketone test area provides semi-quantitative results and
levels of ketone may occur in urine during physiological stress reacts with acetoacetic acid in urine. This test does not react with conditions such as fasting, pregnancy, and frequent strenuous beta-hydroxybutyric acid or acetone. The reagent area detects as exercise.6-8 In starvation diets, or in other abnormal carbohydrate little as 5-10 mg/dl acetoacetic acid in urine. metabolism situation, ketones appear in the urine in excessively large amounts before serum ketones are elevated.9 Specific Gravity: The specific gravity test permits determination of
urine specific gravity between 1.000 and 1.030. In general, the Specific Gravity: Random urine may vary in specific gravity from
specific gravity test correlates within 0.005 with values obtained 1.003-1.040+. Twenty-four hour urine from normal adults with with the reflective index method. normal diets and normal fluid intake will have a specific gravity of 0.016-1.02210 in severe renal damage the specific gravity is fixed at Blood: At the time of reagent manufacture, this test when read as
1.010, the value of the glomerular filtrate. instructed has a sensitivity to free hemoglobin of 0.015 mg/dl or 5- 10 intact red blood cells/µL urine. This test is slightly more Blood: Any green spots or green color developing on the reagent
sensitive to free hemoglobin and myoglobin than to intact area within 40 seconds is significant and the urine should be examined further. Blood is frequently, but not invariably found in the urine of menstruating females. pH: The pH test area permits quantitative differentiation of pH

pH: newborn: 5-7 thereafter: 4.5-8 average: 6.3
values to one unit within the range of 5-9. pH reading is not affected by variation in the urinary buffer concentration. Protein: In 24-hour urine, 1-14 mg/dl of protein may be excreted
by the normal kidney.4 A color matching any color block greater Protein: The test area is more sensitive to albumin than to globulin,
than trace indicates significant proteinuria. For urine with high hemoglobin, Bence-Jones proteins, and mucoprotein; a negative specific gravity, the test area may most closely match the trace color result does not rule out the presence of these other proteins. The test block even though only normal concentrations of protein are area is sensitive to 15 mg/dl albumin. Depending on the inherent present. Clinical judgment is needed to evaluate the significance of variability in clinical urine lesser concentration may be detected under certain conditions. Urobilinogen: In a healthy population, the normal urine
Urobilinogen: This test will detect urobilinogen in concentrations
urobilinogen range obtained with this test is 0.2-1.0 Ehrlich Unit/dl. as low as 0.2 EU/dl in urine. The absence of urobilinogen in the A result of 2.0 EU/dl may be of clinical significance and the same specimen being tested cannot be determined with this test. patient sample should be evaluated further. Nitrite: At the time of reagent manufacture, this test has sensitivity
Nitrite: Normally no detectable amount of nitrite is present in
to sodium nitrite of 0.075 mg/dl. Comparison of the reacted reagent urine.3 The nitrite area will be positive in a proportion of cases of area on a white background may aid in the detection of low levels of significant infection, depending on how long the urine specimens nitrite ion, which may otherwise be missed. This test is specific for were retained in the bladder prior to collection. Retrieval of positive nitrite and will not react with substances normally excreted in the cases with the nitrite test range from as low as 40%, in instances where little bladder incubation occurred, to as high as 80% in instances where a minimum of 4 hours incubation occurred. Leukocytes: This test can detect as low as 10-15 WBC/µL. This
test will not react with erythrocytes or bacteria common in urine. Leukocytes: Normal urine specimens generally yield negative
results with this test. A trace result may be of questionable clinical significance and it is recommended that the test be repeated using a 1. Free, A.H and Free, H.M.: Urinalysis, Critical Discipline of fresh sample from the same patient. Repeated trace and positive Clinical Science. CRC Crit. Rev. Clin. Lab. Sci. 3(4): 481-531; results are of clinical significance. 2. Yoder, J.Adams, E.C., and Free. H.M.: Simultaneous SPECIFIC PERFORMANCE CHARACTERISTICS
Screening for Urinary Occult Blood, Protein, Glucose and pH. The performance characteristics of Urine Strips have been Amer. J. Med Tech. 31:285; (1965). determined both in the laboratory and in clinical tests. Parameters 3. Tietz, N.W.: Clinical Guide to Laboratory Tests; W.B. of importance to the user are sensitivity, specificity, accuracy, and Saunders Company, (1976). precision. Generally, Urine Strips have been developed to be 4. Burtis, C.A. and Ashwood, E.R.: Tietz Textbook of Clinical specific for the constituent to be measured with the exception of Chemistry 2nd Ed. 2205; (1994). interferences listed above. 5. Shchersten, B. and Fritz, H.: Subnormal Levels of Glucose in (See LIMITATIONS OF PROCEDURE) Urine. JAMA 201:129-132; (1967). 6. McGarry, J.D.: Lilly Lecture, 1978: New Perspectives in the For visually read strips, accuracy is a function of the manner in Regulation of Ketogenesis. Diabetes 28: 517-523 May, (1978). which the color blocks on the bottle label are determined and the 7. Williamson, D.H.: Physiological ketoses, or Why Ketone discrimination of the human eye in reading the test. Precision is Bodies? Postgrad. Med. J. (June Suppl.): 371-375: (1971). difficult to assess in a test of this type because of the variability of 8. Paterson, P. et al.: Maternal and Fetal Ketone Concentrations in the human eye. It is for this reason that users are encouraged to Plasma and Urine. Lancet: 862-865; April 22, (1967). develop their own standards of performance. 9. Fraser, J. et al.: Studies with a Simplified Nitroprusside Test for Ketone Bodies in Urine, Serum, Plasma and Milk. Clin. Chem. Glucose: This test is specific for glucose; no substances excreted in
Acta II: 372-378; (1965). urine other than glucose is known to give a positive result. The 10. Henry, J.B. et al.: Clinical Diagnosis and Management by reagent area does not react with lactose, galactose, fructose, or Laboratory Methods, 16th Ed. Philadelphia: Saunders; (1979). reducing metabolites of drugs; e.g. salicylates and nalidixic acid. This test may be used to determine whether the reducing substances found in urine is glucose. Approximately 100 mg/dl glucose in urine is detectable. Bilirubin: The test has a sensitivity of 0.4-0.8 mg/dl bilirubin in
urine. The test is considered specific for bilirubin in urine.

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Consult Instructions for Use Caution,consult accompanying documents In Vitro Diagnostic Medical Device Temperature limitation Contains sufficient for n tests Authorized Representative in the European Catalogue number Orgenics Ltd., part of the Inverness Orgenics France S.A. Medical Innovations Group. 19, rue Lambrechts P.O.B 360, Yavne 70650, Israel 92400 Courbevoie, France Tel.: +972-8-942 9201 Fax.: +972-8-943 8758

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