Urs11.doc

TECO DIAGNOSTICS
Note: This Package Insert for use with the products listed below.
URS -11 • URS -10 • URS -9 • URS -8 • URS -7 • URS -7L • URS -7S • URS -6 • URS -6L • URS -5K • URS -5N • URS -5U URINE REAGENT STRIPS FOR URINALYSIS
For the Semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes, and Ascorbic Acid in Urine

SUMMARY
diazonium compound in turn couples with 1,2,3,4-tetrahydrobenzo(h) testing cannot be performed within one hour after voiding, refrigerate the Teco Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to specimen immediately. Allow refrigerated specimen to return to room which several different reagent areas are affixed. Depending on the product being used, Teco Urine Reagent Strips provide tests for Glucose, Leukocytes: This test is based on the action of esterase present in
Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, leukocytes, which catalyzes the hydrolysis of an indoxyl ester derivative. TEST PROCEDURE
Urobilinogen, Nitrite, Leukocytes and Ascorbic Acid in Urine. Test results The indoxyl ester liberated reacts with a diazonium salt to produce a Remove from the bottle only enough strips for immediate use and may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and Completely immerse reagent areas of the strip in fresh, well-mixed Ascorbic Acid: The composition comprises of a complex chelating
Please refer to the outside box and bottle label for the urine. Remove the strip immediately to avoid dissolving out the agent with a polyvalent metal ion in its higher state and an indicator dye specific test parameters of the product you are using. that can reacts with the metal ion in its lower state to produce a red color. While removing, touch the side of the strip against the rim of the Teco Urine Reagent Strips are packaged along with a drying agent in a urine container to remove excess urine. Blot the lengthwise edge plastic bottle with a twist-off cap. Each strip is stable and ready to use REAGENTS (Based on dried weight at time of impregnation)
of the strip on an absorbent paper towel to further remove excess upon removal from the bottle. The entire reagent strip is disposable. Glucose: 16.3%w/w glucose oxidase (Aspergillus niger, 1.3IU);
urine and avoid running over (contamination from adjacent reagent Results are obtained by direct comparison of the test strip with the color 0.6%w/w peroxidase (horseradish, 3300 IU); 7.0% w/w potassium iodide; blocks printed on the bottle label. No calculations or laboratory 76.1% w/w buffer and nonreactive ingredients. Compare each reagent area to its corresponding color blocks on Bilirubin: 0.4% w/w 2,4-dichloroaniline diazonium salt, balanced with
the color chart and read at the times specified. Proper read time is TEST PRINCIPLE
Glucose: This test is based on a double sequential enzyme reaction.
Ketone: 7.7% w/w sodium nitroprusside balanced with buffer and non-
One enzyme, glucose oxidase, catalyzes the formation of gluconic acid and hydrogen peroxide from the oxidation of glucose. A second enzyme, peroxidase, catalyzes the reaction of hydrogen peroxide with potassium Specific Gravity: 2.8% w/w bromothymol blue, 69.0%; poly (methyl vinyl
iodide chromogen to oxidize the chromogen to colors ranging from blue- ether/maleic anhydride); 28.2% sodium hydroxide green to greenish-brown through brown and dark brown.
Blood: 6.6% w/w cumene hydroperoxide; 4.0% w/w 3, 3’, 5, 5’-

Bilirubin: This test is based on the coupling of bilirubin with a diazotized
tetramethylbenzidine; 89.4% w/w buffer and nonreactive ingredients. dichloroaniline in a strongly acid medium. The colors range f rom light tan pH: 0.2% w/w methyl red; 2.8% w/w bromothymol blue; 97% w/w
nonreactive ingredients.
Obtain results by direct color chart comparison. Ketone: This test is based on the reaction of acetoacetic acid with
Note: All reagent areas except Leukocytes may be read between 1-2 Protein: 0.3% w/w tetrabromophenol blue; 99.7% w/w buffer and
sodium nitroprusside in a strongly basic medium. The colors range from minutes for screening positive urine from negative urine. Changes in beige or buff-pink color for a “Negative” reading to pink and pink -purple color after 2 minutes are of no diagnostic value. Urobilinogen: 2.9% w/w p-diethylaminobenzaldehyde balanced with
QUALITY CONTROL
Specific Gravity: This test is based on the apparent pKa change of
For best results, performance of reagent strips should be confirmed by certain pretreated polyelectrolytes in relation to the ionic concentration. Nitrite: 1.4% w/w p-arsanilic acid, balanced with buffer and nonreactive
testing known negative and positive specimens or controls whenever a In the presence of an indicator, the colors range from dark blue or blue- new test is performed or whenever a new bottle is first opened. Each green in urine of low ionic concentration to green and yellow-green in laboratory should establish its own goals for adequate standards of Leukocytes: 0.4% w/w indoxyl ester derivative; 0.2%w/w diazonium salt;
performance, and should question handling and testing procedures if 99.4% w/w buffer and nonreactive ingredients. Blood: This test is based on the pseudoperoxidase action of hemoglobin
and erythrocytes which catalyzes the reaction of 3,3’, 5, 5’-tetramethyl- Ascorbic Acid: 5.8% w/w ferric chloride; 4.9% w/w DTPA; 1.2%
benzidine and buffered organic peroxide. The resulting colors range from dipyridyl; 89.1% w/w buffer and nonreactive ingredients. Results are obtained by direct comparison of the color blocks printed on orange to yellow-green and dark green. Very high blood concentration the bottle label. The color blocks represent nominal values; ac tual values may cause the color development to continue to dark blue. WARNINGS AND PRECAUTIONS
Urine Reagent Strips are for in vitro diagnostic use. Do not touch test pH: This test is based on the well known double pH indicator method,
LIMITATIONS OF PROCEDURE
where bromothymol blue and methyl red give distinguishable colors over Comparison to the color chart is dependent on the interpretation of the the pH range of 5-9. The colors range from red-orange to yellow and individual. It is therefore, recommended that all laboratory personnel Store at room temperature between 15°-30°C (59°-86°F) and out of direct interpreting the results of these strips be tested for color blindness. sunlight. Do not use after expiration date. Protein: This test is based on the protein error-of -indicator principle. At
As with all laboratory tests, definitive diagnostic or therapeutic decisions a constant pH, the development of any green color is due to the presence RECOMMENDED HANDLING PROCEDURES
should not be based on any single test result or method. of protein. Colors range from yellow for a “Negative” reaction to yellow- All unused strips must remain in the original bottle. Transfer to any green and green to blue-green for a “Positive” reaction. container may cause reagent strips to deteriorate and become Glucose: Moderate amounts of ketone bodies (40mg/dL or greater) may
nonreactive. Do not remove desiccant from bottle. Do not open decrease color development in urine containing small amounts of glucose Urobilinogen: This test is based on a modified Ehrlich reaction in which
container until ready to use. Opened bottles should be used within 3 (75-125 mg/dl). However, such concentration of ketone simultaneously p-diethylaminobenzaldehyde reacts with urobilinogen in a strongly acid with such glucose concentration is metabolically improbable in screening. medium. Colors range from light pink to bright magenta. The reactivity of the glucose test decreases as the SG of the urine SPECIMEN COLLEC TION AND PREPARATION
increases. Reactivity may also vary with temperature. Nitrite: This test depends on the conversion of nitrate to nitrite by the
Collect urine in a clean container and test as soon as possible. Do not action of Gram -negative bacteria in the urine. The nitrite reacts with p- centrifuge. The use of urine preservatives is not recommended. If arsanilic acid to from a diazonium compound in an acid medium. The Bilirubin: Reactions may occur with urine containing large doses of
normal fluid intake will have a specific gravity of 0.016-1.022 In severe Ketone: The ketone test area provides semi-quantitative results and
chlorpromazine or rafampen that might be mistaken for positive bilirubin. renal damage the specific gravity is fixed at 1.010, the value of the reacts with acetoacetic acid in urine. This test does not react with beta- Indican (indoxyl sulfate) and metabolites of Lodine may cause false hydroxybutyric acid or acetone. The reagent area detects as little as positive or atypical color; ascorbic acid (25mg/dL or greater) may cause Blood: Any green spots or green color developing on the reagent area
within 40 seconds is significant and the urine should be examined further. Specific Gravity: The specific gravity test permits determination of urine

Ketone: Color reaction that could be interpreted as “positive” may be
Blood is frequently, but not invariably found in the urine of menstrating specific gravity between 1.000 and 1.030. In general, the specific gravity obtained with urine specimens containing MESNA or large amounts of test correlates within 0.005 with values obtained with the reflective index pH: newborn: 5-7 thereafter: 4.5-8 average: 6.
Specific Gravity: The chemical nature of the specific gravity test may
Blood: At the time of reagent manufacture, this test when read as
cause slightly different results from those obtained with the specific Protein: In 24-hour urine, 1-14 mg/dl of protein may be excreted by the
instructed has a sensitivity to free hemoglobin of 0.03 mg/dl or 10 intact gravity methods when elevated amounts of certain urine constituents are normal kidney. A color matching any color block greater than trace red blood cells/µL urine. This test is slightly more sensitive to free present. Highly buffered alkaline urine may cause low readings relative indicates significant proteinuria. For urine with high specific gravity, the hemoglobin and myoglobin than to intact erythrocytes. to other methods. Elevated specific gravity readings may be obtained in test area may most closely match the trace color block even though only the presence of moderate quantities (100-750 mg/dl) of protein. normal concentrations of protein are present. Clinical judgement is pH: The pH test area permits quantitative differentiation of pH values to
needed to evaluate the significanc e of trace results. one unit within the range of 5-10. pH reading is not affected by variation Blood: The sensitivity of the blood test is reduced in urine with high
specific gravity and/or high ascorbic acid content. Microbial peroxidase, Urobilinogen: In a healthy population, the normal urine urobilinogen
associated with urinary tract infection may cause false positive reactions. range obtained with this test is 0.2-1.0 Ehrlich Unit/dl. A result of 2.0 Protein: The test area is more sensitive to albumin than to globulin,
EU/dl may be of clinical significance and the same patient sample should hemoglobin, Bence-Jones proteins, and mucoprotein; a negative result pH: If proper procedure is not followed and excess urine remains on the
does not rule out the presence of these other proteins. The test area is strip, a phenomenon known as “running over” may occur, in which the sensitive to 30 mg/dl albumin. Depending on the inherent variability in acid buffer from the protein reagent area run onto the pH area, causing a Nitrite: Normally no detectable amount of nitrite is present in urine.
clinical urine lesser concentration may be detected under certain The nitrite area will be positive in a proportion of cases of significant infection, depending on how long the urine specimens were retained in Protein: False positive results may be obtained with highly alkaline
the bladder prior to collection. Retrieval of positive cases with the nitrite Urobilinogen: This test will detect urobilinogen in concentrations as low
urine. Contamination of the urine specimen with quarternary ammonium test range from as low as 40%, in instances where little bladder as 0.2 EU/dl in urine. The absence of urobilinogen in the specimen being compounds may also produce false positive results. incubation occurred, to as high as 80% in instances where a minimum of tested cannot be determined with this test. Urobilinogen: The test area will react with interfering substances known
Nitrite: At the time of reagent manufacture, this test has sensitivity to
to react with Ehrlich’s reagent, such as porphobilinogen and p- Leukocytes: Normal urine specimens generally yield negative results
sodium nitrite of 0.05 mg/dl. Comparison of the reacted reagent area on aminosalicyclic acid. This test is not a reliable method for the detection with this test. A trace result may be of questionable clinical significance a white background may aid in the detection of low levels of nitrite ion, of porphobilinogen. Drugs containing azo-dyes (e.g. Azo Gantrisin) may and it is recommended that the test be repeated using a fresh sample which may otherwise be missed. This test is specific for nitrite and will give a masking golden color. The absence of urobilinogen cannot be from the same patient. Repeated trace and positive results are of clinical not react with substances normally excreted in the urine. Leukocytes: This test can detect as low as 10-15 WBC/µL. This test
Nitrite: The pink color is not quantitative in relation to the number of
Ascorbic Acid: The daily urinary output of ascorbic acid varies with the
will not react with erythrocy tes or bacteria common in urine. bacteria present. Any degree of pink coloration should be interpreted as intake: it approximately half of the intake. The average urinary output a positive nitrite test suggestive of 10 or more organisms/ml. There are ranges from 20-30 mg/day. If detect ascorbic acid in urine, stop taking Ascorbic Acid: This test can detect ascorbic acid in concentrations as
occasional urinary tract infections from organisms, which do not contain reductase to convert nitrate to nitrite. False negative and weak reaction of glucose, blood and bilirubin may be BIBLIOGRAPHY
Leukocytes: Highly colored urine and the presence of the drugs
Glucose & Bilirubin: more than 50 mg/dl ascorbic acid in the sample. Free, A.H and Free, H.M.: Urinalysis, Critical Discipline of Clinical Science. cephalexin (Keflex ) and gentamicin have been found to interfere with CRC Crit. Rev. Clin. Lab. Sci. 3(4): 481-531; (1972). Blood: more than 10 mg/dl ascorbic acid in the sample. this test. High urinary protein of 500 mg/dl or above diminishes the Yoder, J.Adams, E.C., and Free. H.M.: Simultaneous Screening for Urinary Occult Blood, Protein, Glucose and pH. Amer. J. Med Tech. 31:285; (1965). intensity of the reaction color. Elevated glucose concentration or high SPECIFIC PERFORMANCE CHARACTERISTICS
Tietz, N.W.: Clinical Guide to Laboratory Tests; W.B. Saunders Company, specific gravity may cause decreased results. The performance characteristics of Teco Urine Reagent Strips (URS) have been determined both in the laboratory and in clinical tests. Burtis, C.A. and Ashwood, E.R.: Tietz Textbook of Clinical Chemistry 2nd Ed. EXPECTED VALUES
Parameters of importance to the user are sensitivity, specificity, accuracy, Glucose: Small amounts of glucose are normally excreted by the
and precision. Generally, Urine Reagent Strips (URS) have been Shchersten, B. and Fritz, H.: Subnormal Levels of Glucose in Urine. JAMA kidney. Concentrations as little as 0.1 g/dl glucose, read either at 10 or developed to be specific for the constituent to be measured with the 30 seconds, may be significantly abnormal if found consistently. At 10 exception of interferences listed above. (See LIMITATIONS OF McGarry, J.D.: Lilly Lecture, 1978: New Perspectives in the Regulation of seconds, results should be interpreted qualitatively; for semi-quantitative Ketogenesis. Diabetes 28: 517-523 May, (1978). Williamson, D.H.: Physiological ketoses, or Why Ketone Bodies? Postgrad. For visually read strips, accuracy is a function of the manner in which the Paterson, P. et al.: Maternal and Fetal Ketone Concentrations in Plasma and Bilirubin: Normally, no bilirubin is detectable in urine by even the most
color bloc ks on the bottle label are determined and the discrimination of Urine. Lancet: 862-865; April 22, (1967). sensitive method. Even trace amounts of bilirubin are sufficiently the human eye in reading the test. Precision is difficult to assess in a test Fraser, J. et al.: Studies with a Simplified Nitroprusside Test for Ketone Bodies abnormal to require further investigation. Atypical colors (colors of this type because of the variability of the human eye. It is for this in Urine, Serum, Plasma and Milk. Clin. Chem. Acta II: 372-378; (1965) produced which are different than the negative or positive color blocks reason that users are encouraged to dev elop their own standards of Henry, J.B. et al.: Clinical Diagnosis and Management by Laboratroy Methods, shown on the Color Chart) may indicate that bilirubin derived bile 16th Ed. Philadelphia: Saunders; (1979). pigments are present in the urine sample and are possibly masking the Glucose: This test is specific for glucose; no substances excreted in
Lodineis a registered trademark of Wyeth-Ayerst Laboratories. urine other than glucose is known to give a positive result. The reagent Ketone: Normally, no ketones are present in urine. Detectable levels of
Azo Gantrisin and Azo Gantanol are registered trademarks of Roche Laboratories. area does not react with lactose, galactose, fructose, or reducing Keflex is a registered trademark of Dista Products Company. ketone may occur in urine during physiological stress conditions such as metabolites of drugs; e.g. salicyclates and nalidixic acid. This test may fasting, pregnancy, and frequent strenuous exercise.
be used to determine whether the reducing substances found in urine is diets, or in other abnormal carbohydrate metabolism situation, ketones glucose. Approximately 50 mg/dl glucose in urine is detectable. appear in the urine in excessively large amounts before serum ketones Bilirubin: The test has a sensitivity of 0.5 mg/dl bilirubin in urine. The
test is considered specific for bilirubin in urine. Specific Gravity: Random urine may vary in specific gravity from 1.003-
1.040+. Twenty -four hour urine from normal adults with normal diets and

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