ATLAS LINK, INC.

Catalog # URS-10
12720 DOGWOOD HILLS LANE FAIRFAX VA, 22033 100 strips per box
TEL: 703-266-5667, FAX: 703-266-5664
Urine Reagent Strips for Glucose, Bilirubin, Ketone, Specific
Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and
Leukocytes.

INTENDED USE: URS 10 for Urinalysis are firm plastic strips to which are Glucose: 16.3% w/w glucose oxidase (Aspergillus niger, 1.3 IU); 0.6% w/w
affixed several separate reagent areas. URS 10 provide tests for the semi- peroxidase (Horseradish, 3300 IU); 7.0% w/w of potassium iodide; 76.1% w/w
quantitative determination of glucose, bilirubin, ketone, specific gravity, blood, buffer and nonreactive ingredients.
pH, protein, urobilinogen, nitrite and leukocytes in urine. Test results may
provide information regarding the status of carbohydrate metabolism, kidney Bilirubin: 0.4% w/w 2,4-dichloroaniline diazonium salt, balanced with buffer
and liver function, acid-base balance, and bacteriurea.1,2 and nonreactive ingredients

SUMMARY AND EXPLANATION: The reagent test areas of urine reagent Specific Gravity: 2.8% w/w bromthymol blue; 1.2% polyacid; 96.0%
strips are ready to use upon removal from the bottle. The entire reagent strip is nonreactive ingredients.
disposable. No additional laboratory equipment is necessary for testing. The
directions must be followed exactly. Accurate timing is essential to provide Ketone: 7.1% w/w sodium nitroprusside buffer balanced with buffer and
optimal results. The reagent strips must be kept in the bottle with the cap tightly nonreactive ingredients.
closed (as specified on the bottle) to maintain reagent reactivity. To obtain
optimal results, it is necessary to use fresh, well-mixed, and uncentrifuged urine. Blood: 22.5% w/w cumene hydroperoxide, balanced with buffer and
nonreactive ingredients
TEST PRINCIPLES:
Glucose: This test is based on a double sequential enzyme reaction. One pH: 0.2% w/w methyl red; 2.8% w/w bromthymol blue; 97% w/w nonreactive
enzyme, glucose oxidase, catalyzes the formation of gluconic acid and hydrogen ingredients.
peroxide from the oxidation of glucose. A second enzyme, peroxidase,
catalyzes the reaction of hydrogen peroxide with a potassium iodide chromogen Protein: 0.3% w/w tetrabromphenol blue; 99.7% w/w buffer and nonreactive
to oxidize the chromogen to colors ranging from green to brown. ingredients.

Bilirubin: This test is based on the coupling of bilirubin with diazotized Urobilinogen: 2.9% w/w p-diethylaminobenzaldehyde, balanced with buffer
dichloroaniline in a strongly acid medium. and nonreactive ingredients

Ketone: This test is based on the reaction between acetoacetic acid with Nitrite: 1.4% w/w p-Arsanilic acid, balanced with buffer and nonreactive
nitroprusside. The colors range from buff-pink, for a "Negative" reading to ingredients.
purple.
Leukocytes: 0.4% derivative of naphthyl ester; 0.2% w/w diazonium salt;
Specific Gravity: This test is based on the release of protons from a polyacid in 99.4% buffer and nonreactive ingredients.
the presence of cations in the test liquid. A colored reaction is produced when
the protons released change the indicator bromthymol blue from blue to blue- WARNINGS AND PRECAUTIONS: Urine reagent strips are for in vitro
green to yellow. diagnostic use.

Blood: This test is based on the peroxidase-like activity of hemoglobin which STORAGE: Store at temperature between 15 - 30°C (59 - 86° F) and out of
catalyzes the reaction of cumene-hydroperoxide and 3,3',5,5' direct sunlight. Do not use after expiration date.
tetramethylbenzidine. The resulting color ranges from orange through green to
dark blue. RECOMMENDED HANDLING PROCEDURES: All unused strips must
remain in the original bottle. Transfer to any other container may cause reagent
pH: This test is based on a double indicator principle that gives a broad range strips to deteriorate and become nonreactive. Do not remove desiccant(s) from
of colors covering the entire urinary pH range. Colors range from orange bottle.
through yellow and green to blue.
SPECIMEN COLLECTION AND PREPARATION: Collect urine in a
Protein: This test is based on the protein error-of-indicators principle. At a clean container according to NCCLS GP16-T guideline and test as soon as
constant pH, the development of any green color is due to the presence of possible. If testing cannot be done within an hour after voiding, refrigerate the
protein. Colors range from yellow for "Negative" through yellow-green and specimen immediately and let it return to room temperature before testing.
green to green-blue for "Positive" reactions. Prolonged exposure of unpreserved urine to room temperature may result in
microbial proliferation with resultant changes in pH. A shift to alkaline pH may
Urobilinogen: This tests is based on a modified Ehrlich reaction in which p- cause false positive results with the protein test area. Urine containing glucose
diethylaminobenzaldehyde reacts with urobilinogen in a strong acid medium to may decrease in pH as organisms metabolize the glucose.
produce a pink color.
Contamination of the urine specimen with skin cleansers containing
Nitrite: This test depends upon the conversion of nitrate to nitrite by the action chlorhexidine may affect protein test results. The user should determine
of gram negative bacteria in the urine. The nitrite reacts with p-Arsanilic acid to whether the use of such skin cleanser is warranted.
form a diazonium compound in acid medium. The diazonium compound in turn
couples with 1,2,3,4-tetrahydrobenzo(h)quinolin to produce a pink color. MATERIALS PROVIDED:
1. 1 bottle containing 100 strips of URS 10.
Leukocytes: This test is based on the action of esterase present in leukocytes,
which catalizes the hydrolysis of an naphthyl ester derivative. The naphthyl 2. A visual color chart for reading results is printed on the bottle.
liberated reacts with a diazonium salt to produce a beige-pink to purple color.

REAGENTS: (Based on dry weight at time of impregnation)

Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, [email protected]
 pH: If proper procedure is not followed and excess urine remains on the strip, a
MATERIALS REQUIRED BUT NOT PROVIDED: phenomenon known as "runover" may occur, in which the acid buffer from the
1. A timer capable of reading accurately in seconds. protein reagent will run onto the pH area, causing a false lowering in the pH
result.
2. It is also recommended that commercial control products be used
for quality control checks. Protein: False positive results may be obtained with highly buffered or alkaline
urine. Contamination of the urine specimen with quaternary ammonium
PROCEDURE: MUST BE FOLLOWED EXACTLY TO ACHIEVE compounds may also produce false positive results.4
RELIABLE TEST RESULTS.
1. Remove one strip from bottle and close the cap immediately. Completely Urobilinogen: The test area will react with interfering substances known to
immerse reagent areas of the strip in FRESH urine and remove react with Ehrlich's reagent, such as porphobilinogen and p-aminosalicylic
immediately to avoid dissolving out of reagents. acid.3 The test is not a reliable method for the detection of porphobilinogen.
Drugs containing azo-dyes (e.g., Azo Gantrisin) may give a masking golden
2. While removing, run the edge of the strip against the rim of the urine color. The absence of urobilinogen cannot be determined with the product.
container to remove excess urine. Hold the strip in a horizontal position
and bring the edge of the strip into contact with an absorbent material Nitrite Test: The pink color is not quantitative in relation to the number of
(paper towel) to prevent possible mixing of chemicals from adjacent bacteria present. Any degree of pink coloration should be interpreted as a
reagent areas and/or soiling of hands with urine. positive nitrite test suggestive of 105 or more organisms/ml. There are
occasional urinary tract infections from organisms which do not contain
3. Compare reagent areas to corresponding color chart on the bottle label at reductase to convert nitrate to nitrite.
the time specified. HOLD STRIP CLOSE TO COLOR BLOCKS AND
MATCH CAREFULLY. Leukocytes: Highly colored urine and the presence of the drugs cephalexin
(Keflex®) and gentamicin have been found to interfere with this test. High
4. Do not use the same urine sample or control more than once. Always test
urinary protein of 500mg/dL or above diminish the intensity of the reaction
with fresh sample.
color. Elevated glucose concentration or high specific gravity may caused
decreased test results.
QUALITY CONTROL: For best results, performance of reagent strips should
be confirmed by testing known negative and positive specimens or control
EXPECTED VALUES:
whenever a new test is performed or whenever a new bottle is first opened.
Negative and positive specimens or controls may also be randomly hidden in Glucose: Small amount of glucose are normally excreted by the kidney. 5
each batch of specimens tested. Each laboratory should establish its own goals Concentrations of as little as 0.1 g/dL glucose, read either at 10 or 30 seconds,
for adequate standards of performance, and should question handling and testing may be significantly abnormal if found consistently. At 10 seconds, results
procedures if these standards are not met. should be interpreted qualitatively; i.e., negative or positive. for quantitative
results, read at 30 seconds only.
RESULTS: Results are obtained by direct comparison of the color blocks
printed on the bottle label. The color blocks values represent nominal values; Bilirubin: Normally no bilirubin is detectable in urine by even the most
actual values will vary around the nominal values. sensitive methods. Even trace amounts of bilirubin are sufficiently abnormal to
require further investigation. Atypical colors (colors produced which are
LIMITATIONS OF PROCEDURE: different than the negative or positive color blocks shown on the Color Chart)
Glucose: Large amounts of ketone bodies (50 mg/dL or greater) may decrease may indicate that bilirubin derived bile pigments are present in the urine sample
color development. However, it is unlikely that the presence of ketones and are possibly masking the bilirubin reaction.
simultaneously with glucose in the urine is sufficient to produce false negative
results. At glucose levels of 1 g/dL or greater, the color may appear somewhat Ketone: Normally no ketones are present in urine. Detectable levels of ketone
mottled. The darkest color should be used in interpreting results with the color may occur in urine during physiological stress conditions such as fasting,
chart. The reactivity of the glucose test decreases as the SG of the urine pregnancy, and frequent strenuous exercise.6-8 In starvation diets, or in other
increases. Reactivity may also vary with temperature.3 abnormal carbohydrate metabolism situation, ketones appear in the urine in
excessively large amounts before serum ketones are elevated.10
Bilirubin: Reactions may occur with urine specimens containing large doses of
chlorpromazine or rafampen which might be mistaken for positive bilirubin. 3 Specific Gravity: Random urines may vary in specific gravity from 1.003-
1.040+. Twenty-four hour urines from normal adults with normal diets and
Indican (indoxyl sulfate) and metabolites of Lodine â may cause false positive or
atypical color; ascorbic acid (25 mg/dL or greater) may cause false negatives. normal fluid intake will have a specific gravity of 1.016-1.022.9

Ketone: Color reaction that could be interpreted as "positive" may be obtained In severe renal damage the specific gravity is fixed at 1.010, the value of the
with urine specimens containing MESNA or large amounts of phenylketones or glomerular filtrate.
L-dopa metabolites.3
Blood: Any green spots or green color developing on the reagent area within 40
Specific Gravity: The chemical nature of the specific gravity test may cause
seconds is significant and the urine should be examined further. Blood is
slightly different results from those obtained with other specific gravity methods
frequently, but not invariably, found in the urine of menstruating females.
when elevated amounts of certain urine constituents are present.

Highly buffered alkaline urines may cause low readings relative to other pH:3 newborn: 5 - 7 thereafter: 4.5 - 8 average: 6
methods. Elevated specific gravity readings may be obtained in the presence of
moderate quantities (100-750 mg/dL) of protein. Acidic urines (pH 5 or below) Protein: In 24 hours urine, 1-14 mg of protein in 1 dL of urine may be excreted
may cause elevated results. by the normal kidney.4 A color matching any block greater than Trace indicated
significant proteinuria. For urine of high specific gravity, the test area may most
Blood: The sensitivity of the blood test is reduced in urine with high specific closely match the trace color block even though only normal concentrations of
gravity and/or high ascorbic acid content. Microbial peroxidase, associated with protein are present. Clinical judgement is needed to evaluate the significance of
urinary tract infection, may cause a false positive reaction. trace results.

Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA

Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, [email protected]
Urobilinogen: In a healthy population, the normal urine urobilinogen range Urobilinogen Test: This test area gives quantitative results and will detect
obtained with this test is 0.2 to 1.0 Ehrlich unit per dL. A result of 2.0 EU/dL urobilinogen in concentrations as low as an Ehrlich unit/dL in urine. The
may be of clinical significance and the same patient sample should be evaluated absence of urobilinogen in the specimen being tested cannot be determined.
further.
Nitrite test: At the time of reagent manufacture, the test has a sensitivity to
Nitrite: Normally no detectable amount of nitrite is present in urine. 3 The sodium nitrite of 0.075 mg/dL in urine having low specific gravity and less than
nitrite area will be positive in a proportion of cases of significant infection, 5 mg/dL ascorbic acid. Comparison of the reacted reagent area on a white
depending on how long the urine specimens were retained in the bladder prior to background may aid in the detection of these low levels which may otherwise be
collection. Retrieval of positive cases with the nitrite test range from as low as missed. The test is specific for nitrite and will not react with any other
40% in instances where little bladder incubation occurred, to as high as substance normally excreted in urine.
approximately 80% in instances where a minimum of 4 hours incubation
occurred. Leukocytes: This test can detect as low as 10-15 WBC/L. 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 BIBLIOGRAPHY:
recommended that the test be repeated using a fresh sample from the same 1. Free, A.H. and Free, H.M.: Urinalysis, Critical Discipline of Clinical
patient. Repeated trace and positive results are of clinical significance. Science. CRC Crit. Rev. Clin. Lab. Sci. 3(4): 481-531; (1972).
2. Yoder, J..Adams, E.C., and Free, H.M.: Simultaneous screening for
SPECIFIC PERFORMANCE CHARACTERISTICS: urinary occult blood, protein, glucose and pH. Amer. J. Med Tech. 31:
The performance characteristics of URS 10 urine reagent strips have been 285; (1965).
determined both in the laboratory and in clinical tests. Parameters of importance 3. Tietz, N.W.: Clinical Guide to Laboratory Tests; W.B. Saunders Company,
to the user are sensitivity, specificity, accuracy and precision. Generally, this (1976).
test has been developed to be specific for the constituent to be measured with the 4. Burtis C.A. and Ashwood E.R.: Tietz Textbook of Clinical Chemistry 2nd.
exception of interferences listed previously (see LIMITATIONS OF Ed. 2205; 1994
PROCEDURE). 5. Schersten, B. and Fritz, H.: Subnormal Levels of Glucose in urine. JAMA
201:129-132; (1967).
For visually read strips, accuracy is a function of the manner in which the color 6. McGurry, J.D.: Lilly Lecture, 1978: New Perspectives in the Regulation of
blocks on the bottle label are determined and the discrimination of the human Ketogenesis. Diabetes 28: 517-523 May, (1978).
eye in reading the test. Precision is difficult to assess in a test of this type 7. Williamson, D.H. Physiological Ketoses, or Why Ketone Bodies?
because of the variability of the human eye. It is for this reason that users are Postgrad. Med. J. (June Suppl.): 371-375; (1971).
encouraged to develop their own standards of performance. 8. Paterson, P. et al.: Maternal and Fetal Ketone Concentrations in Plasma
and Urine. Lancet: 862-865; April 22, (1967).
Sensitivity: 9. Henry, J.B. et al.: Clinical Diagnosis and Management by Laboratory
Methods, 16th ed. Philadelphia: Saunders; 1979: pp.579-608.
Glucose Test: This reagent test area may be read at 10 seconds for qualitative 10. Fraser, J.et al.: Studies with a Simplified Nitroprusside Test for Ketone
results or 30 seconds for quantitative results. The test is specific for glucose; no Bodies in Urine, Serum, Plasma and Milk. Clin. Chem. Acta II: 372-378;
substance excreted in urine other than glucose is known to give a positive result. (1965).
The reagent area does not react with lactose, galactose, fructose, nor reducing * Trademarks
metabolites of drugs; e.g., salicylates and nalidixic acid. This test may be used Serenium® is a registered trademark of E.R. Squibb & Sons.
to determine whether the reducing substance found in urine is glucose. Pyridum® is a registered trademark of Warner-Chilcott Laboratories.
Approximately 0.1 g of glucose per dL or urine is detectable. Azo Gantrisin® and Azo Gantanol® are registered trade marks of
Roche Laboratories, Division of Hoffman-LaRoche, Inc.
Bilirubin Test: The test has a sensitivity of 0.2 - 0.4 mg bilirubin/dL. The test
Lodine® is a registered trademark of Wyeth-Ayerst Laboratory.
is considered specific for bilirubin in urine.1
Macrodantin® and Furadantin® are registered trade marks of Norwich-
Ketone Test: The ketone test area provides semi-quantitative results (small, Eaton Pharmaceuticals.
moderate, and large) and reacts with acetoacetic acid in urine. It does not react
with beta-hydroxybutyric acid or acetone. The reagent area detects as little as 5
Keflex® is a registered trademark of Dista Products Company.
to 10 mg acetoacetic acid per dL of urine.
Revised: 11/96
Specific Gravity: The specific gravity test permits determination of urine
specific gravity between 1.000 and 1.030. In general, it correlates within 0.005
with values obtained with the refractive index method.

Blood Test: At the time of reagent manufacture, the test when read as
instructed has a sensitivity to free hemoglobin of 0.015 mg/dL or 5 to 10 intact
red blood cells/uL in urines with a specific gravity of 1.005 and ascorbic acid
content of <5mg/dL. The test is slightly more sensitive to free hemoglobin and
myoglobin than to intact erythrocytes.

pH Test: The pH test area permits quantitative differentiation of pH values to

one unit within the range of 5 - 9. pH readings are not affected by variation in
the urinary buffer concentration.

Protein Test: Quantitative results are obtained from this test area. 5 to 20 mg
of albumin per dL urine may be detected as a "Trace" result. The test area is
more sensitive to albumin than to globulin, hemoglobin, and mucoprotein; a
negative result, therefore, does not rule out the presence of these other proteins.

Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA

Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, [email protected]
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