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
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,
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.
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
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
(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.
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
0.4% w/w 2,4-dichloroaniline diazonium salt, balanced with
the color chart and read at the times specified. Proper read time is
This test is based on a double sequential enzyme reaction.
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
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.
6.6% w/w cumene hydroperoxide; 4.0% w/w 3, 3’, 5, 5’-
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
0.2% w/w methyl red; 2.8% w/w bromothymol blue; 97% w/w
Obtain results by direct color chart comparison.
This test is based on the reaction of acetoacetic acid with
Note: All reagent areas except Leukocytes may be read between 1-2
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.
2.9% w/w p-
diethylaminobenzaldehyde balanced with
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.
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
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.
This test is based on the pseudoperoxidase action of hemoglobin
and erythrocytes which catalyzes the reaction of 3,3’, 5, 5’-tetramethyl-
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
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.
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
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
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
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.
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
Reactions may occur with urine containing large doses of
normal fluid intake will have a specific gravity of 0.016-1.022 In severe
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
Any green spots or green color developing on the reagent area
within 40 seconds is significant and the urine should be examined further.
The specific gravity test permits determination of urine
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
newborn: 5-7 thereafter: 4.5-8 average: 6.
The chemical nature of the specific gravity test may
At the time of reagent manufacture, this test when read as
cause slightly different results from those obtained with the specific
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
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
The sensitivity of the blood test is reduced in urine with high
specific gravity and/or high ascorbic acid content. Microbial peroxidase,
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
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
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
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
False positive results may be obtained with highly alkaline
the bladder prior to collection. Retrieval of positive cases with the nitrite
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.
The test area will react with interfering substances known
At the time of reagent manufacture, this test has sensitivity to
to react with Ehrlich’s reagent, such as porphobilinogen and p
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.
This test can detect as low as 10-15 WBC/µL. This test
The pink color is not quantitative in relation to the number of
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
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
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.
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.
Parameters of importance to the user are sensitivity, specificity, accuracy,
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
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
This test is specific for glucose; no substances excreted in
Lodineis a registered trademark of Wyeth-Ayerst Laboratories.
urine other than glucose is known to give a positive result. The reagent
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
The test has a sensitivity of 0.5 mg/dl bilirubin in urine. The
test is considered specific for bilirubin in urine.
Random urine may vary in specific gravity from 1.003-
1.040+. Twenty -four hour urine from normal adults with normal diets and
AFTERCARE INSTRUCTIONS You have just had a safe and simple pregnancy termination. Even though we expect no complications, it is very important for you to take care of yourself. After your follow-up appointment, you may return to your normal activities. Until then, please follow the suggestions and restrictions that follow. Please keep these instructions so that you can refer to them if
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