Product Manual
URINE REAGENT STRIPS FOR URINALYSIS
This Package Insert to be used with the following products: P080010, P080014 & P080012
For the semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone, Specic Gravity, Blood, pH, Protein,
U
robilinogen, Nitrite, and Leukocytes.
S
UMMARY
U
rine Reagent Strips for Urinalysis are rm plastic strips to which several
d
ifferent reagent areas are afxed. Depending on the product being used,
Pro Advantage by NDC Urine Reagent Strips provide tests for Glucose,
Bilirubin, Ketone (Acetoacetic acid), Specic Gravity, Blood, pH, Protein,
U
robilinogen, Nitrite, and Leukocytes. Test results may provide information
r
egarding the status of carbohydrate metabolism, kidney and liver function,
a
cid-base balance, and bacteriuria.
1,2
P
lease refer to the outside box and
bottle label for the specic test parameters of the product you are using.
U
rine Reagent Strips are packaged along with a drying agent in a plastic
bottle with a twist-off cap. Each strip is stable and ready to use upon
r
emoval from the bottle. The entire reagent strip is disposable. Results are
o
btained by direct comparison of the test strip with the color blocks printed
o
n the bottle label. No calculations or laboratory instruments are required.
T
EST PRINCIPLE
G
lucose: This test is based on a double sequential enzyme reaction. One
e
nzyme, 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
i
odide chromogen to oxidize the chromogen to colors ranging from
b
lue-green to greenish-brown through brown and dark brown.
Bilirubin: This test is based on the coupling of bilirubin with a diazotized
d
ichloroaniline in a strongly acid medium. The colors range from light tan
t
o reddish-brown.
Ketone: This test is based on the reaction of acetoacetic acid with sodium
n
itroprusside in a strongly basic medium. The colors range from beige or
buff-pink color for a “Negative” reading to pink and pink-purple for a
“Positive” reading.
Specic Gravity: This test is based on the apparent pKa change of certain
pretreated polyelectrolytes in relation to the ionic concentration. In the
p
resence of an indicator, the colors range from dark blue or
blue-green in urine of low ionic concentration to green and yellow-green
i
n urine of higher ionic concentration.
Blood: This test is based on the pseudoperoxidase action of hemoglobin and
erythrocytes which catalyzes the reaction of 3,3’,5, 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 principle. At a
constant pH, the development of any green color is due to the presence of
protein. Colors range from yellow for a “Negative” reaction to
yellow-green and green to blue-green for a “Positive” reaction.
Urobilinogen: This test is based on a modied Ehrlich reaction in which
p-diethylaminobenzaldehyde reacts with urobilinogen in a strongly acid
medium. Colors range from light pink to bright magenta.
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 medium. The
diazonium compound in turn couples with 1,2,3,4-tetrahydrobenzo(h)
quinolin to produce a pink color.
Leukocytes: This test is based on the action of esterase present in
leukocytes, which catalyzes the hydrolysis of an indoxyl ester derivative.
The indoxyl ester liberated reacts with a diazonium salt to produce a
beige-pink to purple color.
Ascorbic Acid: This test is based on the action of a complex chelating
agent with a polyvalent metal ion in its higher state and an indicator dye
that can react with the metal ion in its lower state to produce a color
change from blue-green to yellow.
REAGENTS (Based on dried weight at time of impregnation)
Glucose: 16.3%w/w glucose oxidase (Aspergillus niger, 1.3IU); 0.6%w/w
peroxidase (horseradish, 3300 IU); 7.0% w/w potassium iodide; 76.1% w/w
buffer and non-reactive ingredients.
Bilirubin: 0.4% w/w 2,4-dichloroaniline diazonium salt, balanced with
buffer and non-reactive ingredients.
Ketone: 7.7% w/w sodium nitroprusside balanced with buffer and
non-reactive ingredients.
Specic Gravity: 2.8% w/w bromothymol blue, 69.0%; poly (methyl vinyl
ether/maleic anhydride); 28.2% sodium hydroxide
B
lood: 6.6% w/w cumene hydroperoxide; 4.0% w/w 3, 3’, 5, 5’-
t
etramethylbenzidine; 89.4% w/w buffer and nonreactive ingredients.
pH: 0.2% w/w methyl red; 2.8% w/w bromothymol blue; 97% w/w
nonreactive ingredients.
P
rotein: 0.3% w/w tetrabromophenol blue; 99.7% w/w buffer and
n
onreactive ingredients.
U
robilinogen: 2.9% w/w p-diethylaminobenzaldehyde balanced with buffer
a
nd nonreactive ingredients.
N
itrite: 1.4% w/w p-arsanilic acid, balanced with buffer and nonreactive
i
ngredients.
Leukocytes: 0.4% w/w indoxyl ester derivative; 0.2%w/w diazonium salt;
9
9.4% w/w buffer and nonreactive ingredients.
W
ARNINGS AND PRECAUTIONS
Urine Reagent Strips are for in vitro diagnostic use. Do not touch test areas
of Urine Reagent Strips.
S
TORAGE
Store at room temperature between 15°-30°C (59°-86°F) and out of direct
sunlight. Do not use after expiration date.
R
ECOMMENDED HANDLING PROCEDURES
All unused strips must remain in the original bottle. Transfer to any
container may cause reagent strips to deteriorate and become
n
onreactive. Do not remove desiccant from bottle. Do not open container
until ready to use. Opened bottles should be used within 3 months after
rst opening.
SPECIMEN COLLECTION AND PREPARATION
Collect urine in a clean container and test as soon as possible. Do not
c
entrifuge. The use of urine preservatives is not recommended. If testing
cannot be performed within one hour after voiding, refrigerate the
s
pecimen immediately. Allow refrigerated specimen to return to room
t
emperature before testing.
TEST PROCEDURE
1. Remove from the bottle only enough strips for immediate use and
replace cap tightly.
2. Completely immerse reagent areas of the strip in fresh, well-mixed
urine. Remove the strip immediately to avoid dissolving out the
reagent areas.
3. While removing, touch the side of the strip against the rim of the urine
container to remove excess urine. Blot the lengthwise edge of the strip
on an absorbent paper towel to further remove excess urine and avoid
running over (contamination from adjacent reagent pads.)
4. Compare each reagent area to its corresponding color blocks on the
color chart and read at the times specied. Proper read time is critical
for optimal results.
5. Obtain results by direct color chart comparison.
Note: All reagent areas except Leukocytes may be read between 1-2
minutes for screening positive urine from negative urine. Changes in color
after 2 minutes are of no diagnostic value.
QUALITY CONTROL
For best results, performance of reagent strips should be conrmed by
testing known negative and positive specimens or controls whenever a
new bottle is rst opened. Each laboratory should establish its own goals
for adequate standards of performance, and should question handling and
testing procedures if these standards are not met.
RESULTS
Results are obtained by direct comparison of the color blocks printed on
the bottle label. The color blocks represent nominal values; actual values
will vary around the nominal values.
LIMITATIONS OF PROCEDURE
Comparison to the color chart is dependent on the interpretation of the
individual. It is therefore, recommended that all laboratory personnel
interpreting the results of these strips be tested for color blindness.
As with all laboratory tests, denitive diagnostic or therapeutic decisions
should not be based on any single test result or method.