abnormal carbohydrate metabolism situations, ketones p-arsanilic acid to form a diazonium compound. The 2.

5% w/w Determines
appear in the urine in excessively high concentration diazonium compound in turn couples with 1 N-(1- bromthymol blue urine specific
before serum ketones are elevated. naphthyl)- ethylenediamine to produce a pink color. indicator; 17.5% gravity between
Bilirubin: This test is based on azo-coupling reaction of Nitrite is not detectable in normal urine. The nitrite area Specific w/w buffer and 1.000 and
Urine Reagent Strips bilirubin with diazotized dichloroaniline in a strongly will be positive in some cases of infection, depending on 45 non-reactive 1.030. Results
(10 Parameters) Gravity
acidic medium. Varying bilirubin levels will produce a how long the urine specimens were retained in the seconds ingredients; 55% correlate with
(SG)
For rapid detection of multiple analytes in human pinkish-tan color proportional to its concentration in bladder prior to collection. Retrieval of positive cases poly (methyl vinyl values obtained
urine. In normal urine, no bilirubin is detectable by even with the nitrite test ranges from as low as 40% in cases ether/maleic by refractive
urine.
the most sensitive methods. Even trace amounts of where little bladder incubation occurred, to as high as anhydride); 25% index method
For in vitro diagnostic and professional use bilirubin require further investigation. Atypical results approximately 80% in cases where bladder incubation sodium hydroxide within ±0.005.
only. (colors different from the negative or positive color took place for at least 4 hours. 0.3% w/w
blocks shown on the color chart) may indicate that PH: This test is based on a double indicator system which Detects albumin
tetrabromophenol
Store at 15-30℃ bilirubin-derived bile pigments are present in the urine gives a broad range of colors covering the entire urinary Protein 60 blue; 99.7% w/w
as low as 7.5-
INTENDED USE specimen, and are possibly masking the bilirubin reaction. pH range. Colors range from orange to yellow and green 15 mg/dL
(PRO) seconds buffer and non-
Urine Reagent Strips are firm plastic strips onto which Blood This test is based on the peroxidase-like activity of to blue. The expected range for normal urine specimens (0.075-0.15
reactive
several separate reagent areas are affixed. The test is for hemoglobin which catalyzes the reaction of from newborns is pH 5-7. The expected range for other g/L).
ingredients
the detection of one or more of the following analytes in diisopropylbenzene dihydroperoxide and 3,3',5,5'- normal urine specimens is pH 4.5-8, with an average 2.5% w/w p-
urine: Leukocytes, Glucose, Ketone (Acetoacetic acid), tetramethylbenzidine. The resulting color ranges from result of pH 6. Detects
Urobilino- diethylaminobenza
Bilirubin, Blood, Specific Gravity, Protein, Urobilinogen, orange to green to dark blue. Any green spots or green 60 urobilinogen as
MATERIALS gen
ldehyde; 97.5%
Nitrite, and pH. color development on the reagent area within 60 seconds low as 0.2-1.0
Materials Provided seconds w/w buffer and
is significant and the urine specimen should be examined (URO) mg/dL (3.5-17
1. Strips Bottle non-reactive
SUMMARY further. Blood is often, but not invariably, found in the µmol/L).
2. Package insert ingredients
Urine undergoes many changes during states of disease urine of menstruating females. The significance of a trace Materials Required But Not Provided Detects sodium
or body dysfunction before blood composition is altered reading varies among patients and clinical judgment is 1. Specimen collection container nitrite as low as
to a significant extent. Urinalysis is a useful procedure as required in these specimens. 4.5% w/w p-
2. Timer 0.05-0.1 mg/dL
an indicator of health or disease, and as such, is a part of Specific Gravity: This test is based on the apparent pKa arsanilic acid;
Nitrite 60 in urine with a
routine health screening. Urine Reagent Strips can be change of certain pretreated polyelectrolytes in relation REAGENTS AND PERFORMANCE CHARACTERISTICS 95.5% w/w non-
Based on the dry weight at the time of impregnation, the (NIT) seconds low specific
used in general evaluation of health, and aids in the to ionic concentration. In the presence of an indicator, reactive
concentrations given may vary within manufacturing gravity and less
diagnosis and monitoring of metabolic or systemic colors range from deep blue-green in urine of low ionic ingredients
than 30 mg/dL
diseases that affect kidney function, endocrine disorders concentration to green and yellow-green in urine of tolerances. The following table below indicates read
times and performance characteristics for each ascorbic acid.
and diseases or disorders of the urinary tract. increasing ionic concentration. Randomly collected urine
parameter. 0.5% w/w methyl
may vary in specific gravity from 1.003-1.035 Twenty-four Permits the
PRINCIPLE AND EXPECTED VALUES red sodium salt;
hour urine from healthy adults with normal diets and Read quantitative
Leukocytes: This test reveals the presence of granulocyte Reagent Composition Description 5% w/w
fluid intake will have a specific gravity of 1.016-1.022. In Time 60 differentiation
esterases. The esterases cleave a derivatized pyrazole pH bromthymol blue;
cases of severe renal damage, the specific gravity is fixed 1.5% w/w glucose seconds of pH values
amino acid ester to liberate derivatized hydroxy 94.5% w/w non-
at 1.010, the value of the glomerular filtrate. oxidase; 0.5% w/w within the range
pyrazole. This pyrazole then reacts with a diazonium salt reactive
Protein: This reaction is based on the phenomenon peroxidase; 10.0% Detects glucose of 5-9.
to produce a beige-pink to purple color. Normal urine Glucose 30 ingredients
known as the "protein error” of pH indicators where an w/w potassium as low as 50-
specimens generally yield negative results. Trace results 0.5% w/w
indicator that is highly buffered will change color in the (GLU) seconds iodide; 75.0% w/w 100 mg/dL (2.5-
may be of questionable clinical significance. When trace buffer; 13.0% w/w 5 mmol/L). derivatized pyrrole Detects
results occur, it is recommended to retest using a fresh presence of proteins (anions) as the indicator releases amino acid ester; leukocytes as
hydrogen ions to the protein. At a constant pH, the non-reactive Leucocyte
specimen from the same patient. Repeated trace and 120 0.4% w/w low as 9-
development of any green color is due to the presence of ingredients - es
positive results are of clinical significance. seconds diazonium salt; 15 white blood
protein. Colors range from yellow to yellow-green for Detects (LEU)
Glucose: This test is based on the enzymatic reaction that 32% w/w buffer; cells Leu/µL in
negative results and green to green-blue for positive Ketone 40 5% w/w sodium acetoacetic acid
occurs between glucose oxidase, peroxidase and 67.1% w/w non- clinical urine.
results. 1-14 mg/dL of protein may be excreted by a nitroprusside; 95% as low as 2.5-
chromogen. Glucose is first oxidized to produce gluconic (KET) seconds reactive ingredients
normal kidney. A color matching any block greater than w/w buffer 5 mg/dL (0.25-
acid and hydrogen peroxide in the presence of glucose
trace indicates significant proteinuria. For urine with high 0.5 mmol/L).
oxidase. The hydrogen peroxide reacts with potassium The performance characteristics of the Urine Reagent
specific gravity, the test area may most closely match the 0.5 % w/w 2, 4-
iodide chromogen in the presence of peroxidase. The Strips have been determined in both laboratory and
trace color block even though only normal dichloroaniline Detects bilirubin
extent to which the chromogen is oxidized determines Bilirubin 30 clinical tests. Parameters of importance to the user are
concentrations of protein are present. Clinical judgment diazonium salt; as low as 0.4-1.0
the color which is produced, ranging from green to brown. sensitivity, specificity, accuracy and precision. Generally,
is required to evaluate the significance of trace results. (BIL) Seconds 99.5% w/w buffer mg/dL
Low amounts of glucose are normally excreted in urine.3 this test has been developed to be specific for the
Urobilinogen: This test is based on a modified Ehrlich and non-reactive (6.8-17 µmol/L).
Glucose concentrations as low as 100 mg/dL, read at 30 parameters to be measured with the exceptions of the
reaction between p-diethylaminobenzaldehyde and ingredients
seconds, may be considered abnormal if results are interferences listed. Please refer to the Limitations
urobilinogen acid in strongly acidic medium to produce a 4% w/w 3,3’,5,5’- Detects free
consistent. section in this package insert.
pink color. Urobilinogen is one of the major compounds tetramethylbenzidi hemoglobin as
Ketone: This test is based on ketones reacting with Interpretation of visual results is dependent on several
produced in heme synthesis and is a normal substance in ne (TMB); 6% w/w low as 0.018-
nitroprusside and acetoacetic acid to produce a color factors: the variability of color perception, the presence or
urine. The expected range for normal urine with this test Blood 60 diisopropylbenzen 0.060 mg/dL or
change ranging from light pink for negative results to a absence of inhibitory factors, and the lighting conditions
is 0.2-1.0 mg/dL (3.5-17 µmol/L). A result of 2.0 mg/dL e 5-10 Ery/µL in
darker pink or purple color for positive results. Ketones (BLO) seconds when the strip is read. Each color block on the chart
(35 mmol/L) may be of clinical significance, and the dihydroperoxide; urine specimens
are normally not present in urine. Detectable ketone corresponds to a range of analyte concentrations.
patient specimen should be further evaluated. 90% w/w buffer with ascorbic
levels may occur in urine during physiological stress
Nitrite: This test depends upon the conversion of nitrate and non-reactive acid content of
conditions such as fasting, pregnancy and frequent
to nitrite by the action of Gram-negative bacteria in the ingredients <50 mg/dL.
strenuous exercise. In starvation diets, or in other
urine. In an acidic medium, nitrite in the urine reacts with
PRECAUTIONS with an absorbent material (e.g. a paper towel) to Ketone: The test does not react with acetone or β- than 0.05 mg/dL nitrite ions. The sensitivity of this test is
 For in vitro diagnostic and professional use only. avoid mixing chemicals from adjacent reagent areas hydroxybutyrate. Urine specimens of high pigment, and reduced for urine specimens with highly buffered alkaline
 Do not use after the expiration date. and/or soiling hands with urine. See illustration 2 other substances containing sulfhydryl groups urine or with high specific gravity. A negative result does
 The strip should remain in the closed bottle until use. below. occasionally give reactions up to and including trace (+). not at any time preclude the possibility of bacteriuria.
 Do not touch the reagent areas of the strip. 3. Compare the reagent areas to the corresponding color Bilirubin: Bilirubin is absent in normal urine, so any Negative results may occur in urinary tract infections
 Discard any discolored strips that may have blocks on the canister label at the specified times. positive result, including a trace positive, indicates an from organisms that do not contain reductase to convert
deteriorated. Hold the strip close to the color blocks and match underlying pathological condition and requires further nitrate to nitrite; when urine has not been retained in the
 All specimens should be considered potentially carefully. See illustration 3 below. investigation. Reactions may occur with urine containing bladder for a sufficient length of time (at least 4 hours)
hazardous and handled in the same manner as an Note: Results may be read up to 2 minutes after the large doses of chlorpromazine or rifampen that might be for reduction of nitrate to nitrite to occur; when receiving
infectious agent. specified times. mistaken for positive bilirubin.The presence of bilirubin- antibiotic therapy or when dietary nitrate is absent.
1 2 3
 The used strip should be discarded according to local derived bile pigments may mask the bilirubin reaction. PH: If the procedure is not followed and excess urine
regulations after testing. This phenomenon is characterized by color development remains on the strip, a phenomenon known as “run-
on the test patch that does not correlate with the colors over” may occur, in which the acid buffer from the
 Never smoke, drink, or eat in the assay laboratory.
on the color chart. Large concentrations of ascorbic acid protein reagent will run onto the pH area, causing the pH
 Wear protective clothing and disposable gloves when
may decrease sensitivity. result to appear artificially low.pH readings are not
dealing with samples and reagents. Wash hands after
Blood: A uniform blue color indicates the presence of affected by variations in urinary buffer concentration.
performing the test.
myoglobin, hemoglobin orhemolyzed erythrocytes.8 Leukocytes: The result should be read between 60-120
 Handle specimens as though they contain infectious
Scattered or compacted blue spots indicate intact seconds to allow for complete color development. The
agents.
erythrocytes. To enhance accuracy, separate color scales intensity of the color that develops is proportional to the
 Humidity and temperature can adversely affect results.
are provided for hemoglobin and for erythrocytes. number of leukocytes present in the urine specimen.
 Do not use the test if printing is unclear and/or expiry INTERPRETATION OF RESULTS
Positive results with this test are often seen with urine High specific gravity or elevated glucose concentrations
date is missing. Results are obtained by direct comparison of the color
from menstruating females. It has been reported that (≥ 2,000 mg/dL) may cause test results to be artificially
blocks printed on the canister label. The color blocks
STORAGE AND STABILITY urine of high pH reduces sensitivity, while moderate to low. The presence of cephalexin, cephalothin, or high
represent nominal values; actual values will vary close to
Store as packaged in the closed canister either at room high concentration of ascorbic acid may inhibit color concentrations of oxalic acid may also cause test results
the nominal values. In the event of unexpected or
temperature (15-30°C). Keep out of direct sunlight. The formation. Microbial peroxidase, associated with urinary to be artificially low. Tetracycline may cause decreased
questionable results, the following steps are
strip is stable through the expiration date printed on the tract infection, may cause a false positive reaction. The reactivity, and high levels of the drug may cause a false
recommended; confirm that the specimens have been
canister label. Do not remove the desiccant. Remove only test is slightly more sensitive to free hemoglobin and negative reaction. High urinary protein may diminish the
tested within the expiration date printed on the canister
enough strips for immediate use. Replace cap myoglobin than to intact erythrocytes. intensity of the reaction color. This test will not react with
label, compare results with known positive and negative
immediately and tightly. DO NOT FREEZE. Do not use Specific Gravity: Ketoacidosis or protein higher than erythrocytes or bacteria common in urine.
controls and repeat the test using a new strip. If the
beyond the expiration date. 300 mg/dL may cause elevated results. Results are not
problem persists, discontinue using the strip immediately BIBLIOGRAPHY
Note: Once the canister has been opened, the affected by non-ionic urine components such as glucose.
remaining strips are stable for up to 3months.
and contact your local distributor.
If the urine has a pH of 7 or greater, add 0.005 to the  Free AH, Free HM. Urinalysis, Critical Discipline of
Stability may be reduced in high humidity conditions. specific gravity reading indicated on the color chart. Clinical Science. CRC Crit. Rev. Clin. Lab. Sci. 3(4): 481-
QUALITY CONTROL
Protein: Any green color indicates the presence of 531, 1972.
For best results, performance of reagent strips should be
SPECIMEN COLLECTION AND PREPARATION protein in the urine. This test is highly sensitive for  Yoder J, Adams EC, Free, AH. Simultaneous Screening
confirmed by testing known positive and negative
A urine specimen must be collected in a clean and dry albumin, and less sensitive to hemoglobin, globulin and for Urinary Occult Blood, Protein, Glucose, and pH.
specimens/controls whenever a new test is performed,
container and tested as soon as possible. Do not mucoprotein. A negative result does not rule out the Amer. J. Med Tech. 31:285, 1965.
or whenever a new canister is first opened. Each
centrifuge. The use of urine preservatives is not presence of these other proteins. False positive results  Shchersten B, Fritz H. Subnormal Levels of Glucose in
laboratory should establish its own goals for adequate
recommended. If testing cannot be done within an hour may be obtained with highly buffered or alkaline urine. Urine. JAMA 201:129-132, 1967.
standards of performance.
after voiding, refrigerate the specimen immediately and Contamination of urine specimens with quaternary  McGarry JD, Lilly. Lecture, 1978: New Perspectives in
let it return to room temperature before testing. LIMITATIONS ammonium compounds or skin cleansers containing the Regulation of Ketogenesis. Diabetes 28: 517-523
Prolonged storage of unpreserved urine at room Note: The Urinalysis Reagent Strips (Urine) may be chlorhexidine produces false positive results8. The urine May, 1978.
temperature may result in microbial proliferation with affected by substances that cause abnormal urine color specimens with high specific gravity may give false  Williamson DH. Physiological Ketoses, or Why Ketone
resultant changes in pH. A shift to alkaline pH may cause such as drugs containing azo dyes (e.g. Pyridium®, Azo negative results. Bodies? Postgrad. Med. J. (June Suppl.): 372-375, 1971.
false positive results with the protein test area. Urine Gantrisin®, Azo Gantanol®), nitrofurantoin (Microdantin®, Urobilinogen: All results lower than 1 mg/dL  Paterson P, et al. Maternal and Fetal Ketone
containing glucose may decrease in pH as organisms Furadantin®), and riboflavin.8 The color development on urobilinogen should be interpreted as normal. A negative Concentrations in Plasma and Urine. Lancet: 862-865;
metabolize the glucose. the test pad may be masked or a color reaction may be result does not at any time preclude the absence of April 22, 1967.
Contamination of the urine specimen with skin cleansers produced that could be interpreted as false results.As urobilinogen. The reagent area may react with interfering  Fraser J, et al. Studies with a Simplified Nitroprusside
containing chlorhexidine may affect protein (and to a with all diagnostic and therapeutic tests, all results must substances known to react with Ehrlich’s reagent, such as Test for Ketone Bodies in Urine, Serum, Plasma and
lesser extent, specific gravity and bilirubin) test results. be considered with other clinical information available to p-aminosalicylic acid and sulfonamides. False negative Milk. Clin. Chem. Acta II: 372-378, 1965.
the physician. results may be obtained if formalin is present. The test  Henry JB, et al. Clinical Diagnosis and Management by
DIRECTIONS FOR USE Glucose: This test is highly specific for glucose. No cannot be used to detect porphobilinogen. Laboratory Methods, 18th Ed. Philadelphia. Saunders.
1. Remove the strip from the closed canister and use it as substance excreted in urine other than glucose is known Nitrite: The test is specific for nitrite and will not react 396-397, 415, 1991.
soon as possible. Immediately close the canister to give a positive result. The reagent area does not react with any other substance normally excreted in urine. Any  Burtis CA, Ashwood ER. Tietz Textbook of Clinical
tightly after removing the required number of strip(s). with ketones, lactose, galactose, fructose or other degree of uniform pink to red color should be interpreted Chemistry 2nd Ed. 2205, 1994.
Completely immerse the reagent areas of the strip in metabolic substances, nor with reducing metabolites of as a positive result, suggesting the presence of nitrite.  Tietz NW. Clinical Guide to Laboratory Tests. W.B.
fresh, well-mixed urine and immediately remove the drugs (e.g. salicylates and nalidixic acid). Sensitivity may Color intensity is not proportional to the number of Saunders Company. 1976.
strip to avoid dissolving the reagents. See illustration 1 be decreased in specimens with high specific gravity bacteria present in the urine specimen. Pink spots or pink
below. (>1.025) and with ascorbic acid concentrations of ≥ 25 edges should not be interpreted as a positive result.
2. While removing the strip from the urine, run the edge mg/dL. High ketone levels ≥ 100 mg/dL may cause false Comparing the reacted reagent area on a white
of the strip against the rim of the urine container to negative results for specimens containing a small amount background may aid in the detection of low nitrite levels,
remove excess urine. Hold the strip in a horizontal of glucose (50-100 mg/dL). which might otherwise be missed. Ascorbic acid above 30
position and bring the edge of the strip into contact mg/dL may cause false negatives in urine containing less
 ATLAS Medical
Ludwig-Erhard Ring 3
15827 Blankenfelde-Mahlow
Germany
Tel: +49 - 33708 – 3550 30
Email: [email protected]
Website: www.atlas-medical.com

PPI1452A01
Rev C (23.10.2021)

Catalogue Number Store at 15 -30°C.

In Vitro diagnostic
Caution
medical device
Contains sufficient Consult
for <n> tests and instructions for
Relative size use (IFU)
Batch code Manufacturer

Do not re-use Use-by date

Manufacturer fax Do not use if

package is
number
damaged
Manufacturer Date of
telephone number Manufacture
Keep away from
Keep dry
sunlight