Urine strips

DIAGNOST CS
INTENDED USE
The intended use of the reagent strips are for the in-vitro
determination of Glucose, Bilirubin, Ketone, Specific Gravity,
Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes
in Urine.
SUMMARY
Urinalysis by the "Dip & Read" Method is widely practiced
as a rapid chemical analysis in the diagnosis of various dis-
eases. These reagent strips consists of plastic strips affixed
with reagent impregnated areas for Glucose, Bilirubin,
Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen,
Nitrite, and Leukocytes. Determination of relative quanti-
ties can be made by visual comparison to a color chart
provided or by use of a reflectance meter. Use of such
reagent strips has made measurement of multiple urine
constituents and use for routine diagnosis and group exami-
tainer, which has a desiccant. It should be kept at room temperature (between 5-25 degrees centigrade), and away STORAGE CONDITIONS & GENERAL
from direct sunlight. Do not use after the expiration date PRECAUTIONS AND WARNINGS
shown. Good laboratory practice and Universal precau- For in-vitro use only. As with all laboratory tests, definitive tions for handling biological specimens should be observed.
diagnostic or therapeutic decisions should not be based on Specimens and waste materials should be properly disinfec- any single result or method. The effects of drugs or ted before disposal. Once a test has been started all subse- metabolites on the individual test are not known in all quent steps should be completed without interruptions and cases. Reagent strips should be stored in their original con- 10 PARAMETER REAGENT STRIPS FOR URINALYSIS 10 PARAMETER REAGENT STRIPS FOR URINALYSIS
Composition (for 100 strips)
Bilirubin
Urobilinogen
Specific Gravity
Leukocytes
Testing Procedures
Ketones- Normal urine specimens ordinarily yield negative results.
However, fasting or overexcercise may cause a significant amount of
Correct operating procedures and measurement time is required to obtain accurate results.
1. Collect FRESH,WELL-MIXED, UNCENTRIFUGED urine specimen in Specific Gravity- Normal specific gravity is primarily influenced by
a clean dry container. Mix well immediately before testing.
the electrolytes and nitrogenous waste products, e.g. Urea and creat- 2. Remove only as many strips as necessary from the container and mine dissolved in urine. The first morning specimen should have a spe- reseal the closure immediately after removing the strips. It is impor- cific gravity between 1.015 and 1.025. Adults random specimen, 1.005- tant to keep the remaining strips dry. Do not touch the test areas of 1.030 (highest in the morning). Newborns random specimen, 1.002- the strip. Inspect the strips. If the reagent areas are discolored or 1.004. In severe renal damage the specific gravity is fixed at 1.010, the 3. Dip the test strip into the urine for no more then 1 second, making Blood- The significance of trace reaction may very among patients, and clin-
sure all the reagent areas have contacted the urine specimen.
ical judgement is required for individual assessment. Development of green 4. Remove the strip and gently remove excess urine by running the spots (Intact erythrocytes) or green color (free hemoglobin/myoglobin) on edge of the strip against the rim of the urine container.
the reagent area within 60 seconds indicates the need for further investiga- 5. Hold the strip in a horizontal position to prevent mixing of chemical tion. Blood is often, but not always, found in the urine of menstruating from adjacent reagent areas and/or contaminating the hands with females. The test is highly sensitive to hemoglobin and is slightly less so to intact red blood cells, and thus complements microscopic examination.
6. Properly orient the strip near the appropriate color chart on the PH – Normal urine is around pH 6 and acidic. It varies from pH 4.5
container label. At the times specified, read the results carefully under good lighting or with the appropriate instrument compatible Protein – Normally no protein is detectable in urine, although a
minute amount is excreted by the normal kidney. Pathogenic protein-uria generally gives values above 30mg/dl and is persistent.
Expected Values
Urobilinogen – The normal urobilinogen range is 0.1 to 1.0 Ehrlich
Glucose- A small amount of Glucose may be detected in normal
urine. The concentration is 2-20 mg/dl and the daily amount of excre- Nitrite – Normally no nitrite is detectable in urine. (A false negative
may occur due to fasting, since there is insufficient distary nitrate to Bilirubin- Even a small amount of bilirubin detected in urine should be
convert to nitrite by Gram negative bacteria.) Leukocytes – Normal urine specimens ordinarily yield negative results.
PLEASE CONTACT:
WORLDWIDE DIAGNOSTICS
P.O. Box 656 • Ridgefield, CT 06877 • USA
Web: http://www.worldwidediagnostics.com
E-mail: [email protected]
10 PARAMETER REAGENT STRIPS FOR URINALYSIS
INTENDED USE
The intended use of the reagent strips are for the in-vitro determination of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH,Protein, Urobilinogen, Nitrite, and Leukocytes in Urine.
Urinalysis by the "Dip & Read" Method is widely practiced as a rapid chemical analysis in the diagnosis of various diseases. Thesereagent kits consist of plastic strips affixed with reagent impregnated areas for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH,Protein, Urobilinogen, Nitrite, and Leukocytes. Determination of relative quantities can be made by visual comparison to a color chartprovided or by use of a reflectance meter. Use of such reagent strips has made measurement of multiple urine constituents and use forroutine diagnosis and group examinations all the more easier.
STORAGE CONDITIONS & GENERAL PRECAUTIONS AND WARNINGS
For in-vitro use only. As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on any single resultor method. The effects of drugs or metabolites on the individual test are not known in all cases. Reagent strips should be stored intheir original container, which has a desiccant. It should be kept at room temperature (between 5-25 degrees centigrade), and awayfrom direct sunlight. Do not use after the expiration date shown. Good laboratory practice and Universal precautions for handling bio-logical specimens should be observed. Specimens and waste materials should be properly disinfected before disposal. Once a test hasbeen started all subsequent steps should be completed without interruptions and within the recommended time limits.
COMPOSITION (FOR 100 STRIPS)
Bilirubin
Urobilinogen
Specific Gravity
Leukocytes
TESTING PROCEDURES
Correct operating procedures and measurement time is required to obtain accurate results.
1. Collect FRESH,WELL-MIXED, UNCENTRIFUGED urine specimen in a clean dry container. Mix well immediately before testing.
2. Remove only as many strips as necessary from the container and reseal the closure immediately after removing the strips. It is important to keep the remaining strips dry. Do not touch the test areas of the strip. Inspect the strips. If the reagent areas are dis-colored or darkened do not use the strips.
3. Dip the test strip into the urine for no more then 1 second, making sure all the reagent areas have contacted the urine specimen.
4. Remove the strip and gently remove excess urine by running the edge of the strip against the rim of the urine container.
5. Hold the strip in a horizontal position to prevent mixing of chemical from adjacent reagent areas and/or contaminating the hands with 6. Properly orient the strip near the appropriate color chart on the container label. At the times specified, read the results carefully under good lighting or with the appropriate instrument compatible with the strips.
EXPECTED VALUES
Glucose- A small amount of Glucose may be detected in normal urine. The concentration is 2-20 mg/dl and the daily amount of excre-
tion is 40-80mg. Bilirubin- Even a small amount of bilirubin detected in urine should be considered as significant. Ketones- Normal
urine specimens ordinarily yield negative results. However, fasting or overexcercise may cause a significant amount of Ketones. Specific
Gravity- Normal specific gravity is primarily influenced by the electrolytes and nitrogenous waste products, e.g. Urea and creatmine dis-
solved in urine. The first morning specimen should have a specific gravity between 1.015 and 1.025. Adults random specimen, 1.005-1.030
(highest in the morning). Newborns random specimen, 1.002- 1.004. In severe renal damage the specific gravity is fixed at 1.010, the
value of the glomeruler filtrate. Blood- The significance of trace reaction may very among patients, and clinical judgement is required for
individual assessment. Development of green spots (Intact erythrocytes) or green color (free hemoglobin/myoglobin) on the reagent area
within 60 seconds indicates the need for further investigation. Blood is often, but not always, found in the urine of menstruating females.
The test is highly sensitive to hemoglobin and is slightly less so to intact red blood cells, and thus complements microscopic examination.
PH – Normal urine is around pH 6 and acidic. It varies from pH 4.5 to 8.5 depending on diet content. Protein – Normally no protein
is detectable in urine, although a minute amount is excreted by the normal kidney. Pathogenic proteinuria generally gives values above
30mg/dl and is persistent. Urobilinogen – The normal urobilinogen range is 0.1 to 1.0 Ehrlich units per 100ml. Nitrite – Normally no
nitrite is detectable in urine. (A false negative may occur due to fasting, since there is insufficient distary nitrate to convert to nitrite by
Gram negative bacteria.) Leukocytes – Normal urine specimens ordinarily yield negative results.
LIMITATIONS
Glucose
Specific gravity greater than 1.020, particularly in combination with high pH, may reduce sensitivity of the test. Ascorbinc acid at concen-
trations of 50-75 mg/dl or higher may also cause false negatives for specimens containing small mounts of glucose.
Bilirubin
Ascorbic acid at concentrations of 25mg/dl or greater may cause false negatives. Uric acid and nitrite may also cause false negatives.
Metabolites of drugs such as Pyridium and Selenium, which give a color at low pH, may cause false positives. Urobilinogen and other
bilirubin-derived bile pigments may give spurious results.
Ketones
Positive results (trace or less) may occur with highly pigmented urine specimens or those containing large amounts of levodops metabo-
lites. Detectable levels of ketone may occur in urine during physiological stress conditions such as fasting, pregnancy and frequent stren-
uous exercise in ketoscidosis, starvation or with other abnormalities of carbohydrate or lipid metabolism, ketones may appear in urine
in large amounts before serum ketone is elevated. Some high specific gravity-low pH urines may give reactions up to and including trace
(5mg/dl). Clinical judgement is needed to determine the significance of reactions up to and including trace.
Specific Gravity
Highly buffered and alkaline urine lowers the value. Urine with lower pH, and proteinuria increases the value of specific gravity. X-ray
contrast media and urine preservatives also increase specific gravity.
Blood
Elevated specific gravity or elevated protein may reduce the reactivity of the blood test. Certain oxidizing contaminants, such as hypo-
chiorite or chlorine, may produce false positive results. Microbial peroxidase associated with urinary tract infection may cause a false
positive result. Ascorbic acid concentrations of 40 mg/dl and higher may cause false negatives at the trace levels.
PH
If proper procedure is not followed and a drop of urine remains on the strip, it may wash the acid buffer from the neighboring protein
reagent onto the pH area and change the pH reading to an acid pH if the urine being tested is originally neutral or alkaline. This is
called the "run-over" phenomenon.
Protein
Urine with elevated specific gravity and acid urine with a pH less than 3 will cause false negative results. False positive results may be
found in strongly basic urine (pH 9), during therapy with quinine, quinidine, chlorquine, trimethoprim, or phenazopyridine, when infusion
of polyvinylpyrrolidone (blood substitutes) are administered, or when residues of disinfectants containing quaternary ammonium com-
pounds or chlorhexidine are present in the urine vessel.
Urobitinogen
The absence of urobinogen in the specimen cannot be determined. The test will react with interfering substances known to react with
Ehrtich’s reagent, such as para-aminosaticylic acid. The test is not a reliable method for the detection of porphobilinogen. Drugs con-
taining azo-Gantrisin may give a masking golden color. Urine with a high level of bilirubin causes the development of green color.
Nitrite
Increased diuresis with attendant frequent micturition can lead to a negative nitrite finding because the urine does not remain in the
bladder long enough. Excessive dilution of the urine and nocturia can be prevented by limiting fluid intake during the evening before the
test. As nitrate can be absorbed only from the food ingested and subsequently passed into the urine, false negative results for the nitrite
test may be found particularly during starvation or fasting period, when the patient is being fed intravenously or when the diet contains
no vegetables. The urine specimen should be as fresh as possible; midstream urine is not necessary. Urine that has been stored for long
periods of time (more than 4 hours) is likely to give a false negative or positive result. The latter can be shown to be due to bacterial
contamination. Pink spots or edges should not be interpreted as a positive result. Any degree of uniform pink to red color develop-
ment should be interpreted as a positive nitrite test suggesting the presence of 100,000 or more organisms per ml, but color develop-
ment is not proportional to the number of bacteria present. A negative result does not in itself prove that there is no significant bacte-
ria. Negative results may occur when urinary tract infections are caused by organisms which do not contain reductase to convert
nitrate to nitrite, when urine has not been retained in the bladder long enough (4 hours or more) for reduction of nitrate to nitrite to
occur, or when nitrate is absent, even if organisms containing reductase are present and bladder incubation is ample. Sensitivity of the
test is reduced for urines with high specific gravity. Ascorbic acid at 25mg/dl or greater may cause false negative results in urine contain-
ing nitrate at 0.03 mg/dl or less.
Leukocytes
Glucose at more than 500 mg/dl and protein in excess of 500mg/dl diminish the intensity of the color reaction, as can cephalexin if
administered in high daily doses. Formaldehyde can give false positive results.
SPECIFICITY AND SENSITIVITY OF EACH TEST
Glucose- This test reacts with beta-D-glucose only and should not be affected by other reducing sugars (sucrose, lactose, and fructose).
The sensitivity is at 75-125mg/dl. Bilirubin – This test reacts sensitively to direct bilirubin. The sensitivity is 0.4-0.8 mg/dl. Ketones –
The test is more sensitive to acetoacetic acid than to acetone, but should not react with beta-hydroxbutric acid. The reaction to ace-
tone is 1/10 of it to acetoacetic acid. The sensitivity is at 5-10 mg/dl. Specific Gravity – This test allows determination of specific
gravity between1.0 and 1.03. Blood – The test is more sensitive to hemoglobin and myoglobin than crythrocytes. It is sensitive at 0.05-
0.06 mg/dl of hemoglobin. PH – This test measures pH values generally to within 1 unit in the range of 5-6.5. Protein – this test area
is particularly sensitive to albumin but less sensitive to globulin, Bence-Jones proteins and mucoproteins. The sensitivity is 15-30 mg/dl
of albumin. Urobilinogen – The test is sensitive to urobinogen at 0.1 Ehrich units/dl. For specificity, see section under "limitations" for
possible interfering substances. Nitrite – The test is specific for nitrite. Color intensity does not correlate to number of bacteria how-
ever. The sensitivity is 0.06-0.1 mg/dl of nitrite Ion. Leukocytes – The test reacts with esterase found in urine leukocytes. The sensi-
tivity is equivalent to 5-15 cells/microliter.
PO Box 656
Tel 212 402 6750
Ridgefield, CT 06877, USA
Fax 212 402 6590
e-mail [email protected]
web: www.worldwidediagnostics.com

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