1150483303 sack medical refuah us u031-103 english insert 102809.doc

Urinalysis Reagent Strips
couples with 1 N-(1-naphthyl) ethylenediamine to produce a pink color. Nitrite is not MATERIALS
pH: If the procedure is not followed and excess urine remains on the strip, a
detectable in normal urine.9 The nitrite area will be positive in some cases of infection, Materials Provided
phenomenon known as “runover” may occur, in which the acid buffer from the protein depending on how long the urine specimens were retained in the bladder prior to reagent will run onto the pH area, causing the pH result to appear artificially low. pH collection. Retrieval of positive cases with the nitrite test ranges from as low as 40% in readings are not affected by variations in urinary buffer concentration. Package Insert
cases where little bladder incubation occurred, to as high as approximately 80% in cases Materials Required But Not Provided
Protein: Any green color indicates the presence of protein in the urine. This test is
where bladder incubation took place for at least 4 hours. highly sensitive for albumin, and less sensitive to hemoglobin, globulin and For rapid detection of multiple analytes in human urine. Leukocytes: This test reveals the presence of granulocyte esterases. The esterases cleave
mucoprotein.8 A negative result does not rule out the presence of these other proteins. For in vitro diagnostic use only. DIRECTIONS FOR USE
a derivatized pyrazole amino acid ester to liberate derivatized hydroxy pyrazole. This False positive results may be obtained with highly buffered or alkaline urine. Allow the strip, urine specimen, and/or controls to reach room temperature
INTENDED USE
pyrazole then reacts with a diazonium salt to produce a beige-pink to purple color. Contamination of urine specimens with quaternary ammonium compounds or skin (15-30ºC) prior to testing.
cleansers containing chlorhexidine may produce false positive results.8 The urine The RefuAH Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative Normal urine specimens generally yield negative results. Trace results may be of questionable clinical significance. When trace results occur, it is recommended to retest 1. Remove the strip from the closed canister and use it as soon as possible. Immediately specimens with high specific gravity may give false negative results. detection of one or more of the following analytes in urine: Glucose, Bilirubin, Ketone using a fresh specimen from the same patient. Repeated trace and positive results are of close the canister tightly after removing the required number of strip(s). Completely Urobilinogen: All results lower than 1 mg/dL urobilinogen should be interpreted as
(Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and immerse the reagent areas of the strip in fresh, well-mixed urine and immediately normal. A negative result does not at any time preclude the absence of urobilinogen. The Leukocytes. The RefuAH Urinalysis Reagent Strips (Urine) are for single use in professional remove the strip to avoid dissolving the reagents. See illustration 1 below. reagent area may react with interfering substances known to react with Ehrlich’s reagent, near-patient (point-of-care) and centralized laboratory locations, and are intended for REAGENTS AND PERFORMANCE CHARACTERISTICS
2. While removing the strip from the urine, run the edge of the strip against the rim of such as p-aminosalicylic acid and sulfonamides.9 False negative results may be obtained professional use only. The strips are intended for use in screening at-risk patients to assist Based on the dry weight at the time of impregnation, the concentrations given may vary the urine container to remove excess urine. Hold the strip in a horizontal position if formalin is present. The test cannot be used to detect porphobilinogen. diagnosis in the following areas: kidney function, urinary tract infections, carbohydrate within manufacturing tolerances. The following table below indicates read times and and bring the edge of the strip into contact with an absorbent material (e.g. a paper Nitrite: The test is specific for nitrite and will not react with any other substance
metabolism (e.g. diabetes mellitus), liver function, acid-base balance and urine performance characteristics for each parameter. towel) to avoid mixing chemicals from adjacent reagent areas and/or soiling hands normally excreted in urine. Any degree of uniform pink to red color should be concentration. The results can be used along with other diagnostic information to rule out interpreted as a positive result, suggesting the presence of nitrite. Color intensity is not certain disease states and to determine if microscopic analysis is needed. The RefuAH Composition
Description
3. Compare the reagent areas to the corresponding color blocks on the canister label at proportional to the number of bacteria present in the urine specimen. Pink spots or pink Urinalysis Reagent Strips (Urine) can be read visually and on RefuAH U120 Urine the specified times. Hold the strip close to the color blocks and match carefully. See edges should not be interpreted as a positive result. Comparing the reacted reagent area on a white background may aid in the detection of low nitrite levels, which might Note: Results may be read up to 2 minutes after the specified times. otherwise be missed. Ascorbic acid above 30 mg/dL may cause false negatives in urine 2, 4-dichloroaniline diazonium Detects bilirubin as low as containing less than 0.05 mg/dL nitrite ions. The sensitivity of this test is reduced for Urine undergoes many changes during states of disease or body dysfunction before Bilirubin
Results may also be read on the RefuAH U120 Urine Analyzer. Refer to the RefuAH urine specimens with highly buffered alkaline urine or with high specific gravity. A blood composition is altered to a significant extent. Urinalysis is a useful procedure as U120 Urine Analyzer Instruction Manual for details. negative result does not at any time preclude the possibility of bacteruria. Negative an indicator of health or disease, and as such, is a part of routine health screening. The results may occur in urinary tract infections from organisms that do not contain RefuAH Urinalysis Reagent Strips (Urine) can be used in general evaluation of health, reductase to convert nitrate to nitrite; when urine has not been retained in the bladder for and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect a sufficient length of time (at least 4 hours) for reduction of nitrate to nitrite to occur; kidney function, endocrine disorders and diseases or disorders of the urinary tract.1,2 Specific
when receiving antibiotic therapy or when dietary nitrate is absent. PRINCIPLE AND EXPECTED VALUES
ingredients; poly (methyl vinyl 1.030. Results correlate with Leukocytes: The result should be read between 60-120 seconds to allow for complete
Glucose: This test is based on the enzymatic reaction that occurs between glucose
color development. The intensity of the color that develops is proportional to the number oxidase, peroxidase and chromogen. Glucose is first oxidized to produce gluconic acid of leukocytes present in the urine specimen. High specific gravity or elevated glucose and hydrogen peroxide in the presence of glucose oxidase. The hydrogen peroxide reacts concentrations (≥ 2,000 mg/dL) may cause test results to be artificially low. The with potassium iodide chromogen in the presence of peroxidase. The extent to which the presence of cephalexin, cephalothin, or high concentrations of oxalic acid may also chromogen is oxidized determines the color which is produced, ranging from green to cause test results to be artificially low. Tetracycline may cause decreased reactivity, and INTERPRETATION OF RESULTS
brown. Glucose should not be detected in normal urine. Small amounts of glucose may high levels of the drug may cause a false negative reaction. High urinary protein may be excreted by the kidney.3 Glucose concentrations as low as 100 mg/dL may be Results are obtained by direct comparison of the color blocks printed on the canister diminish the intensity of the reaction color. This test will not react with erythrocytes or considered abnormal if results are consistent. bromthymol blue; non-reactive differentiation of pH values label. The color blocks represent nominal values; actual values will vary close to the Bilirubin: This test is based on azo-coupling reaction of bilirubin with diazotized
nominal values. In the event of unexpected or questionable results, the following steps BIBLIOGRAPHY
dichloroaniline in a strongly acidic medium. Varying bilirubin levels will produce a are recommended; confirm that the strips have been tested within the expiration date 1. Free AH, Free HM. Urinalysis, Critical Discipline of Clinical Science. CRC Crit. pinkish-tan color proportional to its concentration in urine. In normal urine, no bilirubin is printed on the canister label, compare results with known positive and negative controls Rev. Clin. Lab. Sci. 3(4): 481-531, 1972. detectable by even the most sensitive methods. Even trace amounts of bilirubin require Urobilinogen
and repeat the test using a new strip. If the problem persists, discontinue using the strip 2. Yoder J, Adams EC, Free, AH. Simultaneous Screening for Urinary Occult Blood, further investigation. Atypical results (colors different from the negative or positive color immediately. Please contact Customer Support at 1-800-521-1635, 24 hours a day, 365 Protein, Glucose, and pH. Amer. J. Med Tech. 31:285, 1965. blocks shown on the color chart) may indicate that bilirubin-derived bile pigments are 3. Shchersten B, Fritz H. Subnormal Levels of Glucose in Urine. JAMA 201:129-132, 1967. p-arsanilic acid;
present in the urine specimen, and are possibly masking the bilirubin reaction. QUALITY CONTROL
4. McGarry JD, Lilly. Lecture, 1978: New Perspectives in the Regulation of Ketone: This test is based on ketones reacting with nitroprusside and acetoacetic acid to
seconds ethylenediamine; non-reactive low specific gravity and less For best results, performance of reagent strips should be confirmed by testing known Ketogenesis. Diabetes 28: 517-523 May, 1978. produce a color change ranging from light pink for negative results to a darker pink or positive and negative specimens/controls whenever a new canister is first opened, at the 5. Williamson DH. Physiological Ketoses, or Why Ketone Bodies? Postgrad. Med. J. purple color for positive results. Ketones are normally not present in urine. Detectable derivatized pyrrole amino acid Detects leukocytes as low as beginning of each new day of testing, test results seem inaccurate, or a new operator Leukocytes
ketone levels may occur in urine during physiological stress conditions such as fasting, 6. Paterson P, et al. Maternal and Fetal Ketone Concentrations in Plasma and Urine. uses the analyzer if applicable. Each laboratory should establish its own goals for pregnancy and frequent strenuous exercise.4-6 In starvation diets, or in other abnormal adequate standards of performance. For help with any additional questions or issues, carbohydrate metabolism situations, ketones appear in the urine in excessively high The performance characteristics of the RefuAH Urinalysis Reagent Strips (Urine) have please contact Customer Support at 1-800-521-1635, 24 hours a day, 365 days a year. 7. Fraser J, et al. Studies with a Simplified Nitroprusside Test for Ketone Bodies in concentration before serum ketones are elevated.7 Urine, Serum, Plasma and Milk. Clin. Chem. Acta II: 372-378, 1965. been determined in both laboratory and clinical tests. Parameters of importance to the LIMITATIONS
Specific Gravity: This test is based on the apparent pKa change of certain pretreated
8. Henry JB, et al. Clinical Diagnosis and Management by Laboratory Methods, 20th Ed. user are sensitivity, specificity, accuracy and precision. Generally, this test has been Note: As with all laboratory tests, diagnostic and therapeutic decisions should not be
polyelectrolytes in relation to ionic concentration. In the presence of an indicator, colors Philadelphia. Saunders. 371-372, 375, 379, 382, 385, 2001. developed to be specific for the parameters to be measured with the exceptions of the based on any single result or method and must be considered with other clinical range from deep blue-green in urine of low ionic concentration to green and yellow-green in 9. Tietz NW. Clinical Guide to Laboratory Tests. W.B. Saunders Company. 1976. interferences listed. Please refer to the Limitations section in this package insert. urine of increasing ionic concentration. Randomly collected urine may vary in specific 10. Burtis CA, Ashwood ER. Tietz Textbook of Clinical Chemistry 2nd Ed. 2205, 1994. Interpretation of visual results is dependent on several factors: the variability of color The RefuAH Urinalysis Reagent Strips (Urine) may be affected by substances that cause gravity from 1.003-1.035.8 Twenty-four hour urine from healthy adults with normal diets perception, the presence or absence of inhibitory factors, and the lighting conditions when the abnormal urine color such as drugs containing azo dyes (e.g. Pyridium , Azo Gantrisin , and fluid intake will have a specific gravity of 1.016-1.022.8 In cases of severe renal damage, strip is read. Each color block on the chart corresponds to a range of analyte concentrations. Azo Gantanol ), nitrofurantoin (Microdantin , Furadantin ), and riboflavin.8 The color CLIA Category: Waived
the specific gravity is fixed at 1.010, the value of the glomerular filtrate. PRECAUTIONS
development on the test pad may be masked or a color reaction may be produced that could Blood: This test is based on the peroxidase-like activity of hemoglobin which catalyzes
the reaction of diisopropylbenzene dihydroperoxide and 3,3',5,5'-tetramethylbenzidine. • For in vitro diagnostic use only. Do not use after the expiration date. Glucose: The reagent area does not react with lactose, galactose, fructose or other
The resulting color ranges from orange to green to dark blue. Any green spots or green • The strip should remain in the closed canister until use. metabolic substances, nor with reducing metabolites of drugs (e.g. salicylates and color development on the reagent area within 60 seconds is significant and the urine • Do not touch the reagent areas of the strip. nalidixic acid). Sensitivity may be decreased in specimens with high specific gravity specimen should be examined further. Blood is often, but not invariably, found in the • Discard any discolored strips that may have deteriorated. (>1.025) and with ascorbic acid concentrations of ≥ 25 mg/dL. High ketone levels urine of menstruating females. The significance of a trace reading varies among • All specimens should be considered potentially hazardous and handled in the same ≥ 100 mg/dL may cause false negative results for specimens containing a small amount patients and clinical judgment is required in these specimens. pH: This test is based on a double indicator system which gives a broad range of colors
The used strip should be discarded according to local regulations after testing. Bilirubin: Bilirubin is absent in normal urine, so any positive result, including a trace
covering the entire urinary pH range. Colors range from orange to yellow and green to blue. STORAGE AND STABILITY
positive, indicates an underlying pathological condition and requires further The expected range for normal urine specimens from newborns is pH 5-7. 9 The expected Store as packaged in the closed canister either at room temperature or refrigerated investigation. Reactions may occur with urine containing large doses of chlorpromazine range for other normal urine specimens is pH 4.5-8, with an average result of pH 6. 9 (2-30°C or 36-86°F). Keep out of direct sunlight. The strip is stable through the or rifampen that might be mistaken for positive bilirubin.9 The presence of Protein: This reaction is based on the phenomenon known as the "protein error” of pH
expiration date printed on the canister label. Do not remove the desiccant. Remove only bilirubin-derived bile pigments may mask the bilirubin reaction. This phenomenon is indicators where an indicator that is highly buffered will change color in the presence of enough strips for immediate use. Replace cap immediately and tightly. DO NOT
characterized by color development on the test patch that does not correlate with the proteins (anions) as the indicator releases hydrogen ions to the protein. At a constant pH, FREEZE. Do not use beyond the expiration date.
colors on the color chart. Large concentrations of ascorbic acid may decrease sensitivity. the development of any green color is due to the presence of protein. Colors range from Note: Once the can ister has been opened, the remain in g strip s are stable for up Ketone: The test does not react with acetone or β-hydroxybutyrate.8 Urine specimens of
yellow to yellow-green for negative results and green to green-blue for positive results. to 3 months. Stability may be reduced in high humidity conditions. high pigment, and other substances containing sulfhydryl groups may occasionally give 1-14 mg/dL of protein may be excreted by a normal kidney.10 A color matching any reactions up to and including trace (±).9 block greater than trace indicates significant proteinuria. Clinical judgment is required to SPECIMEN COLLECTION AND PREPARATION
Specific Gravity: Ketoacidosis or protein higher than 300 mg/dL may cause elevated results.
evaluate the significance of trace results. A urine specimen must be collected in a clean and dry container and tested as soon as Results are not affected by non-ionic urine components such as glucose. If the urine has a pH Urobilinogen: This test is based on a modified Ehrlich reaction between
possible. Do not centrifuge. The use of urine preservatives is not recommended. If of 7 or greater, add 0.005 to the specific gravity reading indicated on the color chart. p-diethylaminobenzaldehyde and urobilinogen in strongly acidic medium to produce a testing cannot be done within an hour after voiding, refrigerate the specimen Blood: A uniform blue color indicates the presence of myoglobin, hemoglobin or
pink color. Urobilinogen is one of the major compounds produced in heme synthesis and immediately and let it return to room temperature before testing. hemolyzed erythrocytes.8 Scattered or compacted blue spots indicate intact erythrocytes. is a normal substance in urine. The expected range for normal urine with this test is Prolonged storage of unpreserved urine at room temperature may result in microbial To enhance accuracy, separate color scales are provided for hemoglobin and for 0.2-1.0 mg/dL (3.5-17 µmol/L). 8 A result of 2.0 mg/dL (35 µmol/L) may be of clinical proliferation with resultant changes in pH. A shift to alkaline pH may cause false erythrocytes. Positive results with this test are often seen with urine from menstruating significance, and the patient specimen should be further evaluated. positive results with the protein test area. Urine containing glucose may decrease in pH females. It has been reported that urine of high pH reduces sensitivity, while moderate to Nitrite: This test depends upon the conversion of nitrate to nitrite by the action of Gram
high concentration of ascorbic acid may inhibit color formation. Microbial peroxidase, negative bacteria in the urine. In an acidic medium, nitrite in the urine reacts with Contamination of the urine specimen with skin cleansers containing chlorhexidine may associated with urinary tract infection, may cause a false positive reaction. The test is p-arsanilic acid to form a diazonium compound. The diazonium compound in turn affect protein (and to a lesser extent, specific gravity and bilirubin) test results. slightly more sensitive to free hemoglobin and myoglobin than to intact erythrocytes.

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