Microsoft word - urine strips_z_rev01.doc

Produktion und Vertrieb von chemisch - technischen Produkten und Laborinstrumenten Gesellschaft m.b.H. A -2351 Wr. Neudorf – IZ-NÖ Süd – Hondastrasse, Obj. M55 – AUSTRIA Phone ++43 (0) 2236 660910-0 Fax ++43 (0) 2236 660910-30 E-Mail: office@dialab.at
URINE STRIPS
This test is based on a double indicator system which gives Ketones are normally not present in urine. Detectable a broad range of colors covering the entire urinary pH range. Ketone levels may occur in urine during physiological Colors range from orange to yellow and green to blue. The stress conditions such as fasting, pregnancy and expected range for normal urine specimens from newborns frequent strenuous exercise. In starvation diets, or in Urine Strip 10ME 100 Ketones, Spec.Grav., Blood, is pH 5-7.4 The expected range for other normal urine other abnormal carbohydrate metabolism situations, specimens is pH 4.5-8, with an average result of pH 6.4 Ketones appear in the urine in excessively high concentration before serum Ketones are elevated.8 Legal’s test principle is the test basis. This test reveals the presence of granulocyte esterases. The esterases cleave a derivatized pyrazole amino acid ester to liberate derivatized hydroxy pyrazole. Then react with a This test is based on the azo-coupling reaction of a diazonium salt to produce a violet dye. The test detects both stable diazonium salt with Urobilinogen in a strongly One kit contains 100 urine strips in a bottle with a
acidic medium to produce a red azo color. Urobilinogen desiccant.
is one of the major compounds produced in haem For in vitro diagnostic use only
synthesis and is a normal substance in urine. The This test depends upon the conversion of nitrate to nitrite by For use by medical professionals only
expected range for normal urine with this test is 0.2-1.0 the action of Gram negative bacteria, or common urinary mg/dL (3.5-17 μmol/L). A result of more than 1.0 mg/dL URINE TEST STRIPS
tract infection causing organisms like E. coli in the urine. It is (17 μmol/L) should be examined further. For the Rapid Determination of Urobilinogen, Glucose, based on the Griess’ test principle. In an acidic medium, Bilirubin, Ketones (Acetoacetic Acid), Specific Gravity, Nitrite in the urine reacts with p-arsanilic acid to form a Blood, pH, Protein, Nitrite, Leukocytes and Ascorbic diazonium compound. The diazonium compound in turn This test is based on the azo-coupling reaction of Acid in human urine. Refer to the label for specific couples with 1 N-(1-naphthyl)- ethylenediamine to produce a Bilirubin with diazotized dichloroaniline in a strongly parameter combination on the product you are using. pink color. Nitrite is not detectable in normal urine. The acidic medium. Varying Bilirubin levels will produce a Nitrite area will be positive in some cases of infection, pinkish-tan color proportional to its concentration in INTENDED USE
depending on how long the urine specimens were retained in urine. In normal urine, no Bilirubin is detectable by even Test result may provide semi-quantitative information the bladder prior to collection. Retrieval of positive cases the most sensitive methods. Even trace amounts of regarding the status of carbohydrate metabolism, kidney with the Nitrite test ranges from as low as 40% in cases Bilirubin require further investigation. Atypical results and liver function, acid-base balance, and urinary tract where little bladder incubation occurred, to as high as (colors different from the negative or positive color infection. The Urinalysis Reagent Strips (Urine) are firm approximately 80% in cases where bladder incubation took blocks shown on the color chart) may indicate that plastic strips onto which several separate reagent areas Bilirubin-derived bile pigments are present in the urine are affixed. Rersults are determined by comparison of specimen, and are possibly masking the Bilirubin test pads on the strip with the colour chart on the label. This reaction is based on the phenomenon known as the TEST PRINCIPLES AND EXPECTED VALUES
"protein error” of pH indicators where an indicator that is highly buffered will change color in the presence of Proteins This test is based on the peroxidase-like activity of (anions) as the indicator releases hydrogen ions to the Hemoglobin which catalyzes the reaction of This test is based on the apparent pKa change of Protein. At a constant pH, the development of any green diisopropylbenzene dihydroperoxide and 3,3',5,5'- certain pretreated polyelectrolytes in relation to ionic color is due to the presence of Protein. High pH (up to 9), tetramethylbenzidine. The resulting color ranges from concentration. In the presence of an indicator, colors chloroquine, tolbutamide, quinine, or quinidine do not affect yellow to green to dark blue. Any green spots or green range from deep blue-green in urine of low ionic this test. Colors range from yellow to yellow-green for color development on the reagent area within 60 concentration to green and yellow-green in urine of negative results and green to green-blue for positive results. seconds is significant and should be examined further. increasing ionic concentration. Randomly collected urine This test is particularly sensitive to albumin. Blood is often, but not invariably, found in the urine of may vary in Specific Gravity from 1.003-1.035. Twenty- menstruating females. The significance of a trace four hour urine from healthy adults with normal diets and reading varies among patients and clinical judgment is fluid intake will have a Specific Gravity of 1.016-1.022. This test is not affected by the presence of Ketones, or the In cases of severe renal damage, the Specific Gravity is pH of the urine. This test is a specific glucose- fixed at 1.010, the value of the glomerular filtrate. oxidase/peroxidase (GOD/POD) reaction based method. S:\pm\allg\inserts\inserts_word\urinestrips\urine strips_z_rev01.doc Produktion und Vertrieb von chemisch - technischen Produkten und Laborinstrumenten Gesellschaft m.b.H. A -2351 Wr. Neudorf – IZ-NÖ Süd – Hondastrasse, Obj. M55 – AUSTRIA Phone ++43 (0) 2236 660910-0 Fax ++43 (0) 2236 660910-30 E-Mail: office@dialab.at STORAGE AND STABILITY
Urobilinogen 60
This test involves decolorization of Tillmann’s reagent. Store as packaged in the closed canister or the sealed tetrafluoroborate; buffer (13.6-17 |imol/L). The presence of Ascorbic Acid causes the color of the pouch either at room temperature or refrigerated (2- test field to change from blue-green to orange. Patients 30°C). Keep out of direct sunlight. The strip is stable with adequate diet may excrete 2-10 mg/dL daily. After through the expiration date printed on the canister label. Bilirubin
2,6-dichloroaniline; buffer Detects Bilirubin as low ingesting large amounts of Ascorbic Acid, levels can be Do not remove the desiccant. Remove only enough strips for immediate use. Replace cap immediately and tightly to avoid questionable results in high humidity Blood (ERY, 60
REAGENTS AND PERFORMANCE
conditions. DO NOT FREEZE. Do not use beyond the CHARACTERISTICS
expiration date. Note: Once the canister has been The following table below indicates read times and opened, the remaining strips are stable for up to 3 performance characteristics for each parameter: months. Strips packaged in the sealed pouch should be used immediately after opening. Stability may be Ascorbic
Acid (ASC)
seconds dichloroplieiioliiidoplienol; as low as 5-10 mg/dL buffer and non-reactive (0.28-0.56 mmol/L). SPECIMEN PREPARATION AND STORAGE
Specific
A urine specimen must be collected in a clean and dry seconds indicator; buffer and non- Specific Gravity container and tested as soon as possible. Do not The performance characteristics of the Urinalysis Reagent Strips (Urine) have been determined in both laboratory and centrifuge. The use of urine preservatives or stabilizers is not recommended. If testing cannot be done within an clinical tests. Parameters of importance to the user are hour after voiding, refrigerate the specimen immediately sensitivity, specificity, accuracy and precision. Generally, this test has been developed to be specific for the parameters to and let it return to room temperature before testing. Do methyl red sodium salt; Permits the quantitative be measured with the exceptions of the interferences listed. not leave urine specimen at room temperature for more seconds bromthymol blue; non- differentiation of pH than 2 hours. Prolonged storage of unpreserved urine at Please refer to the Limitations section in this package insert. Interpretation of visual results is dependent on several room temperature may result in microbial proliferation factors: the variability of color perception, the presence or with resultant changes in pH. Do not expose urine Leukocytes
derivatized pyrrole amino Detects Leukocvtes as specimens to sunlight. Sunlight causes Urobilinogen seconds acid ester; diazonium low as 10-15 white absence of inhibitory factors, and the lighting conditions salt; buffer; non-reactive blood cells (Leu/|aL) in when the strip is read. Each color block on the chart and Bilirubin to oxidize, giving artificially low results. corresponds to a range of analyte concentrations. Contamination of the urine specimen with skin cleansers containing chlorhexidine may affect Protein (and to a Nitrite (NIT)
p-arsanilic acid; N-(l- Detects sodium Nitrite PRECAUTIONS
lesser extent, Specific Gravity and Bilirubin) test results. ethvleiiediamiiie: non- mg/dL in urine with a Detergent or strongly oxidizing disinfectant residues • For in vitro diagnostic use only. Do not use after the found in specimen collection containers may cause false positive results for Glucose, Protein, and Blood. • The strip should remain in the closed canister or the tetrabromophenol blue; Detects albumin as low MATERIALS
seconds buffer and non-reactive as 12-15 mg/dL (0.12- • Do not touch the reagent areas of the strip. Materials provided:
Discard any discolored strips that may have deteriorated. • All specimens should be considered potentially hazardous and handled in the same manner as an • The used strip should be discarded according to local Materials required but not provided:
The desiccant is a silicate-based non-toxic substance. S:\pm\allg\inserts\inserts_word\urinestrips\urine strips_z_rev01.doc Produktion und Vertrieb von chemisch - technischen Produkten und Laborinstrumenten Gesellschaft m.b.H. A -2351 Wr. Neudorf – IZ-NÖ Süd – Hondastrasse, Obj. M55 – AUSTRIA Phone ++43 (0) 2236 660910-0 Fax ++43 (0) 2236 660910-30 E-Mail: office@dialab.at
ASSAY PROCEDURE
INTERPRETATION OF RESULTS
may cause decreased reactivity, and high levels of the • Collect fresh urine in an unused clean and dry vessel. Results are obtained by direct comparison of the color drug may cause a false negative reaction. High urinary Mix well just before test and do not centrifuge. Test blocks printed on the color chart. The color blocks represent Protein (> 500 mg/dL) may diminish the intensity of the the urine as soon as possible after collection. If nominal values; actual values will vary close to the nominal reaction color. This test will not react with Erythrocytes, testing cannot be performed immediately refrigerate values. In the event of unexpected or questionable results, trichomonads or bacteria common in urine. False the specimen and allow it to return to room the following steps are recommended; confirm that the strips positive results may occur in urine containing 20% or have been tested within the expiration date printed on the • Remove a strip from the vial and replace the cap canister label, compare results with known positive and Nitrite: The test is specific for Nitrite and will not react immediately. Inspect the strip. If reagent areas are negative controls and repeat the test using a new strip. If the with any other substance normally excreted in urine. discolored or darkened, do not use the strip. problem persists, discontinue using the strip immediately Any degree of uniform pink to red color should be • Dip the strip into the urine so that all test pads are interpreted as a positive result, suggesting the presence of Nitrite. Color intensity is not proportional to the QUALITY CONTROL
number of Nitrite-forming bacteria present in the urine Draw the edge of the strip along the brim of the vessel For best results, performance of reagent strips should be specimen. Pink spots or pink edges should not be to remove excess urine. But don’t make the test areas confirmed by testing known positive and negative interpreted as a positive result. Comparing the reacted specimens/controls whenever a new test is performed, or reagent area on a white background may aid in the • Turn the strip on its side and tap once on a piece of whenever a new canister from a new lot is first opened. Each detection of low Nitrite levels, which might otherwise be absorbent material to remove any remaining urine. laboratory should establish its own goals for adequate missed. Ascorbic Acid above 30 mg/dL may cause false Excessive urine on the strip may cause the interaction negatives in urine containing less than 0.05 mg/dL of chemicals between adjacent reagent pads, so that Nitrite ions. The sensitivity of this test is reduced for LIMITATIONS
urine specimens with highly buffered alkaline urine or • Read results after 60 seconds for all reagent areas, Urine Strips may be affected by substances that cause with high Specific Gravity. A negative result does not at except Leukocytes after 60-120 seconds, by abnormal urine color such as drugs containing azo dyes any time preclude the possibility of bacteria. Negative comparing the reagent areas to the closest (e.g. Pyridium®, Azo Gantrisin®, Azo Gantanol®), results may occur in urinary tract infections from corresponding color blocks on the color chart. nitrofurantoin (Microdantin®, Furadantin®), and riboflavin. organisms that do not contain reductase to convert The color development on the test pad may be masked or a nitrate to nitrite; when urine has not been retained in the color reaction may be produced that could be interpreted as bladder for a sufficient length of time (at least 4 hours) false results. As with all laboratory tests, diagnostic and for reduction of nitrate to nitrite to occur; when receiving therapeutic decisions should not be based on any single antibiotic therapy or when dietary nitrate is absent. result or method and must be considered with other clinical Protein: This test is highly sensitive for albumin, and less sensitive to Hemoglobin, globulin and mucoprotein. Specific Gravity: Ketoacidosis or Protein concentrations Contamination of urine specimens with quaternary higher than 300 mg/dL may cause elevated results. Results ammonium compounds or skin cleansers containing are not affected by non-ionic urine components such as chlorhexidine may produce false positive results. False Glucose. If the urine has a pH of 7 or greater, add 0.005 to positive results can also be caused by blood infusion the Specific Gravity reading indicated on the color chart. pH: The pH readings are not affected by variations in urinary • Always hold the strip close to the color chart and Glucose: The reagent area does not react with lactose, galactose, fructose or other metabolic substances, nor • Do not read results after 2 minutes from the specified Leukocytes: The result should be read after 60-120 seconds with reducing metabolites of drugs (e.g. salicylates and to allow for complete color development. The intensity of the nalidixic acid). Effects of Ascorbic Acid on Glucose have been greatly reduced. Glucose concentrations of 100 Do not read results if color changes only appear along color that develops is proportional to the number of mg/dL and above are not effected by Ascorbic Acid Leukocytes present in the urine specimen. High Specific concentrations, and high Ascorbic Acid concentrations The results for Blood include Erythrocytes (ERY) and Gravity or elevated Glucose concentrations (≥ 2000 mg/dL) will unlikely produce false negative results. The Hemoglobin (Hb). Read results according to both may cause test results to be artificially low. The presence of reactivity of the test decreases as the Specific Gravity of cephalexin, cephalothin, or high concentrations of oxalic acid may also cause test results to be artificial y low. Tetracycline S:\pm\allg\inserts\inserts_word\urinestrips\urine strips_z_rev01.doc Produktion und Vertrieb von chemisch - technischen Produkten und Laborinstrumenten Gesellschaft m.b.H. A -2351 Wr. Neudorf – IZ-NÖ Süd – Hondastrasse, Obj. M55 – AUSTRIA Phone ++43 (0) 2236 660910-0 Fax ++43 (0) 2236 660910-30 E-Mail: office@dialab.at Ketone Bodies: The test is more sensitive to acetoacetic REFERENCES
acid than to acetone. Urine specimens of high pigment, 1. Free AH, Free HM. Urinalysis, Critical Discipline of Clinical captopril, mesna, and other substances containing Science. CRC Crit. Rev. Clin. Lab. Sci. 3(4): 481-531, 1972. sulfhydryl groups occasional y react may give false 2. Yoder J, Adams EC, Free, AH. Simultaneous Screening positive results. Phenylketone and phthalein compounds for Urinary Occult Blood, Protein, Glucose, and pH. Amer. J. can produce red coloration on the edges of the reagent area, but are different than the violet colors caused by 3. Henry JB, et al. Clinical Diagnosis and Management by the presence of Ketone bodies and should be Laboratory Methods, 20th Ed. Philadelphia. Saunders.371- Urobilinogen: All results lower than 1 mg/dL 4. Tietz NW. Clinical Guide to Laboratory Tests. W.B. Urobilinogen should be interpreted as normal. A negative result does not at any time preclude the 5. McGarry JD, Lilly. Lecture, 1978: New Perspectives in the absence of Urobilinogen. The reagent area will not react Regulation of Ketogenesis. Diabetes 28: 517-523 May, with interfering substances known to react with Ehrlich’s reagent. False negative results may be obtained if 6. Williamson DH. Physiological Ketoses, or Why Ketone formalin is present. The test cannot be used to detect Bodies? Postgrad. Med. J. (June Suppl.): 372-375, 1971. 7. Paterson P, et al. Maternal and Fetal Ketone Concentrations in Plasma and Urine. Lancet: 862-865; April Bilirubin: Bilirubin is absent in normal urine, so any positive result, including a trace positive, indicates an 8. Fraser J, et al. Studies with a Simplified Nitroprusside underlying pathological condition and requires further Test for Ketone Bodies in Urine, Serum, Plasma and Milk. investigation. Reactions may occur with urine containing large doses of chlorpromazine or rifampen that might be mistaken for positive Bilirubin. The presence of Bilirubin- derived bile pigments may mask the Bilirubin reaction. This phenomenon is characterized by color development on the test patch that does not correlate with the colors on the color chart. Large concentrations of Ascorbic Acid may decrease sensitivity. Blood: A uniform blue color indicates the presence of myoglobin, Hemoglobin or hemolyzed Erythrocytes. Scattered or compacted blue spots indicate intact Erythrocytes. To enhance accuracy, separate color scales are provided for Erythrocytes (ERY) and Hemoglobin (Hb). Positive results with this test are often seen with urine from menstruating females. Microbial peroxidase, associated with urinary tract infection, may cause a false positive reaction. There is little effect caused from Ascorbic Acid. In urine with 5-50 Ery/µL concentrations, hemolysis which may occur on prolonged standing of the urine can cause for higher DIALAB Produktion und Vertrieb von chemisch – technischen concentration values than what are given for intact Produkten und Laborinstrumenten Gesellschaft m.b.H. IZ-NÖ Süd, Hondastrasse, Objekt M55 Phone: ++43 (0) 2236 660910-0 Ascorbic Acid: No interference is known. Fax: ++43 (0) 2236 660910-30 e-mail: office@dialab.at S:\pm\allg\inserts\inserts_word\urinestrips\urine strips_z_rev01.doc

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