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					                                                                                                                          Urine Reagent Strip (2 parameters) Page 1



                 Cortez Diagnostics, Inc.                                                                 URINE REAGENT STRIP
                                                                                                            (2 PARAMETERS)
        23961 Craftsman Road, Suite DEF                                                                   PROTEIN AND GLUCOSE
            Calabasas, California 91302
      Tel: (818) 591 3030 / Fax: (818) 591 8383

INTENDED USE:
Urine Reagent Strips (URS-2) for Urinalysis are firm plastic strips to                 Do not remove desiccant(s) from bottle. Replace cap immediately
which are affixed two separate reagent areas. Urine Reagent Strips                     and tightly after removing reagent strip. Do not touch test areas of the
provide tests for the semi-quantitative determination of protein and                   reagent strip. Work areas and specimen containers should be free of
glucose in urine.                                                                      detergents and other contamination substances. Dip test areas in urine
                                                                                       completely, but briefly, to avoid dissolving out the reagents. Read
SUMMARY:                                                                               test results carefully at the times specified, in a good light and with
Test results may provide information regarding the status of                           the test area held near the appropriate Color Chart on the bottle label.
carbohydrate metabolism and kidney function.1-3
                                                                                       IMPORTANT: Protection against ambient moisture, light and heat
The kidney glomeruli act as ultrafilters for the plasma protein;                       is essential to guard against altered reagent reactivity. Discoloration
however as much as 150 mg/dl of protein may normally be excreted                       or darkening of reagent areas may indicate deterioration. If this is
into the urine. In glomerular proteinuria, an increase in glomerular                   evident, or if test results are questionable or inconsistent with
permeability occurs, resulting in an increase of urine proteins. High                  expected finding, the following steps are recommended: (1) confirm
urine protein concentration therefore may indicate proteinuria.4                       that the product is within the expiration date shown on the label. (2)
                                                                                       check performance against known positive control materials. (3)
Blood glucose concentration above the renal threshold will overflow                    retest with fresh product.
into the urine. This situation normally arises in diabetes patients. In
renal diabetes, the renal threshold is reduced to the point where sugar                SPECIMEN COLLECTION AND PREPARATION: Collect
appears in the urine despite normal levels being present in the blood.                 urine in a clean container according to NCCLS GP16-T and test as
In both situations, monitoring of urine glucose becomes important. 5                   soon as possible. If testing cannot be done within an hour after
                                                                                       voiding, refrigerate the specimen immediately and let it return to
CHEMICAL PRINCIPLES OF THE PROCEDURE:                                                  room temperature before testing.
Protein: This test is based on the protein error-of-indicators
principle. At a constant pH, the development of any green color is                     Prolonged exposure of unpreserved urine to room temperature may
due to the presence of protein. Colors range from yellow for                           result in microbial proliferation with resultant changes in pH. A shift
"Negative" through yellow-green and green to green-blue for                            to alkaline pH may cause false positive results with the protein test
"Positive" reactions.                                                                  area. Urine containing glucose may decrease in pH as organisms
                                                                                       metabolize the glucose.
Glucose: This test is based on a double sequential enzyme reaction.
One enzyme, glucose oxidase, catalyzes the formation of gluconic                       Contamination of the urine specimen with skin cleansers containing
acid and hydrogen peroxide from the oxidation of glucose. A second                     chlorhexidine may affect protein test results. The user should
enzyme, peroxidase, catalyzes the reaction of hydrogen peroxide with                   determine whether the use of such skin cleansers is warranted.
a potassium iodide chromogen to oxidize the chromogen to colors
ranging from green to brown.                                                           PROCEDURE: MUST BE FOLLOWED EXACTLY TO
                                                                                       ACHIEVE RELIABLE TEST RESULTS.
REAGENTS: (Based on dry weight at time of impregnation)                                1. Collect FRESH urine specimen in a clean dry container. Mix
Protein: 0.3% w/w tetrabromphenol blue; 99.7% w/w buffer and                              well immediately before testing.
     nonreactive ingredients.                                                          2. Remove one strip from bottle and close the cap immediately.
Glucose: 16.3% w/w glucose oxidase (Aspergillus Niger) (1.3 IU);                          Completely immerse reagent areas of the strip in FRESH urine
     0.6% w/w peroxidase (Horseradish) (3300 IU); 7.0% w/w                                and remove immediately to avoid dissolving out reagents.
     potassium iodide; 60.7% w/w buffer and 15.4%                                      3. While removing, run the edge of the strip against the rim of the
     nonreactive ingredients                                                              urine container to remove excess urine. Hold the strip in a
                                                                                          horizontal position to prevent possible mixing of chemicals from
WARNINGS AND PRECAUTIONS: Urine reagent strips are for                                    adjacent reagent areas and/or soiling of hands with urine.
in vitro diagnostic use.                                                               4. Compare reagent areas to corresponding color chart on the
                                                                                          bottle label at the time specified. HOLD STRIP CLOSE TO
STORAGE: Store opened and unopened bottles at temperature                                 COLOR BLOCKS AND MATCH CAREFULLY.
between 15°- 30°C (59°-86° F) and out of direct sunlight. Do not use
after expiration date. Deterioration rate will be affected by                          Proper read time is critical for optimal results. The protein parameter
mishandling of device.                                                                 may be read at any time up to one minute after dipping. Read the
                                                                                       glucose test at 30 seconds. Both reagent areas may be read between 1
RECOMMENDED PROCEDURES FOR HANDLING URINE                                              and 2 minutes for screening positive from negative specimens.
REAGENT STRIPS: All unused strips must remain in the original
bottle. Transfer to any other container may cause reagent strips to                    QUALITY CONTROL: For best results, performance of reagent
deteriorate and become unreactive.                                                     strips should be confirmed by testing known negative and positive
                                            Diagnostic Automation, Inc.  23961 Craftsman Rd  Calabasas, California 91302
                           Tel: (818) 591-3030 / Fax: (818) 591-8383  E-mail: onestep@rapidtest.com  Website: Http://www.rapidtest.com
                                                                                                                         Urine Reagent Strip (2 parameters) Page 2


specimens or control daily or whenever a new bottle is first opened.                  100 mg/dL color blocks. Results of 100 mg/dL may be significantly
Negative and positive specimens or controls may also be randomly                      abnormal if found consistently.
hidden in each batch of specimens tested. Each laboratory should
establish its own goals for adequate standards of performance, and                    PERFORMANCE CHARACTERISTICS:
should question handling and testing procedures if these standards                    Sensitivity:
are not met.                                                                          The following table list the generally detectable levels of analytes in
                                                                                      contrived urine; however, because of the inherent variability of
RESULTS:        Results with URS-2 are obtained in clinically                         clinical urines, lesser concentrations may be detected under certain
meaningful units directly from the Color Chart comparison. The                        conditions. Sensitivity will vary depending on the limitation factors
color blocks represent nominal values; actual values will vary around                 of each test. (see LIMITATIONS OF PROCEDURE)
the nominal values.
                                                                                      Reagent Area                      Sensitivity
LIMITATIONS OF PROCEDURE:                                                             Protein                           15 mg/dL albumin
As with all laboratory tests, definitive diagnostic or therapeutic                    Glucose                           100 mg/dL glucose
decisions should not be based on any single result or method. These
tests are only for screening; all positive results should be confirmed                Specificity
by a quantitative method where accuracy and sensitive are greater.                    Protein: The reagent area is more sensitive to albumin than to
                                                                                      globulins, hemoglobin, Bence-Jones Protein and mucoprotein;
Substances that cause abnormal urine color, such as Serenium®*,                       negative result does not rule out the presence of these other proteins.
drugs containing azo dyes(e.g.,Pyridium®**, Azo Gantrisin®***,
Azo Gantanol®***), nitrofurantoin(Macrodantin®†,Furadantin®†),                        Glucose: The test is specific for glucose; no substance excreted in
and riboflavin, may affect the readability of reagent areas on                        urine other than glucose is known to give a positive result. The
urinalysis reagent strips.6 The color development on the reagent pad                  reagent area does not react with lactose, galactose, fructose nor
may be masked or a color reaction may be produced on the pad that                     reducing metabolites of drugs (e.g., salicylates and nalidixic acid).
could be interpreted as a false positive.                                             This test may be used to determine whether the reducing substance
                                                                                      found in urine is glucose.
High blood concentration in sample may mask color development or
cause atypical color formation. Turbid urine may be used, however                     BIBLIOGRAPHY:
reaction must be observed carefully.                                                  1. Free, A.H. and Free, H.M.: Urinalysis, Critical Discipline of
                                                                                          Clinical Science. CRC Crit. Rev. Clin. Lab. SCI. 3(4): 481-
Interpretation of results will depend upon several factors: the                           531; 1972
variability of color perception; the presence or absence of inhibitory                2. Kark, R.M. et al.: A Primer of Urinalysis, 2nd ed. New York:
factors; the presence or absence of inhibitory factors typically found                    Harper and Row; 1963.
in urine, the specific gravity or the pH; and the lighting conditions                 3. Yoder, J.,Adams, E.C., and Free, H.M.: Simultaneous screening
under which the product is used.                                                          for urinary occult blood, protein, glucose and pH. Amer. J. Med
                                                                                          Tech. 31: 285; 1965.
Protein: False positive results may be obtained with highly                           4. Burtis C.A. and Ashwood E.R.: Tietz Textbook of Clinical
concentrated or alkaline urine. Contamination of the urine specimen                       Chemistry 2nd Ed.: 718,1 526; 1994.
with quaternary ammonium compounds may also produce false                             5. Budd M.: Low Blood Sugar (Hypoglycemia) The 20th Century
positive results.7                                                                        Epidemic: 55; 1981.
                                                                                      6. Tietz, N.W., Fundamentals of Clinical Chemistry 2nd ed. W.B.
Glucose: Ascorbic acid concentrations of 50 mg/dL or greater may                          Saunders Company, 1976.
cause false negatives for specimens containing small amounts of                       7. Tietz, N.W., Clinical Guide to Laboratory Tests 2nd ed. W.B.
glucose (100 mg/dL). Ketone bodies reduce the sensitivity of the test;                    Saunders Company, 1990.
moderately high ketone levels (40 mg/dL) may cause false negatives                    8. Schersten, B. and Fritz, H.: Subnormal levels of Glucose in
for specimens containing small amounts of glucose (100 mg/dL) but                         Urine. JAMA 201: 129-132, 1967.
the combination of such ketone levels and low glucose levels is                       *Serenium® is a registered trademark of E.R. Squibb & Sons.
metabolically improbable in screening. The reactivity of the glucose                  **Pyridum® is a registered trademark of Warner-Chilcott
test increases as the SG of the urine decreases. In dilute urine                          Laboratories.
containing less than 5 mg/dl ascorbic acid, as little as 40 mg/dl                     ***Azo Gantrisin® and Azo Gantanol® are registered trade marks of
glucose may produce a color change that might be interpreted as                           Roche Laboratories, Division of Hoffman-LaRoche, Inc.
positive. Reactivity may also vary with temperature.                                  †Macrodantin® and Furadantin® are registered trade marks of
                                                                                          Norwich-Eaton Pharmaceuticals
EXPECTED VALUES:
Protein: Normal secretion of protein in the urine is less than 15                     Revised 6/95
mg/dl.4 A color matching any block greater than Trace may indicate
significant proteinuria. For urine of high specific gravity, the test
area may most closely match the trace color block even though only
normal concentrations of protein are present. Clinical judgment is
needed to evaluate the significance of trace results.

Glucose: Small amounts of glucose are normally excreted by the
kidney.8 These amounts are usually below the sensitivity of this test
but on occasion may produce a color between the negative and the
                                           Diagnostic Automation, Inc.  23961 Craftsman Rd  Calabasas, California 91302
                          Tel: (818) 591-3030 / Fax: (818) 591-8383  E-mail: onestep@rapidtest.com  Website: Http://www.rapidtest.com

				
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