URINE REAGENT STRIP Glucose by benbenzhou


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									                                                                                                                        Urine Reagent Strip (2 parameters) Page 1

                                 Atlas Link                                                               URINE REAGENT STRIP
           12720 Dogwood Hills Lane, Fairfax, VA 22033 USA                                                  (2 PARAMETERS)
             Phone: (703) 266-5667, FAX: (703) 266-5664                                                   PROTEIN AND GLUCOSE
          http://www.atlaslink-inc.com, info@atlaslink-inc.com

INTENDED USE:                                                                         bottle. Transfer to any other container may cause reagent strips to
Urine Reagent Strips (URS-2) for Urinalysis are firm plastic strips to                deteriorate and become unreactive.
which are affixed two separate reagent areas. Urine Reagent Strips
provide tests for the semi-quantitative determination of protein and                  Do not remove desiccant(s) from bottle. Replace cap immediately and
glucose in urine.                                                                     tightly after removing reagent strip. Do not touch test areas of the
                                                                                      reagent strip. Work areas and specimen containers should be free of
SUMMARY:                                                                              detergents and other contamination substances. Dip test areas in urine
Test results may provide information regarding the status of                          completely, but briefly, to avoid dissolving out the reagents. Read test
carbohydrate metabolism and kidney function.1-3                                       results carefully at the times specified, in a good light and with the test
                                                                                      area held near the appropriate Color Chart on the bottle label.
The kidney glomeruli act as ultrafilters for the plasma protein;
however as much as 150 mg/dl of protein may normally be excreted                      IMPORTANT: Protection against ambient moisture, light and heat is
into the urine. In glomerular proteinuria, an increase in glomerular                  essential to guard against altered reagent reactivity. Discoloration or
permeability occurs, resulting in an increase of urine proteins. High                 darkening of reagent areas may indicate deterioration. If this is
urine protein concentration therefore may indicate proteinuria.4                      evident, or if test results are questionable or inconsistent with
                                                                                      expected finding, the following steps are recommended: (1) confirm
Blood glucose concentration above the renal threshold will overflow                   that the product is within the expiration date shown on the label. (2)
into the urine. This situation normally arises in diabetes patients. In               check performance against known positive control materials. (3) retest
renal diabetes, the renal threshold is reduced to the point where sugar               with fresh product.
appears in the urine despite normal levels being present in the blood.
In both situations, monitoring of urine glucose becomes important.5                   SPECIMEN COLLECTION AND PREPARATION: Collect
                                                                                      urine in a clean container according to NCCLS GP16-T and test as
CHEMICAL PRINCIPLES OF THE PROCEDURE:                                                 soon as possible. If testing cannot be done within an hour after
Protein: This test is based on the protein error-of-indicators                        voiding, refrigerate the specimen immediately and let it return to room
principle. At a constant pH, the development of any green color is                    temperature before testing.
due to the presence of protein. Colors range from yellow for
"Negative" through yellow-green and green to green-blue for                           Prolonged exposure of unpreserved urine to room temperature may
"Positive" reactions.                                                                 result in microbial proliferation with resultant changes in pH. A shift
                                                                                      to alkaline pH may cause false positive results with the protein test
Glucose: This test is based on a double sequential enzyme reaction.                   area. Urine containing glucose may decrease in pH as organisms
One enzyme, glucose oxidase, catalyzes the formation of gluconic                      metabolize the glucose.
acid and hydrogen peroxide from the oxidation of glucose. A second
enzyme, peroxidase, catalyzes the reaction of hydrogen peroxide with                  Contamination of the urine specimen with skin cleansers containing
a potassium iodide chromogen to oxidize the chromogen to colors                       chlorhexidine may affect protein test results. The user should
ranging from green to brown.                                                          determine whether the use of such skin cleansers is warranted.

REAGENTS: (Based on dry weight at time of impregnation)                               PROCEDURE: MUST BE FOLLOWED EXACTLY TO
Protein: 0.3% w/w tetrabromphenol blue; 99.7% w/w buffer and                          ACHIEVE RELIABLE TEST RESULTS.
     nonreactive ingredients.                                                         1. Collect FRESH urine specimen in a clean dry container. Mix
Glucose: 16.3% w/w glucose oxidase (Aspergillus Niger) (1.3 IU);                         well immediately before testing.
     0.6% w/w peroxidase (Horseradish) (3300 IU); 7.0% w/w                            2. Remove one strip from bottle and close the cap immediately.
     potassium iodide; 60.7% w/w buffer and 15.4%                                        Completely immerse reagent areas of the strip in FRESH urine
     nonreactive ingredients                                                             and remove immediately to avoid dissolving out reagents.
                                                                                      3. While removing, run the edge of the strip against the rim of the
WARNINGS AND PRECAUTIONS: Urine reagent strips are for in                                urine container to remove excess urine. Hold the strip in a
vitro diagnostic use.                                                                    horizontal position to prevent possible mixing of chemicals from
                                                                                         adjacent reagent areas and/or soiling of hands with urine.
STORAGE: Store opened and unopened bottles at temperature                             4. Compare reagent areas to corresponding color chart on the bottle
between 15°- 30°C (59°-86° F) and out of direct sunlight. Do not use                     label at the time specified. HOLD STRIP CLOSE TO COLOR
after expiration date.   Deterioration rate will be affected by                          BLOCKS AND MATCH CAREFULLY.
mishandling of device.
                                                                                      Proper read time is critical for optimal results. The protein parameter
RECOMMENDED PROCEDURES FOR HANDLING URINE                                             may be read at any time up to one minute after dipping. Read the
REAGENT STRIPS: All unused strips must remain in the original                         glucose test at 30 seconds. Both reagent areas may be read between 1
                                                                                      and 2 minutes for screening positive from negative specimens.
                                                   Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
                                                            Phone: (703) 266-5667, FAX: (703) 266-5664
                                                        http://www.atlaslink-inc.com, info@atlaslink-inc.com
                                                                                                                         Urine Reagent Strip (2 parameters) Page 2

QUALITY CONTROL: For best results, performance of reagent                               Glucose: Small amounts of glucose are normally excreted by the
strips should be confirmed by testing known negative and positive                       kidney.8 These amounts are usually below the sensitivity of this test
specimens or control daily or whenever a new bottle is first opened.                    but on occasion may produce a color between the negative and the
Negative and positive specimens or controls may also be randomly                        100 mg/dL color blocks. Results of 100 mg/dL may be significantly
hidden in each batch of specimens tested. Each laboratory should                        abnormal if found consistently.
establish its own goals for adequate standards of performance, and
should question handling and testing procedures if these standards                      PERFORMANCE CHARACTERISTICS:
are not met.                                                                            Sensitivity:
                                                                                        The following table list the generally detectable levels of analytes in
RESULTS: Results with URS-2 are obtained in clinically meaningful                       contrived urine; however, because of the inherent variability of
units directly from the Color Chart comparison. The color blocks                        clinical urines, lesser concentrations may be detected under certain
represent nominal values; actual values will vary around the nominal                    conditions. Sensitivity will vary depending on the limitation factors
values.                                                                                 of each test. (see LIMITATIONS OF PROCEDURE)

LIMITATIONS OF PROCEDURE:                                                               Reagent Area                  Sensitivity
As with all laboratory tests, definitive diagnostic or therapeutic                      Protein                       15 mg/dL albumin
decisions should not be based on any single result or method. These                     Glucose                       100 mg/dL glucose
tests are only for screening; all positive results should be confirmed
by a quantitative method where accuracy and sensitive are greater.                      Specificity
                                                                                        Protein: The reagent area is more sensitive to albumin than to
Substances that cause abnormal urine color, such as Serenium ®*,                        globulins, hemoglobin, Bence-Jones Protein and mucoprotein;
drugs containing azo dyes(e.g.,Pyridium ®**, Azo Gantrisin ®***,                        negative result does not rule out the presence of these other proteins.
Azo Gantanol®***), nitrofurantoin(Macrodantin ®†,Furadantin®†),
and riboflavin, may affect the readability of reagent areas on                          Glucose: The test is specific for glucose; no substance excreted in
urinalysis reagent strips.6 The color development on the reagent pad                    urine other than glucose is known to give a positive result. The
may be masked or a color reaction may be produced on the pad that                       reagent area does not react with lactose, galactose, fructose nor
could be interpreted as a false positive.                                               reducing metabolites of drugs (e.g., salicylates and nalidixic acid).
                                                                                        This test may be used to determine whether the reducing substance
High blood concentration in sample may mask color development or                        found in urine is glucose.
cause atypical color formation. Turbid urine may be used, however
reaction must be observed carefully.                                                    BIBLIOGRAPHY:
                                                                                        1. Free, A.H. and Free, H.M.: Urinalysis, Critical Discipline of
Interpretation of results will depend upon several factors: the                             Clinical Science. CRC Crit. Rev. Clin. Lab. SCI. 3(4): 481-531;
variability of color perception; the presence or absence of inhibitory                      1972
factors; the presence or absence of inhibitory factors typically found                  2. Kark, R.M. et al.: A Primer of Urinalysis, 2nd ed. New York:
in urine, the specific gravity or the pH; and the lighting conditions                       Harper and Row; 1963.
under which the product is used.                                                        3. Yoder, J.,Adams, E.C., and Free, H.M.: Simultaneous screening
                                                                                            for urinary occult blood, protein, glucose and pH. Amer. J. Med
Protein: False positive results may be obtained with highly                                 Tech. 31: 285; 1965.
concentrated or alkaline urine. Contamination of the urine specimen                     4. Burtis C.A. and Ashwood E.R.: Tietz Textbook of Clinical
with quaternary ammonium compounds may also produce false                                   Chemistry 2nd Ed.: 718,1 526; 1994.
positive results.7                                                                      5. Budd M.: Low Blood Sugar (Hypoglycemia) The 20th Century
                                                                                            Epidemic: 55; 1981.
Glucose: Ascorbic acid concentrations of 50 mg/dL or greater may                        6. Tietz, N.W., Fundamentals of Clinical Chemistry 2nd ed. W.B.
cause false negatives for specimens containing small amounts of                             Saunders Company, 1976.
glucose (100 mg/dL). Ketone bodies reduce the sensitivity of the test;                  7. Tietz, N.W., Clinical Guide to Laboratory Tests 2nd ed. W.B.
moderately high ketone levels (40 mg/dL) may cause false negatives                          Saunders Company, 1990.
for specimens containing small amounts of glucose (100 mg/dL) but                       8. Schersten, B. and Fritz, H.: Subnormal levels of Glucose in
the combination of such ketone levels and low glucose levels is                             Urine. JAMA 201: 129-132, 1967.
metabolically improbable in screening. The reactivity of the glucose                    *Serenium® is a registered trademark of E.R. Squibb & Sons.
test increases as the SG of the urine decreases. In dilute urine                        **Pyridum® is a registered trademark of Warner-Chilcott
containing less than 5 mg/dl ascorbic acid, as little as 40 mg/dl                           Laboratories.
glucose may produce a color change that might be interpreted as                         ***Azo Gantrisin® and Azo Gantanol® are registered trade marks of
positive. Reactivity may also vary with temperature.                                        Roche Laboratories, Division of Hoffman-LaRoche, Inc.
                                                                                        †Macrodantin® and Furadantin ® are registered trade marks of
EXPECTED VALUES:                                                                            Norwich-Eaton Pharmaceuticals
Protein: Normal secretion of protein in the urine is less than 15
mg/dl.4 A color matching any block greater than Trace may indicate                      Revised 6/95
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.
                                                     Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
                                                              Phone: (703) 266-5667, FAX: (703) 266-5664
                                                          http://www.atlaslink-inc.com, info@atlaslink-inc.com

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