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URINE REAGENT STRIPS FOR URINALYSIS--PROTEIN  

SUMMARY
Teco Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed. Depending on the product being used, Teco Urine Reagent Strips provide tests for Glucose, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH and Protein in Urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney function, and acid-base balance.1,2   Please refer to the outside box and bottle label for the specific test parameters of the product you are using.

Teco Urine Reagent Strips are packaged along with a drying agent in a plastic bottle with a twist-off cap. Each strip is stable and ready to use upon removal from the bottle. The entire reagent strip is disposable. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. No calculations or laboratory instruments are required.

TEST PRINCIPLE
This test is based on the protein error-of-indicator principle. At a constant pH, the development of any green color is due to the presence of protein. Colors range from yellow for a "Negative" reaction to yellow-green and green to blue-green for a "Positive" reaction.

REAGENTS (Based on dried weight at time of impregnation)

0.3% w/w tetrabromophenol blue; 99.7% w/w buffer and nonreactive ingredients.

WARNINGS AND PRECAUTIONS
Urine Reagent Strips are for in vitro diagnostic use. Do not touch test areas of Urine Reagent Strips.

STORAGE
Store at room temperature between 15 degrees - 30 degrees C (59 degrees - 86 degrees F) and out of direct sunlight. Do not use after expiration date.

RECOMMENDED HANDLING PROCEDURES
All unused strips must remain in the original bottle. Transfer to any container may cause reagent strips to deteriorate and become nonreactive. Do not remove desiccant from bottle. Do not open container until ready to use. Opened bottles should be used within 3 months after first opening. Work areas and specimen containers should be free of detergent and other contaminating substances.

SPECIMEN COLLECTION AND PREPARATION
Collect urine in a clean container and test as soon as possible. Do not centrifuge. The use of urine preservatives is not recommended. If testing cannot be performed within one hour after voiding, refrigerate the specimen immediately.

Allow refrigerated specimen to return to room temperature before testing.

TEST PROCEDURE

1. Remove from the bottle only enough strips for immediate use and replace cap tightly.
2. Completely immerse reagent areas of the strip in fresh, well-mixed urine. Remove the strip immediately to avoid dissolving out the reagent areas.
3. While removing, touch the side of the strip against the rim of the urine container to remove excess urine. Blot the lengthwise edge of the strip on an absorbent paper towel to further remove excess urine and avoid running over (contamination from adjacent reagent pads.)
4. Compare each reagent area to its corresponding color blocks on the color chart and read at the times specified. Proper read time is critical for optimal results.
5. Obtain results by direct color chart comparison.

Note: All reagent areas may be read between 1-2 minutes for screening positive urine from negative urine. Changes in color after 2 minutes are of no diagnostic value.

QUALITY CONTROL
For best results, performance of reagent strips should be confirmed by testing known negative and positive specimens or controls whenever a new test is performed or whenever a new bottle is first opened. Each laboratory should establish its own goals for adequate standards of performance, and should question handling and testing procedures if these standards are not met.

RESULTS
Results are obtained by direct comparison of the color blocks printed on the bottle label. The color blocks represent nominal values; actual values will vary around the nominal values.

LIMITATIONS OF PROCEDURE
Comparison to the color chart is dependent on the interpretation of the individual. It is therefore recommended that all laboratory personnel interpreting the results of these strips be tested for color blindness.

As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on any single test result or method.

False positive results may be obtained with highly alkaline urine. Contamination of the urine specimen with quarternary ammonium compounds may also produce false positive results.4

EXPECTED VALUES
In 24-hour urine, 1-14 mg/dl of protein may be excreted by the normal kidney.4  A color matching any color block greater than trace indicates significant proteinuria. For urine with 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.

SPECIFIC PERFORMANCE CHARACTERISTICS
The performance characteristics of Teco Urine Reagent Strips (URS) have been determined both in the laboratory and in clinical tests. Parameters of importance to the user are sensitivity, specificity, accuracy, and precision. Generally, Urine Reagent Strips (URS) have been developed to be specific for the constituent to be measured with the exception of interferences listed above. (See LIMITATIONS OF PROCEDURE).

For visually read strips, accuracy is a function of the manner in which the color blocks on the bottle label are determined and the discrimination of the human eye in reading the test. Precision is difficult to assess in a test of this type because of the variability of the human eye. It is for this reason that users are encouraged to develop their own standards of performance.

The test area is more sensitive to albumin than to globulin, hemoglobin, Bence-Jones proteins, and mucoprotein; a negative result does not rule out the presence of these other proteins. The test area is sensitive to 15 mg/dl albumin.  Depending on the inherent variability in clinical urine lesser concentration may be detected under certain conditions.

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