VET 2K (Canada)

URINE REAGENT STRIPS FOR URINALYSIS

The Package Insert to be used with the following product:

VET 2K

For the semi-quantitative and qualitative detection of Glucose, and Ketone, in urine.

SUMMARY

Teco Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed. 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

Glucose: This test is based on a double sequential enzyme reaction. One enzyme, glucose oxidase, catalyzes the formation of gluconic acid and hydrogen peroxide from the oxidation of glucose. A second enzyme, peroxidase, catalyzes the reaction of hydrogen peroxide with potassium iodide chromogen to oxidize the chromogen to colors ranging from blue-green to greenish-brown through brown and dark brown.

Ketone: This test is based on the reaction of acetoacetic acid with sodium nitroprusside in a strongly basic medium. The colors range from beige or buff-pink color for a “Negative” reading to pink and pink-purple for a “Positive” reading.

REAGENTS (Based on dried weight at time of impregnation)

Glucose: 16.3%w/w glucose oxidase (Aspergillus niger, 1.3IU); 0.6%w/w peroxidase

(horseradish, 3300 IU); 7.0% w/w potassium iodide; 76.1% w/w buffer and non-reactive ingredients.

Ketone: 7.7% w/w sodium nitroprusside balanced with buffer and non-reactive ingredients.

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

Glucose: Moderate amounts of ketone bodies (40mg/dL or greater) may decrease color development in urine containing small amounts of glucose (75-125 mg/dl). However, such concentration of ketone simultaneously with such glucose H concentration is metabolically improbable in screening. The reactivity of the glucose test decreases as the SG and/or ascorbic acid of the urine increases. Reactivity may also vary with temperature.³

Ketone: Color reaction that could be interpreted as “positive” may be obtained with urine specimens containing MESNA or large amounts of phenylketones or L-dopa metabolites.³

EXPECTED VALUES

Glucose: Small amounts of glucose are normally excreted by the kidney. Concentrations as little as 0.1 g/dl glucose, read either at 10 or 30 seconds, may be significantly abnormal if found consistently. At 10 seconds, results should be interpreted qualitatively; for semi-quantitative results, read at 30 seconds only.

Ketone: Normally, no ketones are present in urine. Detectable levels of ketone may occur in urine during physiological stress conditions such as fasting, pregnancy, and frequent strenuous exercise.^6-8 In starvation diets, or in other abnormal carbohydrate metabolism situation, ketones appear in the urine in excessively large amounts before serum ketones are elevated.⁹

BIBLIOGRAPHY

1. Free, A.H. and Free, H.M.: Urinalysis, Critical Discipline of Clinical Science. CRC Crit. Rev. Clin. Lab. Sci. 3(4): 481-531; (1972).

2. Yoder, J. Adams, E.C., and Free. H.M.: Simultaneous Screening for Urinary Occult Blood, Protein, Glucose and pH. Amer. J. Med Tech. 31:285; (1965).

3. Tietz, N.W.: Clinical Guide to Laboratory Tests; W.B. Saunders Company, (1976).

4. Burtis, C.A. and Ashwood, E.R.: Tietz Textbook of Clinical Chemistry 2^nd

5. Schersten, B. and Fritz, H.: Subnormal Levels of Glucose in Urine. JAMA 201:129-132; (1967).

6. McGarry, J.D.: Lilly Lecture, 1978: New Perspectives in the Regulation of Ketogenesis Diabetes 28: 517-523 May, (1978).

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.

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°-30°C(59°-86°F) and out of direct sunlight. Do not use after expiration date.

RECOMMENDED HANDLING PROCEDURES

All unused strips must remain in the original pouch. Transfer to any container may cause reagent strips to deteriorate and become nonreactive. Do not open container until ready to use. Opened pouch should be used within 3 months after first opening.

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 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.

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.

Glucose: This test is specific for glucose; no substances excreted in urine other than glucose is known to give a positive result. The reagent area does not react with lactose, galactose, fructose, or reducing metabolites of drugs; e.g. salicylates and nalidixic acid. This test may be used to determine whether the reducing substances found in urine is glucose. Approximately 100 mg/dl glucose in urine is detectable.

Ketone: The ketone test area provides semi-quantitative results and reacts with acetoacetic acid in urine. This test does not react with beta-hydroxybutyric acid or acetone. The reagent area detects as little as 5-10 mg/dl acetoacetic acid in urine.

Presentation: 10 individual, single test strips per box.

CPN: 2031001.0