WHY DO I NEED TO TEST FOR KETONE?
Ketone is a substance that can be found in trace amounts in urine. However, when large amounts of ketone are found in your urine it is an indication of a serious problem, especially for people with diabetes.
Ketone is produced when you burn too much fat and carbohydrates. This situation is more likely to be found in people with Type I Diabetes (insulin dependent). When you produce a lot of ketones, it is a good indication that your diabetes may be out of control. This complication is called Ketoacidosis and can lead to a coma. The Urine Test for Ketone can provide a warning signal for you to contact a doctor or health care provider before your diabetes gets out of control. Your doctor or health care provider can then recommend the necessary actions for you to get better.
DEVICE DESCRIPTION:
URS-1K strips for Urinalysis are firm plastic strips to which a ketone reagent area is affixed. URS-1K strips are packaged along with a drying agent in a plastic bottle with a twist off cap. Each strip is 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.
MATERIALS PROVIDED:
1. One bottle containing 100 strips of URS-1K.
2. A visual comparison color chart for reading test results is printed on the bottle label.
WARNINGS AND PRECAUTIONS:
1. Any visual impairment, such as color blindness, will affect accuracy of reading the results.
2. To obtain best results, use fresh urine.
3. Follow directions exactly.
4. For optimal results, accurate timing is essential.
5. Exposure of URS-1K to light, moisture, or heat will cause deterioration and decrease reactivity.
6. The user should follow up all positive results with his or her health care provider.
7. Do not use after expiration date.
STORAGE AND HANDLING:
NOTE: All warnings, precautions, and proper storage procedures must be followed to avoid deterioration and insure reactivity of URS-1K.
1. Store bottle at temperatures between 15°- 30°C (59°- 86° F) and out of direct sunlight.
2. Do not use after expiration date.
3. Throw the old bottle away and use a new bottle of URS-1K after 6 months has passed from breaking the safety seal.
4. All unused strips must remain in original bottle. Transfer to any other container may cause reagent strips to deteriorate and become nonreactive.
5. Do not remove the white packet (desiccants) from bottle. Replace cap immediately and tightly after removing reagent strip.
6. Do not touch test areas of the reagent strip.
SETUP INSTRUCTIONS:
Work areas and specimen containers should be free of contaminating substances. Collect urine in a clean container and test as soon as possible. If testing cannot be performed within one hour, refrigerate the specimen immediately. Allow refrigerated specimen to return to room temperature before testing.
READING THE RESULTS:
When a strip is dipped in urine, the test pad changes color according to the amount of ketone present in the urine. The developing color of the test pad is compared to the color chart found on the bottle after 40 seconds. Each color block corresponds to a number, which indicates the qualitative amount of ketone present in the urine sample. The colors range from beige for a “Negative” reading, to pink and purple for “Positive” readings.
EXPECTED VALUES:
Normally no ketones are present in urine. Detectable levels of ketone occur in urine during physiological stress conditions such as fasting, pregnancy, and frequent strenuous exercise. In starvation diets or in other abnormal carbohydrate metabolism situation, ketone appears in the urine in excessively large amounts before serum ketones are elevated.
PROCEDURE: (MUST BE FOLLOWED EXACTLY TO ACHIEVE RELIABLE TEST RESULTS.)
Note: A positive result from a screening is considered to be a preliminary or indefinite result and should never be interpreted as final without a follow-up with a Health Care provider and confirmation testing.
1. Collect urine specimen in a clean, dry container.
2. Open bottle and remove one test strip. Immediately replace cap on bottle. Hold the plastic end of the strip. Do NOT touch the test area of the strip.
3. Dip the test pad of the strip in the urine sample and remove immediately.
4. Remove excess urine on the strip by drawing edge of strip against the rim of the urine container.
5. Begin timing for 40 seconds.
6. Compare the test pad to the color chart found on the bottle label at exactly 40 seconds.
7. All positive results should be reconfirmed by a Health Care Provider.
