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SCREEN VERIFICATION TEST Urinary tract infections Description In vitro diagnostic medical device CE 0123. Rapid test for the rapid qualitative detection of leukocytes, blood, nitrites and proteins in human urine. For in vitro self-diagnostic use only. Precautions 1. For in vitro self-diagnostic use only. 2. Store in a dry place between 2-30°C (36-86°F), avoiding excessively humid areas. Do not use the product if the sealed package is damaged or opened. 3. Keep out of reach of children. 4. Do not use after the expiration date or if the packaging is damaged. 5. Strictly adhere to the indicated times. 6. Use the test only once. Do not disassemble or touch the test area of the test strip. 7. For external use only. 8. The used test should be disposed of according to local regulations. 9. If you have difficulty identifying color (such as color blindness), ask for help reading the test. How to use It is recommended to collect a urine sample for testing early in the morning as this is the most concentrated. The urine used for testing should not come into contact with toilet water or other disinfectants or cleaning products. For women only: The test should not be performed during or within three days of the menstrual cycle. The urine sample should not be contaminated with vaginal fluids, as this may produce misleading results. Do not make any important medical decisions without first consulting your doctor. COLLECTING URINE: Collect some of the urine in the plastic container provided or use a clean container free of detergent residue. Make sure to fill the container with urine. TEST RUN: 1) Open the sealed package and remove the test strip. Do not touch the test fields. After opening, it is recommended to perform the test immediately. 2) Insert the test strip into the urine sample. CAUTION: Make sure all four test fields are immersed for at least 1-2 seconds. 3) Remove the test strip and remove excess urine by wiping it on the edge of the container or using an absorbent material (e.g. a tissue) to avoid mixing chemicals from nearby areas. Wait 2 minutes (do not read results after 3 minutes). Reading the results Color changes at the edges of the test sticks or after more than 3 minutes should be ignored. NEGATIVE: - the LEUCOCITE test field remained with a tendency towards white; - the BLOOD test field remained yellow-orange; - the test field for NITRITES remained white; - the PROTEIN test field remained yellowish. POSITIVE RESULT FOR LEUKOCYTES: if the area has turned purple, it means that leukocytes are present in the urine. POSITIVE RESULT FOR BLOOD: If the relevant area has turned green (or green dots have appeared at the bottom), it means there is blood in the urine. POSITIVE RESULT FOR NITRITES: If the relevant area has turned pink, it means that nitrites are present in the urine. POSITIVE RESULT FOR PROTEIN: If the relevant area turns green, it means there is protein in the urine. limitation The urinary tract infection (urine) test may be affected by substances that cause abnormal urine color, such as medications containing azo dyes, nitrofurantoin, and riboflavin.1 The color development on the test swab may be masked or the color reaction may be interpreted as a false result. Leukocytes: The result should be read after 2 minutes to allow for complete color development. The intensity of the color that develops is proportional to the number of leukocytes present in the urine specimen. Urine high in protein may reduce the intensity of the color reaction. This test does not react with red blood cells or common bacteria in urine. Blood: A uniform green color indicates the presence of myoglobin, hemoglobin, or hemolyzed red blood cells. 1 Scattered or solid green dots indicate intact red blood cells. To improve accuracy, separate color scales are provided for hemoglobin and red blood cells. Positive test results are often seen in the urine of menstruating women. High urine pH has been reported to reduce sensitivity, while modest to high concentrations of ascorbic acid may inhibit color formation. Microbial peroxidase, associated with urinary tract infections, may cause false positive results. The test is slightly more sensitive to free hemoglobin and myoglobin than to intact red blood cells. Nitrites: The test is specific for nitrites and will not react with any other substance normally excreted in the urine. Any solid pink or red color should be interpreted as a positive result, suggesting the presence of nitrites. The intensity of the color is not proportional to the number of bacteria present in the urine specimen. Pink spots or edges should not be considered a positive result. Comparison of the test with a white background may help identify low levels of nitrites that might otherwise be missed. The sensitivity of this test is reduced for urine specimens with alkaline, highly buffered urine of high specific gravity. A negative result does not in any way exclude the possibility of bacteriuria. Negative results may be obtained in urinary tract infections caused by organisms that do not contain the reductase that converts nitrate to nitrite; nitrate is not converted to nitrite when urine has not been in the bladder long enough (at least 4 hours); when antibiotic therapy is being administered; or when nitrate is absent from the diet. Protein: Any shade of green indicates the presence of protein in the urine. This test is highly sensitive to albumin and less sensitive to hemoglobin, globulins, and mucoproteins. A negative result does not rule out the presence of these or other proteins. False positive results may occur with alkaline or highly buffered urine. Contamination of urine specimens with quaternary ammonium compounds or body soaps containing chlorhexidine may produce false positive results. Urine specimens with high specific gravity may give false negative results. Conservation Store in the package at room temperature (2-30°C). The test is stable until the expiration date printed on the sealed package. The test should remain in the sealed package until use. DO NOT FREEZE. Do not use after the expiration date. Format Package containing 3 pieces. BIBLIOGRAPHY: 1. Henry JB et al. Clinical Diagnosis and Treatment by Laboratory Methods, 20th edition. Philadelphia. Saunders. 371-372, 375, 379, 382, 385, 2001
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