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SoFarma URINARY INFECTION TEST Description The urinary tract infection (urine) test consists of hard plastic strips, on which several separate areas of reagents are applied. The test is used for the qualitative detection of the following substances in urine: blood, protein, nitrite and leukocytes. For self-analysis. 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 agents. For women only: The test should not be performed during or for three days after your menstrual cycle. The urine sample should not be contaminated with vaginal fluids, as this may produce a misleading result. Do not make any important medical decisions without first consulting your doctor. Collecting the sample : Collect some of the urine in the plastic cup provided or using a clean, detergent-free cup. Make sure to fill the cup with urine. Running the test Open the foil pouch and remove the test strip. Do not touch the test fields. After opening the pouch, it is recommended to perform the test immediately. Insert the test strip into the urine sample. Press the strip down and make sure all four test fields are submerged for approximately 1-2 seconds. Then remove the test strip and wipe away any excess urine on the edge of the container or with an absorbent material (such as a paper towel) to avoid mixing chemicals from adjacent reagent fields. Wait 2 minutes (do not read results after 3 minutes). Read results separately for each parameter and compare color to color chart provided. Reading the results Read the result separately for each parameter; compare the color with the color chart provided. Color changes at the edges of the test fields or color changes after more than 3 minutes should be ignored. NEGATIVE: LEUCOCYTE test field remained whitish. The BLOOD test field remained mustard yellow. The test field for NITRITES remained empty. The PROTEIN test field remained yellowish. POSITIVE FOR LEUKOCYTES: If the color of the test field has changed to purple, it means that leukocytes have been detected in the urine. The presence of leukocytes in the urine is an important symptom of inflammation of the kidneys and urinary tract. The administration of cephalexin and cephalothin or a high concentration of oxalic acid can also lead to artificially low test results. Tetracycline may cause reduced reactivity, and high levels of the drug may cause a false negative reaction. High protein content in the urine may reduce the intensity of the color reaction. POSITIVE FOR BLOOD: If the test field turns green (or a few green spots appear on the background), blood has been detected in the urine. A uniform green color change indicates the presence of hemoglobin or hemolyzed red blood cells; scattered or solid green spots indicate intact red blood cells. Occult blood in the urine is generally attributed to the following three causes: Kidney, ureter, or bladder stones can also cause other conditions such as occult blood. Cancer can also cause occult blood, as can benign or malignant tumors of the kidney, ureter, and bladder. Menstrual periods and constipation can also cause a positive result. POSITIVE FOR NITRITES: If the color of the test field changes to pink, nitrites have been found in the urine. Gram-negative bacteria in the urine convert nitrates from food to nitrites. Nitrites react with a chemical in the test field, leaving a pink tint. The test result may be distorted if urine does not remain in the bladder for a long period of time, due to starvation, a plant-free diet, or antibiotic treatment. Comparing the test to a white background can help detect low levels of nitrites that might otherwise be missed. PROTEIN POSITIVE: If the test field turns green, protein has been detected in the urine. An indicator on the test field reacts with the protein in the urine, changing its color to green. Proteins can be found where there is inflammation of the bladder or prostate or bleeding in the urinary tract. Infusions containing polyvinylpyrrolidone may produce a false positive result. The chemical components in the test fields should be considered potentially hazardous substances, although they do not pose a risk, provided that all test components are used according to these instructions. warnings Read the instructions carefully before performing the test. For in vitro diagnostic self-testing only. Use a clean container, uncontaminated with cleaning fluids, to collect urine. Keep out of reach of children. Do not use after the expiration date or if the sachet is damaged. If the foil packaging is damaged or has been opened, do not use it. Strictly adhere to the indicated time. Use the test only once. Do not disassemble or touch the reagent areas of the test strip. For external use only. The used test should be disposed of according to local regulations. If you have difficulty identifying colors (such as color blindness), ask for help reading the test. The test may be affected by substances that cause abnormal urine color, such as medications containing azo dyes (e.g., Pyridium, AzoGantrisin, AzoGantanol), nitrofurantoin (Microdantin, Furadantin), and riboflavin. The color development on the test swab may be masked or a color reaction may occur, which could be interpreted as false results. 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. High specific gravity or high glucose concentrations (≥2,000 mg/dl) may lead to artificially low test results. The presence of cephalexin, cephalothin, or high concentrations of oxalic acid may also lead to artificially low test results. Tetracycline may cause reduced reactivity, and high drug levels may cause a false negative reaction. High urinary protein content may reduce the intensity of the color reaction. This test will 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. Scattered or solid green spots indicate intact red blood cells. To improve accuracy, separate color scales are provided for hemoglobin and red blood cells. Positive results with this test are often seen in the urine of menstruating women. High urine pH has been reported to reduce sensitivity, while moderate to high concentrations of ascorbic acid may inhibit color formation. Microbial peroxidase, associated with urinary tract infections, may cause a false positive reaction. 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 to 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 pink edges should not be interpreted as a positive result. Comparison of the surface of the reacted reagent with a white background may aid in the detection of low levels of nitrites that may otherwise be missed. Ascorbic acid greater than 30 mg/dl may cause false negative results in urine containing less than 0.05 mg/dl of nitrite ions. The sensitivity of this test is reduced for urine specimens containing highly buffered alkaline urine or a high specific gravity. A negative result never excludes the possibility of bacteriuria. Negative results may occur in urinary tract infections caused by organisms that do not contain the reductase to convert nitrate to nitrite; when urine has not been retained in the bladder for a sufficient period of time (at least 4 hours) for nitrate to be reduced to nitrite; when antibiotic therapy is administered or when dietary nitrate is absent. Protein: Any green color indicates the presence of protein in the urine. This test is very sensitive to albumin and less sensitive to hemoglobin, globulins, and mucoproteins. A negative result does not exclude the presence of these other proteins. False positive results may occur with highly buffered or alkaline urine. Contamination of urine specimens with quaternary ammonium compounds or skin cleansers containing chlorhexidine may produce false positive results. Urine specimens with a high specific gravity may produce false negative results. Conservation Store at room temperature or in a refrigerator (2-30°C). Do not freeze. Shelf life in intact packaging: 24 months. Format The kit contains: - test strip; - glass for collecting samples; - color chart; - the prospectus. Bibliography 1. Henry JB et al. Clinical Diagnosis and Management by Laboratory Methods, 20th Edition. Philadelphia. Saunders. 371-372, 375, 379, 382, 385, 2001. 2. Ma Junlong, Cong Yulong. Effect of bacteriuria on determination of urine red blood cell count by urine analyzer. Chinese Journal of Medical Examination, 1999, 22 (4): 205. 3. Shuai Lihua, Jiujiang Medical Journal 2002, 17 (2): 122. Code SF-017
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