Description
The test for urinary tract infections (urine) consists of rigid plastic strips on which several separate reagent areas are applied.
The test serves for the qualitative detection of the following analytes in urine: blood, proteins, nitrites and leukocytes.
For self-analysis.

How to use
It is recommended to take a urine sample for testing in the early morning as it is the most concentrated. The urine used for the test should not come into contact with toilet water or with any disinfectant or cleaning substance.
Only for women: The test should not be performed during or for three days after the menstrual cycle. The urine sample should not be contaminated with vaginal fluids as this could produce a misleading result.
Do not make important medical decisions without first consulting with your doctor.

Sample collection: Collect part of the urine in the plastic cup provided or using a clean glass without residual detergents. Be sure to fill the glass with urine.

Execution of the test
Open the aluminum bag and pull out the test strip. Do not touch the test fields. Once the envelope is opened, it is recommended to take the test immediately.
Immerse the test strip in the urine sample. Press the strip and make sure that all four fields of the test are immersed for about 1-2 seconds. Then remove the test strip and wipe the excess urine against the edge of the container or with an absorbent material (for example, a paper towel) to avoid mixing chemicals from adjacent reagent areas.
Wait 2 minutes (do not read the results after 3 minutes). Read the result separately for each parameter, compare the color with the color chart provided.

Reading results
Read the result separately for each parameter; compare the color with the color chart provided. Color changes on the edges of the test fields or color changes after more than 3 minutes should be ignored.

NEGATIVE: The field of testing for LEUCOCITES remained whitish.
The field of the test for BLOOD remained mustard yellow.
The testing field for the NITRITES remained white.
The test field for PROTEINS remained yellowish.

POSITIVE FOR LEUCOCITES: If the color of the test field changed to purple, the leukocytes were found in the urine. The presence of leukocytes in the urine is an important symptom of an inflammation of the kidneys and urinary tract. Taking cephalexin and cephalothin or a high concentration of oxalic acid may also cause the test results to be artificially low. Tetracycline can cause reduced reactivity, and high levels of the drug can cause a false negative reaction. A high content of urinary protein can decrease the intensity of the reaction color.

BLOOD POSITIVE: If the color of the test field has turned green (or some green spots appear in the background), blood has been found in the urine. A uniform conversion of the green color indicates the presence of haemoglobin or hemolized erythrocytes; scattered or compact green spots indicate intact erythrocytes. Occult blood in the general urine attributed to the following three reasons, one is a calculation, an inflammation and a cancer. In the aspect of inflammation, such as glomerulonephritis, pyelonephritis, cystitis, but may have hematuria, occult blood will have occurred in the urine. Whether it is kidney stones, ureters or vesicles, they can cause other situations such as occult blood. The tumor can also cause occult blood, such as a benign or malignant tumor of the kidney, ureter and bladder. Menstrual period, constipation can cause a positive result.

POSITIVE FOR NITRATES: If the color of the test field has changed to pink, then nitrites have been found in the urine. Gram-negative bacteria in the urine convert nitrates from food into nitrites. Nitrites react with a chemical in the field of testing and leave a pink tinge. The test result can be distorted if urine does not stay long in the bladder, due to starvation, a plant-free diet or antibiotic treatment. Comparing the test on a white background may aid in the detection of low levels of nitrites, which may otherwise go undetected.

POSITIVE FOR PROTEINS: If the color of the test field turned green, protein was found in the urine. An indicator on the test field reacts with protein in the urine, changing its color to green. They can be found where there is inflammation of the bladder or prostate or bleeding in the urinary tract. Infusions containing polyvinylpyrrolidone can produce a false positive result. Chemical components in the test fields should be considered as potentially hazardous substances, although they do not present a risk, provided that all test components are used in accordance with these instructions.

Warnings
Read the instructions carefully before performing the test.
Only for in vitro diagnostic self-analysis.
Use a clean container not contaminated by cleaning fluids to collect urine.
Keep out of reach of children.
Do not use after the expiration date or if the envelope is damaged.
If the aluminum packaging is damaged or has been opened, do not use it.
Strictly follow the indicated time.
Use the test only once. Do not disassemble and touch the reacting areas of the test strip.
For external use only.
The test used must be disposed of according to local regulations.
In case of difficulty in identifying color (such as color blindness), ask for help in reading the test.
The test can be affected by substances that cause abnormal urine color such as drugs containing azo dyes (e. g. Pyridium, AzoGantrisin, AzoGantanol), nitrofurantoin (Microdantin, Furadantin), and riboflavin. Color development on the test pad may be masked, or a color reaction may be produced that could be interpreted as false results.
Leukocytes: the result should be read at 2 minutes to allow full color development. The intensity of the color that develops is proportional to the number of leukocytes present in the urine sample. High specific gravity or high glucose concentrations (≥ 2,000 mg/dL) may cause artificially low test results. The presence of cephalexin, cephalothin, or high concentrations of oxalic acid may also cause the test results to be artificially low. Tetracycline can cause reduced reactivity, and high levels of the drug can cause a false negative reaction. A high content of urinary protein can decrease the intensity of the reaction color. This test will not react with erythrocytes or common bacteria in the urine.
Blood: a uniform green color indicates the presence of myoglobin, hemoglobin or hemolized erythrocytes. Scattered or compact green spots indicate intact erythrocytes. To improve accuracy, separate color scales are provided for hemoglobin and for erythrocytes. Positive results with this test are often seen with the urine of menstruating females. High pH urine has been reported to reduce sensitivity, while a moderate to high concentration of ascorbic acid can inhibit color formation. Microbial peroxidase, associated with urinary tract infection, can cause a false positive reaction. The test is slightly more sensitive to free hemoglobin and myoglobin than to intact erythrocytes.
Nitrites: The test is specific for nitrites and will not react with any other substance normally excreted in the urine. Any degree of color from pink to uniform red must 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 sample. Pink spots or pink edges should not be interpreted as a positive result. Comparing the area of the reagent reacted against a white background can aid in the detection of low levels of nitrites, which may otherwise be undetected. Ascorbic acid greater than 30 mg/dL can cause false negatives in urine containing less than 0.05 mg/dL nitrite ions. The sensitivity of this test is reduced for urine samples with highly buffered alkaline urine or high specific weight. A negative result never excludes the possibility of bacteruria. Negative results may occur in urinary tract infections from organisms that do not contain reductase to convert nitrate into nitrite; when urine has not been retained in the bladder for a sufficient period of time (at least 4 hours) for the reduction of nitrate to nitrite; When receiving antibiotic therapy or when dietary nitrate is absent.
Protein: any green color indicates the presence of protein in the urine. This test is highly sensitive to albumin and less sensitive to hemoglobin, globulin and mucoprotein. A negative result does not exclude the presence of these other proteins. False positive results can be obtained with highly buffered or alkaline urine. Contamination of urine samples with quaternary ammonium compounds or skin cleansers containing chlorhexidine may produce false positive results. Urine samples with a high specific weight can give false negative results.

storage
Store at room temperature or refrigerated (2-30 °C). Do not freeze.
Validity with intact packaging: 24 months.

Format
The kit contains:
-Test strip;
-Glass for the collection of the sample;
-Color chart;
-Package leaflet.

Bibliography
1. Henry JB, et al. Clinical Diagnosis and Management by Laboratory Methods, 20th Ed. Philadelphia. Saunders. 371-372, 375, 379, 382, 385, 2001. 2. Ma Junlong, Cong Yulong. The effect of bacteriuria on the determination of red blood cells in the urine by the urine analyzer. Chinese Journal of Medical Examination, 1999, 22 (4): 205.
3. Shuai Lihua, Jiujiang Medical Journal 2002, 17 (2): 122.

Cod. SF-017