Screen Check Test Urinary Tract Infections

In vitro diagnostic medical device CE 0123.
Rapid test for the rapid qualitative detection of Leukocytes, Blood, Nitrite and Protein 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 at 2-30 ° C (36-86 ° F), avoiding excessively humid areas. If the sealed package is; damaged or opened, do not use.
3. Keep out of reach of children.
4. Do not use beyond the expiration date or if package is damaged.
5. Follow the indicated times strictly.
6. Use the test only once. Do not disassemble n é touch the test areas on the test strip.
7. For external use only.
8. Used test should be disposed of according to local regulations.
9. In case of difficulty; in identifying color (as for color blindness), ask for help reading the test.

Modality; of use
It is recommended to take a urine sample for testing early in the morning as é And; the most; concentrated. The urine used for the test should not come in contact with toilet water or any disinfectant or cleaning product.
For women only: The test should not be performed during or for three days following your period. The urine sample should not be contaminated with vaginal fluids since é may produce misleading results.
Do not make important medical decisions without first consulting your doctor. URINE COLLECTION: Collect some urine in the plastic container provided or use a clean container with no detergent residue. Be sure to fill the container with urine.
RUNNING THE TEST:
1) Open the sealed pouch and take out the test strip. Do not touch the test fields. Once the package has been opened it is recommended to perform the test immediately;
2) Immerse the test strip in the urine sample. CAUTION: Make sure all four test fields are submerged for at least 1-2 seconds.
3) Remove the test strip and remove excess urine by swiping it over the rim of the container or using absorbent material (e.g. a paper handkerchief) to avoid mixing chemicals from nearby areas. Wait 2 minutes (do not read results after 3 minutes).

Reading results
Color changes on the edges of the test pads or beyond 3 minutes should be ignored .
NEGATIVE:
- the LEUCOCYTES test field is; remained tending to white;
- the field of the test relating to BLOOD is; remained yellow-orange;
- the test field relating to NITRITE is; remained white;
- the test field relating to PROTEIN is; remained yellowish.
POSITIVE RESULT FOR LEUCOCYTES: if the color of the relative area is; turned lilac, it means that there are leukocytes in the urine.
POSITIVE RESULT FOR THE BLOOD: if the color of the relative area is; turned green (or green dots have appeared on the bottom), it means that it is; present of blood in the urine.
POSITIVE RESULT FOR NITRITE: if the color of the relative area is; turned pink, it means that nitrites are present in the urine.
POSITIVE RESULT FOR PROTEIN: if the color of the relative area is; turned green, it means that there is protein in the urine.

Limitations
Testing for urinary tract infections (Urine) can; be affected by substances that cause abnormal urine color such as drugs containing azo dyes, nitrofurantoin and riboflavin1. Color development on the test swab can; be masked or colored reaction can; be interpreted as a false result.
Leukocytes: The result should be read at 2 minutes to allow for complete color development. The intensity; of the color that develops é; proportional to the number of leukocytes present in the urine sample. A high protein urine can; lower the intensity; of the color reaction. This test does not react with common erythrocytes or bacteria in urine.
Blood: A solid green color indicates the presence of myoglobin, hemoglobin, or hemolyzed erythrocytes1. Scattered or compact green dots indicate intact erythrocytes. To improve accuracy, separate color scales are provided for hemoglobin and erythrocytes. Positive urine test results of women are often observed during menstruation. And; Urine with high pH has been reported to reduce sensitivity; while a low to high concentration of ascorbic acid can; inhibit color formation. Microbial peroxidase associated with urinary tract infections can; cause false positives. The test is; slightly more; sensitive to free hemoglobin and myoglobin than to intact erythrocytes.
Nitrite: the test is; specific for nitrite and will not react; with no other substance normally excreted in the urine. Any degree of uniform pink or red should be interpreted as a positive result, suggesting the presence of nitrite. The intensity; of color is not; proportional to the number of bacteria present in the urine sample. Pink dots or edges should not be considered a positive result. Compare the test with a white background can; help detect low nitrite levels that may otherwise go undetected. The sensibility; of this test is; reduced for urine specimens with highly buffered alkaline urine with severity wing; specific. A negative result in no way excludes the possibility; of bacteriuria. Negative results can be obtained with urinary tract infections by organisms that do not contain reductase which converts nitrate to nitrite; nitrate does not convert to nitrite when urine is not; remained sufficiently in the bladder (at least 4 hours); when you are; under antibiotic therapy or when the 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, globulin and mucoprotein. A negative result does not rule out the presence of these or other proteins. False positives can be obtained with alkaline or highly buffered urine. Contamination of urine samples with quaternary ammonium compounds or body soaps containing chlorhexidine can; produce false positive results. Urine samples with high severity; specification can give false negatives.

Storage
Store in the package at room temperatures (2-30 ° C).
The test is; stable until the expiration date printed on the sealed package. The test must remain in the sealed pouch until use.
DO NOT FREEZE.
Do not use beyond the expiration date.

Format
Pack containing 3 pieces.