Descrizione Clinica
Diagnostics - Screen tests infez vie urin 3pz diagnostics
SCREEN
CHECK TEST
Infections of Urinary TractDescription
CE 0123 in vitro diagnostic medical device.
Quick test for fast quality detection of Leukocytes, Blood, Nitritus and Protein in human urine.
Only for auto-diagnostic use in vitro.
Precautions
1. Only for auto-diagnostic use in vitro.
2. Store in a dry place at 2-30°C (36-86°F), avoiding excessively humid areas. If the sealed package is damaged or open, do not use.
3. Keep out of reach of children.
4. Do not use beyond the expiry date or if the packaging is damaged.
5. Strictly follow the times indicated.
6. Use the test only once. Do not disassemble or touch the reactive areas on the test strip.
7. Only for external use.
8. The test used must be disposed of according to local regulations.
9. In case of difficulty in identifying color (as for daltonism), ask for help in reading the test.
Mode of use
It is recommended to take a sample of urine for the test in the early morning since it is the most concentrated. The urine used for the test should not come into contact with the water of the wc or any disinfectant or cleaning product.
Only for women: the test should not be performed during or in the three days following the menstrual cycle. The urine sample should not be contaminated with vaginal fluids as it could produce misleading results.
Do not make important medical decisions without first consulting your doctor.
URINA RACOLATE: collect part of urine in the plastic container provided or use a clean container without detergent residues. Make sure to fill the container with urine.
EXECTION OF TEST:
1) open the sealed package and extract the test strip. Don't touch the test fields. Once the package is opened, it is recommended to run the test immediately;
2) immerse the test strip in the urine sample. WARNING: Make sure all four test fields are immersed for at least 1-2 seconds.
3) remove the test strip and remove the excess urine by passing it on the edge of the container or using absorbent material (e.g. a paper handkerchief) to avoid mixing chemical agents of nearby areas. Wait 2 minutes (do not read the results after 3 minutes).
Reading results
Color variations on the edges of the test pads or over 3 minutes should be ignored.
NEGATIVE:
- the test field for LEUCOCITI has remained white;
- the SANGUE test field remained yellow-orange;
- the NITRITO test field remained white;
- the PROTEINA test field remained yellowish.
POSITIVE RESULT FOR LEUCOCITS: if the color of its area has become lilac, it means that there are leukocytes in urine.
POSITIVE RESULT FOR THE SANGUE: if the color of its area has become green (or green spots on the bottom), it means that there is blood in the urine.
POSITIVE RESULT FOR NITRIATE: if the color of its area has become pink, it means that nitrites are present in urine.
POSITIVE RESULT FOR PROTECTION: if the color of its area has become green, it means that there are proteins in urine.
Limits
The urinary tract infections test (Urine) can be influenced by substances that cause abnormal urine color like drugs containing azoic, nitrofurantoin and riboflavin1 colorants. The color development on the swab of the test can be masked or the colored reaction can be interpreted as a false result.
Leukocytes: the result should be read at 2 minutes to allow a complete color development. The intensity of the color that develops is proportional to the number of leukocytes present in the urine sample. Highly protein urine can lower the intensity of the color reaction. This test does not react with erythrocytes or common bacteria in urine.
Blood: a uniform green color indicates the presence of myoglobin, hemoglobin or erythrocytes1. Spots scattered or compact in green colour indicate intact erythrocytes. To improve accuracy, separate color scales are provided for hemoglobin and erythrocytes. Positive results of the urine test of women are often observed during menstruation. It has been reported that urine with high pH reduces sensitivity, while a concentration from modest to high 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 any other substance normally excreted in urine. Any degree of even pink or red should be interpreted as a positive result, suggesting the presence of nitrite. The color intensity is not proportional to the number of bacteria present in the urine sample. Pink dots or edges should not be considered a positive result. Comparing the test with a white background can help you detect low nitrite levels that may otherwise not be detected. The sensitivity of this test is reduced to urine samples with highly buffered alkaline urine with specific gravity wing. A negative result does not in any way exclude the possibility of bacteriuria. Negative results can be obtained with urinary tract infections by organisms that do not contain reductase that converts nitrate into nitrite; nitrate does not convert to nitrite when urine has not remained sufficiently in the bladder (at least 4 hours); when you are under antibiotic therapy or when nitrate is absent from the diet.
Protein: any green gradation indicates the presence of protein in 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 or other proteins. You can get false positives with alkaline urine or highly buffered. Contamination of urine samples with quaternary ammonium compounds or soaps for the body containing chlorhexidine can produce false positive results. Urine samples with high specific gravity can give false negatives.
Conservation
Store in the packaging at ambient temperatures (2-30°C).
The test is stable until the expiry date printed on the sealed package. The test must remain in the sealed package until the time of use.
DON'T CONGEL.
Do not use beyond the expiry date.
Format
Package containing 3 pieces.
BIBLIOGRAPHY:
1. Henry JB, et al. Clinical Diagnosis and Management by Laboratory Methods, 20th Ed. Philadelphia. Saunders. 371-372, 375, 379, 382, 385, 2001.
CE 0123 in vitro diagnostic medical device.
Quick test for fast quality detection of Leukocytes, Blood, Nitritus and Protein in human urine.
Only for auto-diagnostic use in vitro.
Precautions
1. Only for auto-diagnostic use in vitro.
2. Store in a dry place at 2-30°C (36-86°F), avoiding excessively humid areas. If the sealed package is damaged or open, do not use.
3. Keep out of reach of children.
4. Do not use beyond the expiry date or if the packaging is damaged.
5. Strictly follow the times indicated.
6. Use the test only once. Do not disassemble or touch the reactive areas on the test strip.
7. Only for external use.
8. The test used must be disposed of according to local regulations.
9. In case of difficulty in identifying color (as for daltonism), ask for help in reading the test.
Mode of use
It is recommended to take a sample of urine for the test in the early morning since it is the most concentrated. The urine used for the test should not come into contact with the water of the wc or any disinfectant or cleaning product.
Only for women: the test should not be performed during or in the three days following the menstrual cycle. The urine sample should not be contaminated with vaginal fluids as it could produce misleading results.
Do not make important medical decisions without first consulting your doctor.
URINA RACOLATE: collect part of urine in the plastic container provided or use a clean container without detergent residues. Make sure to fill the container with urine.
EXECTION OF TEST:
1) open the sealed package and extract the test strip. Don't touch the test fields. Once the package is opened, it is recommended to run the test immediately;
2) immerse the test strip in the urine sample. WARNING: Make sure all four test fields are immersed for at least 1-2 seconds.
3) remove the test strip and remove the excess urine by passing it on the edge of the container or using absorbent material (e.g. a paper handkerchief) to avoid mixing chemical agents of nearby areas. Wait 2 minutes (do not read the results after 3 minutes).
Reading results
Color variations on the edges of the test pads or over 3 minutes should be ignored.
NEGATIVE:
- the test field for LEUCOCITI has remained white;
- the SANGUE test field remained yellow-orange;
- the NITRITO test field remained white;
- the PROTEINA test field remained yellowish.
POSITIVE RESULT FOR LEUCOCITS: if the color of its area has become lilac, it means that there are leukocytes in urine.
POSITIVE RESULT FOR THE SANGUE: if the color of its area has become green (or green spots on the bottom), it means that there is blood in the urine.
POSITIVE RESULT FOR NITRIATE: if the color of its area has become pink, it means that nitrites are present in urine.
POSITIVE RESULT FOR PROTECTION: if the color of its area has become green, it means that there are proteins in urine.
Limits
The urinary tract infections test (Urine) can be influenced by substances that cause abnormal urine color like drugs containing azoic, nitrofurantoin and riboflavin1 colorants. The color development on the swab of the test can be masked or the colored reaction can be interpreted as a false result.
Leukocytes: the result should be read at 2 minutes to allow a complete color development. The intensity of the color that develops is proportional to the number of leukocytes present in the urine sample. Highly protein urine can lower the intensity of the color reaction. This test does not react with erythrocytes or common bacteria in urine.
Blood: a uniform green color indicates the presence of myoglobin, hemoglobin or erythrocytes1. Spots scattered or compact in green colour indicate intact erythrocytes. To improve accuracy, separate color scales are provided for hemoglobin and erythrocytes. Positive results of the urine test of women are often observed during menstruation. It has been reported that urine with high pH reduces sensitivity, while a concentration from modest to high 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 any other substance normally excreted in urine. Any degree of even pink or red should be interpreted as a positive result, suggesting the presence of nitrite. The color intensity is not proportional to the number of bacteria present in the urine sample. Pink dots or edges should not be considered a positive result. Comparing the test with a white background can help you detect low nitrite levels that may otherwise not be detected. The sensitivity of this test is reduced to urine samples with highly buffered alkaline urine with specific gravity wing. A negative result does not in any way exclude the possibility of bacteriuria. Negative results can be obtained with urinary tract infections by organisms that do not contain reductase that converts nitrate into nitrite; nitrate does not convert to nitrite when urine has not remained sufficiently in the bladder (at least 4 hours); when you are under antibiotic therapy or when nitrate is absent from the diet.
Protein: any green gradation indicates the presence of protein in 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 or other proteins. You can get false positives with alkaline urine or highly buffered. Contamination of urine samples with quaternary ammonium compounds or soaps for the body containing chlorhexidine can produce false positive results. Urine samples with high specific gravity can give false negatives.
Conservation
Store in the packaging at ambient temperatures (2-30°C).
The test is stable until the expiry date printed on the sealed package. The test must remain in the sealed package until the time of use.
DON'T CONGEL.
Do not use beyond the expiry date.
Format
Package containing 3 pieces.
BIBLIOGRAPHY:
1. Henry JB, et al. Clinical Diagnosis and Management by Laboratory Methods, 20th Ed. Philadelphia. Saunders. 371-372, 375, 379, 382, 385, 2001.
