Descrizione Clinica
Diagnostics - diagnostics Screen blood test stool 1pz
SCREEN
CHECK TEST
Occult Bloodin the feces
FOBUS
Description
CE 0123 in vitro diagnostic medical device.
Quick test, immediate for qualitative identification of Occult Human Blood in feces.
Exclusively for self-diagnostic use in vitro.
Precautions
In vitro diagnostic device for individual use. Do not use beyond the expiry date.
1. The test must remain in the sealed package until use.
2. Do not eat, drink or smoke in the sample handling area or kits.
3. Manipulate all samples as potentially infectious. Observe the precautions established against microbiological risk throughout the duration of the test and follow standard procedures for correct disposal of samples.
4. The tests used must be disposed of according to local legislation.
5. Humidity and temperature can negatively affect the results.
Sample collection and preparation
1. Samples should not be collected during or within three days of the menstrual period, or if the patient suffers from bleeding hemorrhoids or blood in the urine.
2. Alcohol, aspirin and other drugs taken in excessive doses can cause gastrointestinal irritation resulting in occult bleeding. Intake of such substances should be interrupted at least 48 hours before testing.
3. No food restrictions are needed before using the Rapid Test.
Mode of use
Bring the test, sample, buffer and/or ambient temperature controls (15-30°C) before testing.
1. For fecal samples collection: the fecal sample must be collected through the appropriate collector. Please use the pick-fly inside a bathroom to avoid contamination with any chemical agent and prevent adulteration of the sample.
2. To examine the fecal samples: open the sample collection test cap, then randomly infiltrate the sample harvester applicator in the fecal sample at at least 3 points. Don't lift the fecal sample. Ensure the cap on the sample collection test, then shake the tube vigorously to mix the sample and extraction buffer. Samples prepared in the collection test can be stored up to 6 months at -20°C if they are not tested within an hour of preparation.
3. Bring the packaging to room temperature before opening it. Remove the test support from the package and use it as soon as possible. You will get better results if the test is executed immediately after opening the package.
4. Keep the sample collection test straight and open the cap. Rotate the test tube and transfer 2 full drops of the sample extracted (about 80 microliters) into the sample well (S) of the support, then start the timer. Avoid trapped air bubbles in the sample cockpit (S).
5. Read the results after 5 minutes. Do not read the results spent 10 minutes.
Interpretation of results
POSITIVE*: two lines appear. One must always appear in the control line zone (C) and another colored line must appear in the test zone (T).
NEGATIVO: a coloured line appears in the control area (C). No coloured line appears in the test zone (T).
NULLO: no control line appears. The most probable reasons for the failure of the control line are an insufficient sample volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists contact the distributor.
*The color intensity in the area of the test line (T) varies depending on the concentration of fecal occult blood present in the sample. Therefore, each color shade in the test line area (T) should be considered positive.
Limitation
1. The FOB (Feci) rapid test is an in vitro diagnostic device for individual use.
2. The rapid test for FOB (Feci) indicates only the presence of Fecal Occult Blood, the presence of blood in the feces does not necessarily indicate colorectal bleeding.
3. As with all quick tests, all results must be interpreted together with other clinical information available to the doctor.
4. In case of doubtful results, other clinical trials are required.
Conservation
The kit can be stored at room temperature (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. Do not use beyond the expiry date. Don't freeze.
Format
Pack of 1 piece.
CE 0123 in vitro diagnostic medical device.
Quick test, immediate for qualitative identification of Occult Human Blood in feces.
Exclusively for self-diagnostic use in vitro.
Precautions
In vitro diagnostic device for individual use. Do not use beyond the expiry date.
1. The test must remain in the sealed package until use.
2. Do not eat, drink or smoke in the sample handling area or kits.
3. Manipulate all samples as potentially infectious. Observe the precautions established against microbiological risk throughout the duration of the test and follow standard procedures for correct disposal of samples.
4. The tests used must be disposed of according to local legislation.
5. Humidity and temperature can negatively affect the results.
Sample collection and preparation
1. Samples should not be collected during or within three days of the menstrual period, or if the patient suffers from bleeding hemorrhoids or blood in the urine.
2. Alcohol, aspirin and other drugs taken in excessive doses can cause gastrointestinal irritation resulting in occult bleeding. Intake of such substances should be interrupted at least 48 hours before testing.
3. No food restrictions are needed before using the Rapid Test.
Mode of use
Bring the test, sample, buffer and/or ambient temperature controls (15-30°C) before testing.
1. For fecal samples collection: the fecal sample must be collected through the appropriate collector. Please use the pick-fly inside a bathroom to avoid contamination with any chemical agent and prevent adulteration of the sample.
2. To examine the fecal samples: open the sample collection test cap, then randomly infiltrate the sample harvester applicator in the fecal sample at at least 3 points. Don't lift the fecal sample. Ensure the cap on the sample collection test, then shake the tube vigorously to mix the sample and extraction buffer. Samples prepared in the collection test can be stored up to 6 months at -20°C if they are not tested within an hour of preparation.
3. Bring the packaging to room temperature before opening it. Remove the test support from the package and use it as soon as possible. You will get better results if the test is executed immediately after opening the package.
4. Keep the sample collection test straight and open the cap. Rotate the test tube and transfer 2 full drops of the sample extracted (about 80 microliters) into the sample well (S) of the support, then start the timer. Avoid trapped air bubbles in the sample cockpit (S).
5. Read the results after 5 minutes. Do not read the results spent 10 minutes.
Interpretation of results
POSITIVE*: two lines appear. One must always appear in the control line zone (C) and another colored line must appear in the test zone (T).
NEGATIVO: a coloured line appears in the control area (C). No coloured line appears in the test zone (T).
NULLO: no control line appears. The most probable reasons for the failure of the control line are an insufficient sample volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists contact the distributor.
*The color intensity in the area of the test line (T) varies depending on the concentration of fecal occult blood present in the sample. Therefore, each color shade in the test line area (T) should be considered positive.
Limitation
1. The FOB (Feci) rapid test is an in vitro diagnostic device for individual use.
2. The rapid test for FOB (Feci) indicates only the presence of Fecal Occult Blood, the presence of blood in the feces does not necessarily indicate colorectal bleeding.
3. As with all quick tests, all results must be interpreted together with other clinical information available to the doctor.
4. In case of doubtful results, other clinical trials are required.
Conservation
The kit can be stored at room temperature (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. Do not use beyond the expiry date. Don't freeze.
Format
Pack of 1 piece.
