Description
SCREEN
CHECK TEST
Occult Bloodin the feces
FOB
Description
In vitro diagnostic medical device CE 0123.
Rapid, immediate test for the qualitative detection of Human Occult Blood in stool.
For in vitro self-diagnostic use only.
Precautions
In vitro diagnostic device for individual use. Do not use beyond the expiry date.
1. The test must remain in the sealed pouch until use.
2. Do not eat, drink or smoke in the specimen or kit handling area.
3. Handle all specimens as if potentially infectious. Observe established precautions against microbiological risk throughout the test and follow standard procedures for proper disposal of specimens.
4. Used tests must be disposed of in accordance with local regulations.
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 a 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. These substances should be stopped at least 48 hours before the test.
3. No dietary restrictions are required before using the Rapid Test.
How to use
Bring the test, specimen, buffer and/or controls to room temperature (15-30°C) before performing the test.
1. For fecal sample collection: The fecal sample should be collected using the fecal sample collector. Please use the fecal sample collector inside a bathroom to avoid contamination with any chemical agent and prevent adulteration of the sample.
2. To test stool specimens: Open the cap of the specimen collection tube, then randomly insert the specimen collection applicator into the stool specimen in at least 3 places. Do not lift the stool specimen. Secure the cap onto the specimen collection tube, then shake the tube vigorously to mix the specimen and extraction buffer. Specimens prepared in the collection tube may be stored for up to 6 months at -20°C if not tested within 1 hour of preparation.
3. Allow the package to reach room temperature before opening. Remove the test holder from the package and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the package.
4. Hold the sample collection tube upright and open the cap. Invert the tube and transfer 2 full drops of the extracted sample (approximately 80 microliters) into the sample well (S) of the holder, then start the timer. Avoid trapping air bubbles in the sample well (S).
5. Read the results after 5 minutes. Do not read the results after 10 minutes.
Interpretation of results
POSITIVE*: Two lines appear. One must always appear in the control line region (C) and another colored line must appear in the test line region (T).
NEGATIVE: A colored line appears in the control region (C). No colored line appears in the test region (T).
NULL: No control line appears. The most likely reasons for the failure of the control line to appear are insufficient specimen volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, contact your distributor.
*The intensity of the color in the test line region (T) varies depending on the concentration of fecal occult blood in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
Limitations
1. The FOB Rapid Test (Feces) is an in vitro diagnostic device for individual use.
2. The Rapid Test for FOB (Feces) only indicates the presence of Fecal Occult Blood, the presence of blood in the stool does not necessarily indicate colorectal bleeding.
3. As with all rapid tests, all results should be interpreted in conjunction with other clinical information available to the physician.
4. In case of doubtful results, other available clinical tests are required.
Conservation
The kit can be stored at room temperature (2-30°C). The test is stable until the expiration date printed on the sealed package. The test must remain in the sealed package until use. Do not use beyond the expiration date. Do not freeze.
Format
Pack of 1 piece.
In vitro diagnostic medical device CE 0123.
Rapid, immediate test for the qualitative detection of Human Occult Blood in stool.
For in vitro self-diagnostic use only.
Precautions
In vitro diagnostic device for individual use. Do not use beyond the expiry date.
1. The test must remain in the sealed pouch until use.
2. Do not eat, drink or smoke in the specimen or kit handling area.
3. Handle all specimens as if potentially infectious. Observe established precautions against microbiological risk throughout the test and follow standard procedures for proper disposal of specimens.
4. Used tests must be disposed of in accordance with local regulations.
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 a 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. These substances should be stopped at least 48 hours before the test.
3. No dietary restrictions are required before using the Rapid Test.
How to use
Bring the test, specimen, buffer and/or controls to room temperature (15-30°C) before performing the test.
1. For fecal sample collection: The fecal sample should be collected using the fecal sample collector. Please use the fecal sample collector inside a bathroom to avoid contamination with any chemical agent and prevent adulteration of the sample.
2. To test stool specimens: Open the cap of the specimen collection tube, then randomly insert the specimen collection applicator into the stool specimen in at least 3 places. Do not lift the stool specimen. Secure the cap onto the specimen collection tube, then shake the tube vigorously to mix the specimen and extraction buffer. Specimens prepared in the collection tube may be stored for up to 6 months at -20°C if not tested within 1 hour of preparation.
3. Allow the package to reach room temperature before opening. Remove the test holder from the package and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the package.
4. Hold the sample collection tube upright and open the cap. Invert the tube and transfer 2 full drops of the extracted sample (approximately 80 microliters) into the sample well (S) of the holder, then start the timer. Avoid trapping air bubbles in the sample well (S).
5. Read the results after 5 minutes. Do not read the results after 10 minutes.
Interpretation of results
POSITIVE*: Two lines appear. One must always appear in the control line region (C) and another colored line must appear in the test line region (T).
NEGATIVE: A colored line appears in the control region (C). No colored line appears in the test region (T).
NULL: No control line appears. The most likely reasons for the failure of the control line to appear are insufficient specimen volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, contact your distributor.
*The intensity of the color in the test line region (T) varies depending on the concentration of fecal occult blood in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
Limitations
1. The FOB Rapid Test (Feces) is an in vitro diagnostic device for individual use.
2. The Rapid Test for FOB (Feces) only indicates the presence of Fecal Occult Blood, the presence of blood in the stool does not necessarily indicate colorectal bleeding.
3. As with all rapid tests, all results should be interpreted in conjunction with other clinical information available to the physician.
4. In case of doubtful results, other available clinical tests are required.
Conservation
The kit can be stored at room temperature (2-30°C). The test is stable until the expiration date printed on the sealed package. The test must remain in the sealed package until use. Do not use beyond the expiration date. Do not freeze.
Format
Pack of 1 piece.
