SCREEN
CHECK TEST

Occult Blood
in 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 after the expiration 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 microbiological precautions throughout the test and follow standard procedures for proper specimen disposal.
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 medications taken in excessive doses can cause gastrointestinal irritation resulting in occult bleeding. These substances should be discontinued at least 48 hours before the test.
3. No dietary restrictions are necessary before using the Rapid Test.

How to use
Bring the test, specimen, buffer and/or controls to room temperature (15-30°C) before testing.
1. For fecal sample collection: The fecal sample must be collected using the appropriate collector. Please use the collector in a bathroom to avoid contamination with any chemicals and prevent sample adulteration.
2. To test stool samples: Open the cap of the sample collection tube, then randomly insert the sample collection applicator into the stool sample in at least 3 places. Do not lift the stool sample. Secure the cap onto the sample collection tube, then shake the tube vigorously to mix the sample and extraction buffer. Samples prepared in the collection tube can be stored for up to 6 months at -20°C if not tested within one hour of preparation.
3. Allow the package to reach room temperature before opening. Remove the test tray 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 two 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 the 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: The control line does not appear. The most likely reasons for the control line not appearing are insufficient specimen volume or incorrect procedural techniques. Review the procedure and repeat the test with a new kit. If the problem persists, contact the 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 FOB test (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 pouch. The test must remain in the sealed pouch until use. Do not use beyond the expiration date. Do not freeze.

Format
Pack of 1 piece.