Screen Test Blood Feces (Screen Test FOB)

CE in vitro diagnostic medical device 0123.
Rapid, immediate test for the qualitative identification of Occult Human Blood in feces.
For in vitro self-testing 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 package until used.
2. Do not eat, drink, or smoke in the specimen or kit handling area.
3. Handle all specimens as potentially infectious. Observe established precautions against microbiological risk throughout the test and follow standard procedures for proper specimen disposal.
4. Used tests must be disposed of according to local legislation.
5. Humidity and temperature can negatively influence the results.

Sample collection and preparation
1. Specimens should not be collected during or within three days of the menstrual period, or if the patient has 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. The intake of such substances should be stopped at least 48 hours before the test.
3. No food restrictions are necessary before using the Rapid Test.

Mode of use
Bring the test, sample, buffer and/or controls to room temperature (15-30°C) before testing.
1. For the collection of fecal samples: the fecal sample must be collected using the appropriate collector. Please use the stool collector inside a bathroom to avoid contamination with any chemicals and prevent adulteration of the sample.
2. To examine stool specimens: Open the cap of the specimen collection tube, then randomly stick the specimen collection applicator into the stool specimen in at least 3 places. Do not lift the stool sample. Secure the cap on the sample collection tube, then shake the tube vigorously to mix the sample and extraction buffer. Specimens 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. Bring the package to room temperature before opening it. Remove the test holder from the packaging and use it as soon as possible. Better 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) to 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 results after 10 minutes.

Interpretation of results
POSITIVE*: two lines appear. One should always appear in the control line area (C) and another colored line should appear in the test area (T).
NEGATIVE: a colored line appears in the control area (C). No colored lines appear in the test area (T).
NULL: the control line does not appear. The most important reasons Insufficient sample volume or incorrect procedural techniques are likely to cause the control line to fail to appear. Review the procedure and repeat the test with a new kit. If the problem persists, contact the distributor.
*The intensity The color in the test line region (T) varies depending on the concentration of fecal occult blood present in the sample. Therefore any shade of color in the test line area (T) should be considered positive.

Limitations
1. The FOB (Feces) rapid test is an in vitro diagnostic device for individual use.
2. The rapid test for FOB (Stool) 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 must be interpreted in conjunction with other clinical information available to the clinician.
4. In case of equivocal results, other available clinical tests are required.

Storage
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 used. Do not use beyond the expiry date. Do not freeze.

Format
Pack of 1 piece.