Blood Feces Test Screen

Description
In vitro diagnostic medical device CE 0123.
Rapid, immediate test for qualitative detection of Human Hidden Blood in stool.
For in vitro self-diagnosis use only.

Precautions
In vitro diagnostic device for individual use. Do not use beyond the expiration date.
1. The test must remain in the sealed package until use.
2. Do not eat, drink, or smoke in the sample or kit handling area.
3. Handle all samples as potentially infectious. Follow microbiological safety precautions throughout the test and follow standard procedures for proper sample disposal.
4. Used tests must be disposed of according to local regulations.
5. Humidity and temperature can negatively affect results.

Sample collection and preparation
1. Samples should not be collected during or within three days of menstruation or if the patient suffers from bleeding hemorrhoids or blood in the urine.
2. Alcohol, aspirin, and other medications taken in excess can cause gastrointestinal irritation resulting in hidden bleeding. The intake of such substances should be stopped at least 48 hours before the test.
3. No dietary restrictions are necessary before using the Rapid Test.

Method of use
Bring the test, sample, buffer, and/or controls to room temperature (15-30°C) before performing the test.
1. For stool sample collection: the stool sample should be collected using the dedicated collector. Please use the stool collector inside a toilet to avoid contamination with any chemical agents and prevent adulteration of the sample.
2. To examine stool samples: open the sample collection tube cap, then randomly pierce the sample collection applicator into the stool sample at least 3 points. Do not lift the stool sample. Ensure the cap is on the collection tube, then shake the tube vigorously to mix the sample and extraction buffer. Prepared samples in the collection tube can be stored up to 6 months at -20°C if not tested within an hour of preparation.
3. Bring the package to room temperature before opening. Remove the test support from the packaging and use it as soon as possible. Better results are achieved if the test is performed immediately after opening the package.
4. Keep the sample collection tube upright and open the cap. Invert the tube and transfer 2 full drops of the extracted sample (about 80 microliters) into the sample well (S) of the device, then start the timer. Avoid trapping air bubbles in the sample well (S).
5. Read results after 5 minutes. Do not interpret results after 10 minutes.

Results interpretation
POSITIVE*: two lines appear. One must always appear in the control line area (C) and another colored line must appear in the test area (T).
NEGATIVE: a colored line appears in the control area (C). No colored line appears in the test area (T).
INVALID: the control line does not appear. The most likely reasons for the control line not appearing are 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 intensity of the color in the test line area (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 Rapid Test (Stool) is an in vitro diagnostic device for individual use.
2. The rapid FOB (Stool) test indicates only the presence of Fecal Occult Blood; the presence of blood in stool does not necessarily indicate colorectal bleeding.
3. Like all rapid tests, all results should be interpreted together with other clinical information available to the doctor.
4. In case of doubtful 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 expiration date printed on the sealed packaging. 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.