SOFARMAPIU' RAPID SELF-DIAGNOSTIC TEST FOR THE DETECTION OF OCCULT BLOOD IN FECES

TEST
OCCULT BLOOD
IN THE FECES (FOB)

Description
Rapid chromatographic immunoassay for the qualitative detection of human occult blood in stool. For in vitro diagnostic self-testing only.

How to use
Allow the test, specimen, and swab to reach room temperature (15-30°C) before testing.
1. To collect fecal samples: The stool sample must be collected in a stool collector. It is important to use the stool collector in all types of restrooms to avoid contamination of the sample with any type of chemical, thus preventing sample adulteration.
2. To process stool samples: Unscrew the cap of the sample collection tube, then randomly insert the sample collection applicator into the stool sample in at least 3 different locations. Do not collect the stool sample. Screw and tighten the cap on the sample collection tube, then shake the sample collection tube vigorously to mix the sample and extraction buffer.
3. Bring the pouch to room temperature before opening. Remove the dipstick from the foil pouch and use it as soon as possible. Best results are obtained if the test is performed immediately after opening the foil pouch.
4. Secure the reaction tube, hold the sample collection tube upright, and break the tip of the sample collection tube. Invert the sample collection tube and transfer 8-10 full drops of the extracted sample (approximately 500 mcl) into the reaction tube. Then immerse the dipstick with the arrows pointing toward the extraction buffer and start the timer. Do not immerse the dipstick beyond the maximum line.
5. Read the results after 5 minutes. Do not read the results after 10 minutes.
Positive: Two colored lines appear. One colored line should be in the control line region (C) and another colored line should be in the test line region (T).
Note: The intensity of the color in the test line region (T) will vary 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.
Negative: A colored line appears in the control line region (C). No line appears in the test line region (T).
Invalid: The control line does not appear. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue use of the test kit immediately and contact your local distributor.

Warnings
- For in vitro diagnostic self-analysis only.
- Do not use after the expiration date.
- The test must remain in the sealed pouch until use.
- Do not eat, drink or smoke in the area where specimens or kits are handled.
- Handle all specimens as if they contain infectious agents. Observe established microbiological precautions during all procedures and follow standard procedures for proper specimen disposal.
- The used test must be disposed of according to local regulations.
- Humidity and temperature can negatively affect results.
- Keep out of reach of children.
- Do not freeze.
- Samples should not be collected during or within three days of a menstrual cycle, or if the patient suffers from bleeding hemorrhoids or blood in the urine.
- Alcohol, aspirin, and other medications taken in excess can cause gastrointestinal irritation resulting in occult bleeding. These substances should be discontinued at least 48 hours before the test.
- No dietary restrictions are required before using the FOB test.

Conservation
Store between 2°C and 30°C.

Format
Package containing:
FOB test;
package leaflet;
reaction tube;
sample collection tube with extraction swab;
feces collector.

Cod. SF-018