1 fecal occult blood test

Product Description

Sofarmapiu' rapid self-test for the detection of occult blood in stool.

Characteristics

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

Directions for use

Allow the test, sample, and swab to reach room temperature (15-30°C) before testing.

1. To collect stool samples: The stool sample must be collected in the stool collector. It is important to use the stool collector in all types of restrooms to avoid contaminating the sample with any type of chemical, so that no alterations to the sample occur.
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 places. Do not collect the stool sample. Screw and tighten the cap on the sample collection tube, then vigorously shake the sample collection tube to mix the sample and extraction buffer.
3. Bring the pouch to room temperature before opening it. 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. Attach the reaction tube, hold the sample collection tube upright, and break the tip of the sample collection tube. Invert the specimen collection tube and transfer 8-10 full drops of the extracted specimen (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 past the maximum line.
5. Read results at 5 minutes. Do not read 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 present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
   Negative: One 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 specimen 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-testing 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.
• Treat all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards 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 may adversely affect results.
• Keep out of reach of children.
• Do not freeze.
• Specimens 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 may cause gastrointestinal irritation resulting in occult bleeding. These substances should be discontinued at least 48 hours before testing.
• No dietary restrictions are necessary before using the FOB test.

Storage

Store at 2°C to 30°C.

Format

Package containing:

• FOB test;
• Information leaflet;
• Reaction tube;
• Specimen collection tube with extraction buffer;
• Stool collector.