Description
Rapid chromatographic immunoassay for the qualitative detection of human occult blood in feces.
The membrane is pre-coated with an anti-hemoglobin antibody in the test line region. During analysis, the sample reacts with the anti-hemoglobin antibody-coated particles.
The mixture migrates upward by capillary action on the membrane, reacting with the anti-hemoglobin antibody present on the membrane, forming a colored line. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result.
As a procedural control, a colored line always appears in the control region to indicate that the correct volume of sample has been added and that capillary action has acted on the membrane.

How to use
Before testing, allow the sample and swab to reach room temperature (15-30°C).
Do not collect samples during menstruation or within three days of it, or if patients have bleeding hemorrhoids or blood in their urine.
Excessive alcohol, aspirin, and other medications can cause gastrointestinal irritation, resulting in occult bleeding. Discontinue use of these substances at least 48 hours before the test.
No dietary restrictions are required before using the Occult Blood Test.
The stool sample must be placed in the appropriate container. Use the container to avoid contaminating the sample with any type of chemical, thus preventing adulteration.
Unscrew the cap of the sample collection tube and randomly insert the sample collection applicator into at least three different spots on the stool sample. Do not dig into the stool sample. Screw and tighten the cap on the sample collection tube and shake vigorously to mix the sample and extraction buffer.
Bring the pouch to room temperature before opening. Remove the test cassette from the pouch and use it as soon as possible. For best results, perform the test immediately after opening the pouch.
Hold the sample collection tube upright and open the cap. Invert the sample collection tube and transfer 2 drops of the extracted sample (approximately 80 mcL) into the sample well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the sample well (S).
Read the result after 5 minutes. Do not read the results after 10 minutes.
Interpretation of the results
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).
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: A colored line appears in the control line region (C). No line appears in the test line region (T).

NULL: 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-testing only.
Do not use after the expiration date.
The test must remain in the sealed pouch until ready for 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 accepted precautions against microbiological hazards during all procedures and dispose of specimens according to standard procedures.
Used tests must be disposed of according to local regulations.
Humidity and temperature can negatively affect results.
Keep out of reach of children.
The test will only indicate the presence of occult blood in the stool; the presence of blood in the stool does not necessarily indicate colorectal bleeding.
As with all diagnostic tests, it is essential to consider all results in conjunction with other clinical information available to the physician.
If doubtful results are obtained, other clinically available tests are necessary.

Conservation
The kit can be stored at room temperature or refrigerated (2-30°C). Do not freeze.
The test cassette is stable until the expiration date printed on the sealed pouch. The test cassette must remain in the sealed pouch until use. Do not use beyond the expiration date.
Shelf life in intact packaging: 24 months.

Format
The kit contains:
- dipstick test;
- stool collector;
- reaction tube;
- sample collection tube with extraction swab;
- package leaflet.

Bibliography
1. Simon JB. Occult Blood Screening for Colorectal Carcinoma: A Critical Review, Gastroenterology, Vol. 1985; 88:820.
2. Blebea J, Mcpherson RA. False-Positive Guaiac Testing With Iodine, Arch Pathol Lab Med, 1985;109:437-40.

Cod. MM-TFO-602H