One-Step Fecal Occult Blood (FOB) Test Device

• Instructions for use 
• Feces collection tube

Immunochromatographic assay

The One-Step Fecal Occult Blood Test Device is a qualitative test that detects human hemoglobin in human fecal specimens. The test is a visual one-step, in vitro assay. It is intended for professional use to help diagnose gastrointestinal bleeding.

Specimen Preparation:

• Collect the stool specimen by using the sample collection tube provided.
• Unscrew the top of the sample collection tube, take out the sample collection stick and collect the specimen by dipping the stick into 3 different places of the stool specimen.
• Replace the stick in the sample collection tube and screw tightly.
• If the specimen cannot be tested on the day of collection, store the stool specimen at 2-8℃. Bring the specimen to room temperature before testing.

Test Procedure:

• Bring the pouched test device to room temperature (15-30℃) before testing. Do not open the pouch until ready to perform the assay.
• Remove the test device from the sealed pouch.
• Specimen collection.
• Shake the sample collection tube well.
• Holding the sample collection tube upright, carefully break off the tip of the collection tube.
• Squeeze 3 drops of sample solution into the sample well.
• Read results between 5-10 minutes. Do not read results after 10 minutes.

• Positive: Two colored lines appear in the result window, one in the test region and another in the control region. This indicates a positive result regardless of if the test line is stronger or weaker than the control line.
• Negative: Only the control line appears in the result window. This indicates a negative test result.
• Invalid: If the control line does not appear, the test results are invalid regardless of the presence or absence of the test line. (NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If the problem persists, contact your local distributor.)