Coretests - One Step Fecal Occult Blood Test Device

INTENDED USE: The 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 COLLECTION AND STORAGE

1. Collect stool specimen by using the sample collection tube provided.
2. 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.
3. Replace the stick in the sample collection tube and screw tightly.
4. 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

1. Bring the pouched test device to room temperature (15-30?) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch.
3. Specimen collection. Please see “SPECIMEN COLLECTION AND STORAGE”.
4. Shake the sample collection tube well.
5. Holding the sample collection tube upright, carefully break off the tip of collection tube.
6. Squeeze 3 drops of sample solution into the sample well “S” .
7. Read results between 5-10 minutes. Do not read results after 10 minutes.