INTENDED USE
The Rapid Fecal Occult Blood (FOB) Card Test is an immunochromatographic assay intended for the determination of human hemoglobin in feces by professional laboratories or physician’s offices.  It is useful to determine gastrointestinal bleeding founding a number of gastrointestinal disorders such as colorectal carcinoma, colon polyps, diverticulitis and ulcerative colitis.

The Rapid Fecal Occult Blood (FOB) Card Test is recommended for use in 1) routine physical examination, 2) hospital monitoring for bleeding in patients, and 3) screening for colorectal cancer or gastrointestinal bleeding from any source.

-CPT: 82274QW($22.22) Reimbursement indicates National Average

-FDA 510K & CLIA WAIVED

REAGENTS AND MATERIALS PROVIDED

1. 25 Test Devices
2. 25 Sample Collection Tubes
3. 1 Product Package Insert
4. 1 Bottle FOB buffer 2ml

SAMPLE COLLECTION AND PREPARATION

1. Collect a random sample of feces in a clean, dry receptacle.
2. Unscrew the top of the collection tube and remove the applicator stick.
3. Insert the stick into the fecal specimen at several different sites.
4. Collect a thin smear of specimen on the probe tip section only. Remove excess sample from the stick by gently wiping with an absorbent tissue.
5. Replace the stick in the tube and tighten securely. 

TEST PROCEDURE

1. Shake the tube vigorously to ensure a good liquid suspension.
2. Holding the tube upright, snap off the tip.
3. Dispense 2 - 3 drops of solution into the sample (S) well.
4. Wait five minutes and read the result.

 IMPORTANT: The result must be interpreted between 5 and 10 minutes.  Waiting more than ten minutes may cause the reading to be inaccurate. 

INTERPRETATION OF RESULTS

Negative:  At five minutes, one rose-pink color band appears in the control (C) zone indicating a negative result and that the specimen does not contain a detectable level of human hemoglobin.

Positive:    At five minutes, two rose-pink color bands appear: one in the test (T) zone and one in the control (C) zone.  A positive result indicates that the specimen contains human hemoglobin. A positive result may be read sooner than 5 minutes.

Invalid:     At five minutes, no bands appear, or a test band appears without a control band, disregard the result, indicating the test is invalid.  It is recommended that the specimen be re-tested. 

Note:  There is no meaning attributed to line color intensity or width. A positive result may be read sooner than 5 minutes; however, a negative result must be read after 5 minutes.