Product Manual

Page 9 of 12
FOR INFORMATIONAL USE ONLY

FOR INFORMATIONAL USE ONLY
Not to be used for performing assay. Refer to most current package insert accompanying your test kit.
QuickVue iFOB TEST
LIMITATIONS
The QuickVue iFOB test is intended only for the detection of human hemoglobin in feces.
 Results cannot be considered conclusive evidence of the presence or absence of
gastrointestinal bleeding or pathology. A positive result should be followed up with
additional diagnostic procedures to determine the exact cause and source of the
occult blood in the feces.
 A negative result can be obtained even when a gastrointestinal disorder is present.
For example, some polyps and colorectal cancers may bleed intermittently or not at
all during certain stages of the disease.
 False negative results may occur when occult blood is not uniformly distributed
throughout the bowel movement and the formation of a fecal specimen. Repeat
testing is recommended if a pathological condition is suspected.
Patients with the following conditions should not be considered for testing, as these
conditions may interfere with test results:
 Menstrual bleeding
 Bleeding hemorrhoids
 Constipation bleeding
 Urinary bleeding
However, these patients may be considered for testing after such bleeding ceases.
Alcohol and certain medications such as aspirin, indomethacin, reserpine, phenylbutazone,
corticosteroids and nonsteroidal anti-inflammatory drugs may cause gastrointestinal
irritation and subsequent bleeding in some patients.
EXPECTED RESULTS
The QuickVue iFOB test will show positive results if there is a detectable amount of
human hemoglobin in the specimen. The detection level is 50 ng hHb/mL buffer or
50 µg hHb/g feces.