FAQ's
(Frequently Asked
Questions)
How does Immunoassay
FOB Testing differ from a guaiac-based test(s)? What
are the advantages?
Conventional guaiac-based tests used for the detection of fecal occult
blood do not provide a high degree of accuracy. Guaiac-based tests are
highly affected by a patient’s diet, due to the fact that the
assay is testing for the presence of peroxidase activity. However, apart
from human hemoglobin, other substances have similar peroxidase activity,
such as meat, certain vegetables, fruit and certain drugs (i.e. Vitamin
C). Patients must abstain from consuming any of these items for 3 days
prior to taking the guaiac test. Also three samples from three separate
bowel movements must be obtained.
Clearview ULTRA FOB test and OC-Auto Micro
80 are immunological based tests that are specifically designed to test
for the presence of human hemoglobin in feces. This will increase sensitivity
and specificity while decreasing false positives and false negatives.
There is no need for patients to adhere to any dietary restrictions.
The sampling procedure is user friendly, requiring virtually no fecal
handling and only 1 sample versus the 3 required for guaiac-based tests.
Patient compliance will increase based on the added convenience.
What
Immunoassay Fecal Occult Blood Tests (iFOBT) are available?
Clearview Ultra FOB Test - a rapid manual Point of Care (POC) dipstick
test with a 5 minute read time.
OC-Auto Micro 80 - an automated Fecal Occult Blood
analyzer that can run up to 10 samples per rack with results available
in 8 minutes.
How do the Clearview
ULTRA FOB and OC-Auto Micro 80 Tests differ?
Both the Clearview Ultra FOB and OC-Auto Micro 80 tests are immunological
tests intended to detect the presence of Hemoglobin in feces. The Clearview
ULTRA FOB is a manual point of care assay that utilizes a dipstick on
which the chemical reaction takes place and a result can be determined.
The OC-Auto Micro 80 is an automated instrument that can perform up
to 10 samples per rack with an 8 minute turnaround time.
Are there any
dietary restrictions associated with the iFOBT testing?
There are no dietary restrictions with the test(s). It is not necessary
to avoid meats, vegetables, or Vitamin C before collection of the sample.
What are the recommended
storage conditions?
Clearview Ultra FOB Test should be stored
at 2-30°c
OC-Auto Micro 80 test reagents should be stored at 2-8°c and sample
containers/test devices may be stored at 2-30°c
How long can the fecal
sample be stored before testing?
Once sample has been added to the sampling container it is stable for
5 days at ambient temperature and 14 days at 2-8° c
Can other types
of samples be used with the test(s)?
The only approved sample type for both the Clearview ULTRA and the OC-Auto
Micro 80 is human stool.
How is the Clearview
ULTRA FOB Test interpreted?
The appearance of two lines, one in the test region and one in the control
region indicates a positive result. A single line in the control region
indicates a negative result. No control line even in the presence of
a test line indicates an invalid result .
What if no line appears
in the "C" region of the Clearview ULTRA FOB Test?
If no line appears in the procedural control region, the test is invalid
and must be repeated with a new dipstick.
How is the OC-Auto
Micro 80 Test interpreted?
The OC-Auto Micro 80 is an automated analyzer with the capability of
printing out qualitative results or sending the results directly to
your LIS (Laboratory Information System).
Should I take the
test if I have hemorrhoids that are bleeding?
You should not use the Clearview ULTRA FOB test or the OC-Auto Micro
80 test if you have any actively bleeding hemorrhoids, however you may
take the test after such bleeding ceases.
Can I take the test
if I am menstruating?
You should not use the Clearview ULTRA FOB test or the OC-Auto Micro
80 test if you are menstruating, however you may take the test after
such bleeding ceases.
