Product Manual

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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.
iFOB Control Set
iFOB Control Set
(Negative and Positive)
INTENDED USE
The QuickVue iFOB Control Set is intended for use with the QuickVue iFOB
(immunochemical Fecal Occult Blood) test. These controls provide an aid in
the interpretation of positive and negative test results and verify proper test
performance.
SUMMARY AND EXPLANATION
The QuickVue iFOB Control Set contains two vials – one negative and one positive –
for use in verifying the performance of the QuickVue iFOB test. Elevated levels
(50 ng hHb/mL buer or 50 µg hHb/g feces) of human hemoglobin are an indication
of gastrointestinal disorders such as diverticulitis, colitis, and polyps, which may lead
to colorectal cancer if not treated.
When used as qualitative controls in place of patient specimen, the results may aid
in the interpretation of positive and negative results and verify test performance.
PRINCIPLE OF THE TEST
The QuickVue iFOB Control Set is designed for use as external qualitative control samples
when used in accordance with the QuickVue iFOB test package insert procedure.
REAGENTS AND MATERIALS SUPPLIED
 One (1) vial (2.0 mL) Negative Control: Contains buered solution, with 0.02% sodium
azide as preservative.
 One (1) vial (2.0 mL) Positive Control: Contains hemoglobin of human origin in
buered solution, with 0.02% sodium azide as preservative.
 Package Insert (1)
MATERIALS REQUIRED BUT NOT PROVIDED
 QuickVue iFOB test cassette
 Timer or watch