Product Manual

Page 2 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
PRINCIPLE OF THE TEST
The QuickVue iFOB test is a one-step lateral flow chromatographic immunoassay. The
test strip consists of: (1) a burgundy colored conjugate pad containing mouse anti-hHb
antibodies conjugated with colloidal gold and (2) a nitrocellulose membrane strip
containing a Test line (T-line) and a Control line (C-line). The T-line is coated with anti-hHb
antibodies, and the C-line is coated with goat anti-mouse IgG antibodies.
When the correct volume of test specimen is dispensed into the sample well of the
device, the test specimen migrates across the test strip. If the concentration of hHb in
the specimen is at or above 50 ng hHb/mL or 50µg hHb/g feces, the T-line appears
as a visible burgundy line. If the concentration of hHb in the specimen is below the
detectable level, no T-line develops.
The C-line is coated with goat anti-mouse antibody, which binds to the conjugated
monoclonal antibody, regardless of the presence of hHb in the specimen.
REAGENTS AND MATERIALS SUPPLIED
MATERIALS REQUIRED BUT NOT PROVIDED
Timing Device.
Specimen Collection and Return Kits, each consisting of:
Specimen Collection Tube (1), with 2 mL FOB buffer
(1x PBS with 0.02% sodium azide) and
Patient Identification Label
Specimen Collection Paper with Adhesive (1)
Specimen Pouch (1)
Absorbent Sleeve (1)
Return Mailer (1)
Patient Instructions (1)
20194
20205
20
100
1
1
1
0
20
0
Description/Catalog #
Individually Wrapped Test Cassettes
Package Insert
Procedure Card