Product Manual
Page 3 of 4
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
TEST PROCEDURE
All Test Cassettes and control reagent vials must be at room temperature before
beginning the test.
Remove the Test Cassette from the pouch and place it on a clean, at, dry,
level surface.
Remove the control reagent vial screw cap by turning.
Dispense six (6) drops of either the Positive or Negative control reagent into
the Sample Well.
READ RESULTS AT 5–10 MINUTES. Some positive results may be seen earlier.
IMPORTANT: Do not read the test results after ten (10) minutes.
INTERPRETATION OF RESULTS
Refer to the Procedure Card for visual color interpretation of the Test and Control Lines.
Both the T-line and the C-line present as the same burgundy color.
Positive Result:
If both a C-line and a T-line are present, the result is positive. A positive result
indicates the level of hHb in the specimen is at or above the detection level
(50 ng hHb/mL buer or 50 µg hHb/g feces).
Negative Result:
If only the C-line develops in the control region of the test strip, the result is negative.
A negative result indicates the hHb in the specimen is below 50 ng/mL.
Invalid Result:
If no C-line appears within 5 minutes, the test result is invalid and the control sample
must be retested. An invalid result indicates either the assay was not performed
correctly or the reagents were not working properly. If an invalid result occurs, retest
the control sample using a new test unit. If the problem persists, please contact Quidel
Technical Support.
LIMITATIONS
The QuickVue iFOB Control Set contains qualitative reagents, which are not to be used as
quantitative calibrators. The controls should not be diluted and may be incompatible for
use with other assays.
The QuickVue iFOB Control Set must be used at room temperature 59–86°F (15–30°C).
Performance of the assay at other temperatures may yield invalid results.