Product Manual

TEST PROCEDURE
S
TEP 1. Remove device from pouch
and place on flat surface.
S
TEP 2. For serum or plasma fill a capillary
t
ube to the red line (10 µl).
For whole blood fill a capillary tube to the
black line (25 µl).
Apply sample by lightly tapping the capillary
t
ube on the pad of the UPPER AREA of the
Sample well (S).
S
TEP 3. Holding the bottle vertically, add 3 drops of
Developer Solution onto the LOWER AREA
of the Sample Well (S).
STEP 4. Read result at 10 minutes.
(Do not read after 15 minutes).
INTERPRETATION OF TEST RESULTS
Positive
One colored band each at the Test position (T) and at
the Control position (C) indicates that antibodies against
H. pylori have been detected.
Note: The test result can be read as soon as a distinct
pink-purple colored Test line (T) and a colored Control
line (C) appear. Any shade of pink-purple colored Test
line should be reported as a positive result.
Possible positive results :
• Two strong colored lines at both the Test (T) and Control (C) position or
• One strong Test line (T) and one light colored Control line(C) or
• One light colored Test line (T) and one strong colored Control line (C).
Negative
Only one colored Control line (C), with
no colored Test line (T) indicates that
antibodies against H. pylori have not
been detected.
Invalid
A distinctive colored Control line (C)
should always appear. The test is invalid
if no Control line forms. Repeat the test
with a new OSOM H. pylori Test.
USER QUALITY CONTROL
• A quality control check is recommended using H. pylori controls from Sekisui Diagnostics.
The frequency of Q.C. testing is determined according to your laboratory’s standard
Q.C. procedures. Upon confirmation of the expected results, the kit is ready for use with
patient specimens. If external controls do not perform as expected, do not use the test
kits. Repeat the test or contact Sekisui Diagnostics Technical Assistance.
• When the test has been performed correctly and the device is working properly, a
distinct colored line will always appear at the Control position (C). The colored line at
the Control position (C) is considered an internal positive procedural control. If the line
does not appear, a new device should be tested. If the problem persists, contact
Sekisui Diagnostics Technical Assistance.
• When the test has been performed correctly and the device is working properly, the
background in the Result window will clear, providing a distinct test result. This clearing
background in the Result window is considered an internal negative procedural control.
LIMITATIONS
• The results obtained by this kit should be used only to evaluate patients with other
clinical symptoms of gastrointestinal disease. This assay is not intended for use with
asymptomatic patients.
H. pyloriH. pyloriH. pylori
H. pyloriH. pyloriH. pylori
H. pyloriH. pyloriH. pylori
H. pylori
H
H. pylori
H
H. pylori
H. pylori
INVALID
STEP 1
STEP 2
STEP 3
NEGATIVE
POSITIVE
10 Min.