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1.
What is included in a kit?
2.
What are the recommended storage
conditions for the testing
device and the specimens?
3.
For the dip strips, how far
should the strip be dipped into
the specimen?
4.
How do I know if the test worked
properly?
5.
How are the results interpreted?
6.
What should I do with a positive
result?
What is
included in a kit?
Kits are available as follows:
Cassette test: 25 tests/kit and one
instruction sheet
Dip Strip test: 50 tests/kit and one
instruction sheet
What are
the recommended storage conditions
for the testing device and the
specimens?
The kit, including the test strips,
cassette or multi-panel devices, can
be stored at room temperature 15-30C
(59-86F) until the printed
expiration date on the label if it
remains sealed in its pouch
containing desiccant. Serum
specimens can be stored at 20C to
28C room temperature for 8 hours, at
2-8C for one week, and at -20C or
lower for prolonged storage. For
whole blood specimens, it is
recommended to use fingerstick
sampling. The specimen should be
used immediately following
collection.
For the
dip strips, how far should the strip
be dipped into the specimen?
When performing the dip strip
method, make sure to dip the test
strip into the specimen for at least
10 seconds. Make sure to keep the
specimen below the level indicated
by the arrows on the test strips.
How do I
know if the test worked properly?
The tests have a built-in control
line to show the test is working
properly. If the Control (C) line
does not appear, repeat the test
with a new device. External controls
may be used according to local
laboratory guidelines.
How are
the results interpreted?
HBsAg Test
Read the test results between five
(5) to fifteen (15) minutes after
adding the specimen. The results
should not be read after
fifteen(15)
minutes.
Negative: The
absence of a Test (T) line indicates
that there is no Hepatitis B Antigen
detected in the specimen or the
Hepatitis B Antigen in the specimen
is below the level of detection with
this assay and the result is
negative.
Positive: If the C
line and the T line both appear, the
result indicates that there is a
presence of HBsAg at 1 ng/ml or
higher.
Invalid: If no C
line develops within five (5)
minutes, the test should be voided.
In this case, repeat the test with a
new testing device.
HCV
Read the test results between five
(5) to fifteen (15) minutes after
adding the specimen. The results
should not be read after fifteen
(15) minutes.
Negative: The
absence of a Test (T) line indicates
that antibodies specific to
Hepatitis C antibody were not
detected in the specimen and the
test result is negative.
Positive: If the C
line and the T line both appear, the
result indicates that antibodies
specific to Hepatitis C are detected
in the specimen. When the level of
antibodies to HCV is very low, the T
line might appear as a faded
burgundy line.
Invalid: If no C
line develops within five (5)
minutes, the test should be voided.
In this case, repeat the test with a
new testing device.
*Always refer to the
product instruction sheet included
with each kit for complete testing
instructions.
What should I
do with a positive result?
Samples with positive results should
be confirmed with a more specific
method and a medical doctor should
be consulted for a positive
determination to be made. |